Tags

Localized prostate cancer

  • [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer

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    [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer


    Condition: Prostate Cancer

    Intervention:

    • Drug: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone

    Purpose: This study will use PET scans, which is a type of x-ray test that uses a radiotracer, to see whether these scans may be better able to find places in the body where your prostate cancer may have spread.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT00588185

    Sponsor: Memorial Sloan Kettering Cancer Center

    Primary Outcome Measures:

    • Measure: To study the accumulation and biodistribution of FDHT in patients with progressive prostate cancer. The accumulation and location of FDHT activity will be assessed on a site by site basis and correlated with radionuclide bone scan, CT and MRI.
    • Time Frame: Baseline, 4 weeks and 12 weeks
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: The kinetics, metabolism, and biodistribution will be assessed.
    • Time Frame: Baseline. 4 weeks and 12 weeks
    • Safety Issue:
    • Measure: To correlate the accumulation of 18FDHT to 18FDG.
    • Time Frame: 2 years
    • Safety Issue:
    • Measure: To study changes in 18FDHT accumulation over time in patients treated with: Castration and other hormones, Chemotherapy, Agents directed toward the androgen receptor
    • Time Frame: 2 years
    • Safety Issue:
    • Measure: relationship between FDHT uptake and tumor diffusivity
    • Time Frame: 2 years
    • Safety Issue:
    • Measure: relationship between FDHT uptake and tissue analyses
    • Time Frame: 2 years
    • Safety Issue:

    Estimated Enrollment: 300

    Study Start Date: February 2003

    Eligibility:

    • Age: minimum N/A maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Patients with histologically confirmed prostate cancer.
    • Progressive disease manifest by either:
    • Imaging modalities:
    • Bone Imaging: New osseous lesions on bone imaging (bone scintigraphy or NaF PET scan) and/or MRI or CT: An increase in measurable soft tissue disease, or the appearance of new sites of disease. Or
    • Biochemical progression: A minimum of three rising PSA values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart.
    • Visible lesions by either CT, bone imaging, or MRI consistent with disease.
    • Informed consent.

    Exclusion Criteria:

    • Previous anaphylactic reaction to either FDHT or FDG
    • Hepatic: Bilirubin > 1.5 x upper limit of normal (ULN), AST/ALT >2.5 x ULN, albumin < 2 g/dl, and GGT > 2.5 x ULN IF Alkaline phosphatase > 2.5 x ULN
    • Renal: Creatinine >1.5 x ULN or creatinine clearance < 60 mL/min

    Contact:

    • Michael Morris, M.D., PH.D.
    • 646-422-4469

    Location:

    • Memorial Sloan Kettering Cancer Center
    • New York New York 10065 United States

    View trial on ClinicalTrials.gov


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    Published March 5, 2017
  • 3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate

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    3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate


    Condition: Prostate Cancer

    Intervention:

    • Procedure: 3T Magnetic Resonance Spectroscopic Imaging

    Purpose: Objectives: The objectives of this study are to: 1) evaluate the feasibility of 3T MRSI of prostate in improving the spectral resolution, using a PFC-filled endorectal coil, 2) develop a systematic metabolic grading system for tumor detection by identifying the abnormal peak areas of Cho, Cr, Po, and Ci for the prostate carcinoma, specifically from PFC-filled endorectal 3T MRSI, and 3) evaluate the efficacy of the metabolic grading system in tumor detection. The long-term goal of the study is to provide an early prognostic indicator and means of monitoring the biologic status of the prostate cancer during the course of the disease.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT00464724

    Sponsor: M.D. Anderson Cancer Center

    Primary Outcome Measures:

    • Measure: Comparison of linewidths collected from AIR MRSI and PFC-MSRI
    • Time Frame: 2 MRSI studies should take about 60 minutes; study participation completed with prostatectomy to take place within 3 months of MRSI exams
    • Safety Issue:

    Estimated Enrollment: 80

    Study Start Date: March 2007

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    1. Biopsy proven, clinical stage 1-3 prostate carcinomas
    2. Prostatectomy at M. D. Anderson within 3 months from the time of MRSI
    3. An interval of > 6 weeks between the biopsy and MRSI
    4. Signed informed consent form

    Exclusion Criteria:

    1. Contraindications for MRI (e.g. cardiac pacemaker)
    2. Contraindications for MRS (e.g. history of abdomino-perineal resection of rectum)
    3. Metals or any conditions (e.g. hip prosthesis) that can distort the local magnetic field
    4. Previous prostate surgery for prostate carcinoma (including, TURP and cryosurgery), local or systemic treatment for prostate carcinoma (e.g. radiation, androgen deprivation), pelvic radiation (e.g. rectal cancer), rectal surgery, BCG for bladder cancer

    Contact:

    • Haesun Choi, MD
    • 713-745-4693

    Location:

    • University of Texas MD Anderson Cancer Center
    • Houston Texas 77030 United States

    View trial on ClinicalTrials.gov


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    Published March 5, 2017
  • A Comprehensive, Multimodality Quality of Life Study for Prostate Cancer Patients

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    A Comprehensive, Multimodality Quality of Life Study for Prostate Cancer Patients


    Condition: Prostate Cancer

    Intervention:

    • Behavioral: Questionnaire

    Purpose: The goal of this behavioral research study is to look at patients' quality of life after treatment or management for prostate cancer.

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT00561444

    Sponsor: M.D. Anderson Cancer Center

    Primary Outcome Measures:

    • Measure: QOL: Expanded Prostate Cancer Index Composite (EPIC) Survey
    • Time Frame: Survey prior to beginning treatment, 3 months after completing treatment, 6 months after completing treatment, at 6 month intervals for the first 2 years post-treatment, and then yearly for 3 more years.
    • Safety Issue:

    Estimated Enrollment: 1448

    Study Start Date: November 2007

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    1. Primary treatment at MD Anderson for prostate cancer using: radical retropubic prostatectomy, robotic prostatectomy, photon external beam radiation, photon external beam radiation with hormone therapy, proton radiation, radioisotopic implant, cryotherapy, or active surveillance.
    2. Neoadjuvant, concurrent and adjuvant androgen ablation in conjunction with photon external beam radiation is allowed if not greater than 6 months total duration. Hormone therapy will be given as an LHRH agonist with or without an antiandrogen.
    3. Pathologic diagnosis of prostate adenocarcinoma
    4. AJCC (VI) stage T1-T3b N0M0
    5. Ability to read, write, and fill out the self-survey questionnaires
    6. Patients may be simultaneously enrolled on other MD Anderson treatment or laboratory protocols. The EPIC Survey will be used for both this protocol and for protocol 2007-0209 such that patients enrolled on both protocols will complete only one document at each survey point. Simultaneous enrollment on other survey protocols will be handled in a similar manner.

    Exclusion Criteria:

    1. Histology other than adenocarcinoma
    2. Stage T4, nodal or distant metastasis
    3. Prior treatment for prostate cancer except for neoadjuvant, concurrent and adjuvant androgen deprivation of 6 months or less duration in patients treated with photon radiation. Hormone therapy in all other modalities is not allowed.
    4. Chemotherapy or molecular targeting therapy as primary, neoadjuvant or adjuvant treatment
    5. Treatment for another pelvic malignancy, to include surgery or radiation
    6. Treatment for another malignancy with chemotherapy completed within one year or less of treatment for prostate cancer.
    7. Inflammatory bowel disease (eg. Crohn's or Ulcerative Colitis)
    8. Patients 18 years or younger.

    Contact:

    • Deborah A. Kuban, MD
    • 713-563-7382

    Locations:

    • MD Anderson at Cooper
    • Voorhees Township New Jersey 08043 United States
    • MD Anderson Cancer Center at Albuquerque
    • Albuquerque New Mexico 87110 United States
    • University of Texas MD Anderson Cancer Center
    • Houston Texas 77030 United States

    View trial on ClinicalTrials.gov


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    Published March 5, 2017
  • A Feasibility Study of Oral Hormonal Therapy and Radiation for Non-metastatic, Intermediate or High Risk Prostate Cancer in Men 70 and Older or With Medical Comorbidities

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    A Feasibility Study of Oral Hormonal Therapy and Radiation for Non-metastatic, Intermediate or High Risk Prostate Cancer in Men 70 and Older or With Medical Comorbidities


    Condition: Prostate Cancer

    Intervention:

    • Drug: Bicalutamide
    • Drug: Dutasteride
    • Drug: Finasteride
    • Radiation: Radiation

    Purpose: The purpose of this study is see if quality of life is improved in patients receiving oral hormone therapy compared to standard of care. The study will also compare survival rates between patients receiving oral hormone therapy and those receiving standard of care.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01342367

    Sponsor: University of Chicago

    Primary Outcome Measures:

    • Measure: Quality of Life
    • Time Frame: 6 months
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Progression Free Survival
    • Time Frame: 5 years
    • Safety Issue:

    Estimated Enrollment: 40

    Study Start Date: December 17, 2010

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Age > or = 70 years and/or Charlson comorbidity index score > or = 2
    • Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma
    • Two or more of the following intermediate risk features for recurrence, Gleason Score = 7, PSA 10-20 ng/ml, Clinical Stage T2b-T2c Percent positive biopsy cores > or = 50%
    • One or more of the following high risk features for recurrence, Gleason Score 8-10, PSA > 20 ng/ml, Clinical Stage T3a-T4
    • Clinically negative lymph nodes as established by imaging, nodal sampling, or dissection
    • No evidence of bone metastases on bone scan
    • History/physical examination via the Charlson Comorbidity Index within 60 days prior to registration
    • Zubrod Performance Status 0-2
    • Age > or = 18
    • Baseline serum PSA within 60 days prior to registration
    • Baseline serum testosterone obtained within 60 days prior to registration
    • Study entry PSA and serum testosterone must not be obtained during the following time frames, 10-day period following prostate biopsy, following initiation of oral androgen manipulation, within 30 days after discontinuation of finasteride or dutasteride
    • CBC/ differential obtained within 60 days prior to registration with adequate bone marrow function
    • Patient must be able to provide study-specific informed consent prior to study entry
    • Liver function parameters as follows, Total Bilirubin < or = 2 x institutional upper limit of normal, AST (SGOT) or ALT (SGPT) < or = 2 x institutional upper limit normal

    Exclusion Criteria:

    • Prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery for prostate cancer
    • Prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy
    • Use of 5-alpha reductase inhibitors (finasteride, dutasteride) specifically prescribed for the treatment of prostate cancer
    • Prior or concurrent cytotoxic chemotherapy for prostate cancer; prior chemotherapy for a different cancer is permitted
    • Prior radiation, including brachytherapy, to the region of the prostate that would result in overlap of RT fields
    • Active lupus or scleroderma
    • Severe, active co-morbidity, including but not limited to,unstable angina within the last 6 months without subsequent corrective cardiovascular procedure,or acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Hepatic insufficiency with AST, ALT, or Bilirubin > 2 x upper limit of normal,clinical jaundice, and/or coagulation defects
    • Acquired Immune Deficiency Syndrome (AIDS); note, however, that HIV testing is not required for entry into this protocol.Patients who are HIV seropositive but do not meet criteria for diagnosis of AIDS are eligible for study participation

    Location:

    • University of Chicago
    • Chicago Illinois 60637 United States

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • A Feasibility Study to Evaluate the Safety and Initial Effectiveness of ExAblate MR Guided Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System

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    A Feasibility Study to Evaluate the Safety and Initial Effectiveness of ExAblate MR Guided Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System


    Condition: Bone Metastases

    Intervention:

    • Device: ExAblate 2100

    Purpose: A study to evaluate the safety and initial effectiveness of the ExAblate 2100 Conformal Bone System in the treatment of pain resulting from metastatic bone tumors.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT00981578

    Sponsor: InSightec

    Primary Outcome Measures:

    • Measure: Adverse device effects
    • Time Frame: 3 months
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Pain scores
    • Time Frame: 3 months
    • Safety Issue:
    • Measure: Quality of life
    • Time Frame: 3 months
    • Safety Issue:
    • Measure: Changes in pain medications
    • Time Frame: 3 months
    • Safety Issue:

    Estimated Enrollment: 50

    Study Start Date: September 2009

    Phase: Phase 1

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • 1. Men and women age 18 and older 2. Patients who are able and willing to give consent and able to attend all study visits 3. Patients who are suffering from symptoms of bone metastases 4. One to 3 painful lesions. 5. Targeted tumor(s) are ExAblate device accessible and are located in ribs, extremities (excluding joints), pelvis, shoulders and in the posterior aspects of the following spinal vertebra: Lumbar vertebra (L3
    • L5), Sacral vertebra (S1
    • S5) 6. Patients with persistent distinguishable pain associated with up to 3 tumors of which a maximum of 2 tumors will be treated: o If patient has pain from additional sites that are not planned for treatment, the pain from the additional sites must be evaluated as being less intense by at least 2 points on the NRS compared to the site(s) to be treated. 7. Patient with NRS (0-10 scale) pain score ≥ 4 at the targeted tumors (i.e: both tumors targeted for treatment must have NRS ≥ 4) irrespective of medication 8. Targeted tumors (most painful) size up to 8 cm in diameter 9. Patient whose targeted (most painful) tumors are on bone and bone-lesion interface is deeper than 1cm from the skin. 10. Targeted (most painful) tumors clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible 11. Able to communicate sensations during the ExAblate MRgFUS treatment 12. At least 2 weeks since chemotherapy 13. No radiation therapy to targeted (most painful) tumors in the past two weeks

    Exclusion Criteria:

    • 1. Patients who either
    • Need surgical stabilization of the affected weight bearing bony structure (>7 fracture risk score, see Section 6.9) OR
    • Targeted tumor is at an impending fracture site of the weigh bearing bone (>7 on fracture risk score, see Section 6.9). OR o Patients with surgical stabilization of tumor site with metallic hardware 2. More than 3 painful lesions or more than 2 requiring immediate localized treatment 3. The targeted tumor(s) is (are) less than 2 points more painful compared to other non-targeted painful lesions on the site specific NRS. 4. Targeted tumor is in the skull 5. Patients on dialysis 6. Patients with life expectancy < 6-Months 7. Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study. 8. Patients with unstable cardiac status including:
    • Unstable angina pectoris on medication
    • Patients with documented myocardial infarction within six months of protocol entry
    • Congestive heart failure requiring medication (other than diuretic)
    • Patients on anti-arrhythmic drugs 9. Severe hypertension (diastolic BP > 100 on medication) 10. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc. 11. Patients with an active infection or severe hematological, neurological, or other uncontrolled disease. 12. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease 13. KPS Score < 60 (See "Definitions" below) 14. Severe cerebrovascular disease (multiple CVA or CVA within 6 months) 15. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 4 hrs of total table time.) 16. Target (most painful) tumor-bone interface is less then 1cm from nerve bundles, bowels or bladder. 17. Are participating or have participated in another clinical trial for the palliation of their targeted bone metastasis tumors in the last 30 days 18. Patients receiving chemotherapy or radiation (i.e., to the targeted lesion (s)) within the last two weeks 19. Patients unable to communicate with the investigator and staff. 20. Patients with persistent undistinguishable pain (pain source unidentifiable) 21. Targeted (most painful) tumors size > 8 cm in diameter 22. Targeted (most painful) tumors:
    • NOT visible by non-contrast MRI, OR
    • NOT accessible to ExAblate device

    Locations:

    • City of Hope
    • Duarte California 91010 United States
    • University of California San Francisco
    • San Francisco California 94107 United States
    • Stanford University Medical Center
    • Stanford California 94305 United States
    • Methodist Hospital Research Institute
    • Houston Texas 77030 United States
    • University of Virginia
    • Charlottesville Virginia 22908 United States

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • A First-in-Man, Phase I Evaluation of A Single Cycle of Prohibitin Targeting Peptide 1 in Patients With Metastatic Prostate Cancer and Obesity

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    A First-in-Man, Phase I Evaluation of A Single Cycle of Prohibitin Targeting Peptide 1 in Patients With Metastatic Prostate Cancer and Obesity


    Condition: Prostate Cancer

    Intervention:

    • Drug: Prohibitin-TP01

    Purpose: The goal of this clinical research study is to find the highest tolerable dose of PROHIBITIN-TP01 that can be given to patients with advanced prostate cancer for which there are no standard therapy options. The safety of this drug will also be studied.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01262664

    Sponsor: M.D. Anderson Cancer Center

    Primary Outcome Measures:

    • Measure: Acceptable Dose of Prohibitin-TP01 in Participants with Metastatic Prostate Cancer and Obesity
    • Time Frame: 58 days
    • Safety Issue:
    • Measure: Biologic Activity of Prohibitin-TP01 in Participants with Metastatic Prostate Cancer and Obesity
    • Time Frame: 28 days
    • Safety Issue:

    Estimated Enrollment: 4

    Study Start Date: May 24, 2012

    Phase: Phase 1

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    1. Have histologically confirmed carcinoma of the prostate that is metastatic or otherwise incurable, and a BMI defined as obese (i.e. >30 kg/m2). Any histologic variant is acceptable other than small cell carcinoma.
    2. Have been on androgen deprivation therapy for a minimum of 6 months, and continue that therapy or an equivalent therapy to suppress testosterone during this trial.
    3. Patients with castrate resistant prostate cancer (CRPC) must have no standard options for therapy. Prior to registration on the study, patients with CRPC must be at least 3 weeks from their last treatment, such as ketoconazole, abiraterone, low-dose dexamethasone, anti-androgens, or cytotoxic therapy, (excluding ongoing therapy to suppress testosterone, which must also be continued during this trial).
    4. Have an ECOG performance status 0, 1 or 2
    5. Have adequate bone marrow function defined as an absolute peripheral granulocyte count of >/= 1,000/mm^3 and platelet count of >/= 100,000/mm^3; hemoglobin >/= 8.0 g/dL (without transfusion or growth factor support)
    6. Have adequate hepatic function defined as a total bilirubin of
    7. Have adequate renal function defined as serum creatinine/= 60 mL/min (measured or calculated). In addition, patients must have a 24 hr urine collection showing less than 2000 mg of protein. EXCEPTION: Patients with hematuria will be eligible with up to 3000 mg protein per 24 hours provided they do not have casts, eosinophiluria or electrolyte wasting.
    8. Have adequate cardiovascular function as defined by: i) a normal B-type Natruetic Peptide (BNP) with ii) no signs or symptoms suggestive of cardiac disease and iii) a normal ECG. If these criteria are not met, patients must have an echocardiogram or multigated cardiac scan (MUGA) showing an EF of 45% or greater with no more than "mild" diastolic dysfunction and a BNP of < 200 pg/mL to be eligible.
    9. Sign the current IRB approved informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution

    Exclusion Criteria:

    1. Small cell prostate cancer
    2. Infectious process, which, in the opinion of the investigator, could worsen or its outcome be affected, as a result of the investigational therapy
    3. Any of the following in previous 6 months: NYHA Class III/IV congestive heart failure, unstable angina, cerebrovascular accident (including transient ischemic attack), pulmonary embolism or myocardial infarction (by ECG or serologic criteria)
    4. Significant co-morbidity that could affect the safety or evaluability of participants, specifically including: i) Chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 140 or diastolic pressures above 90 despite therapy. Note that this may be better established with home BP readings than with clinic visit results. Note further that this is NOT a criterion related to particular BP results at the time of assessment for eligibility, nor does it apply to acute BP excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes. The intent is to exclude patients that may have unrecognized renal damage from chronic, uncontrolled hypertension, NOT to exclude patients who may be hypertensive acutely. There are no absolute criteria for BP readings with respect to eligibility (as determined by treating physician).
    5. ( # 9 cont'd) (ii) Uncontrolled diabetes mellitus, defined as: Hgb A1c >8.5%; or symptomatic hypoglycemic episodes > 1 per week during the two months prior to eligibility evaluation; or more than 1 glucose excursion to >300 mg/dL in prior two months--unless clearly iatrogenic and the cause has been eliminated iii) Lung disease requiring supplemental oxygen iv) Known chronic liver disease causing either fibrosis or synthetic dysfunction v) Known HIV infection vi) Overt psychosis, mental disability or being otherwise incompetent to grant informed consent or a history of non-compliance with medical care.
    6. Hydronephrosis (either bilateral or involving a solitary kidney) that has not been addressed by means of a nephrostomy or indwelling stent. EXCEPTION: Non-obstructive hydronephrosis in setting of prior urinary diversion is consistent with eligibility.
    7. Patients require ongoing therapy with non-steroidal anti-inflammatory drugs (NSAIDs), i.v. vancomycin, aminoglycosides, or other potently nephrotoxic drugs, and must agree to abstain from NSAIDs from the time the consent is signed up until 30 days after the last dose of study drug is received, other than low-dose aspirin (81 mg/day or less).
    8. Any other medical condition that in the opinion of the principal investigator would compromise the ability to deliver or evaluate study drug.
    9. Unwillingness to maintain adequate contraception measures for the entire course of the study
    10. Age < 18 years.

    Location:

    • University of Texas MD Anderson Cancer Center
    • Houston Texas 77030 United States

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • A Multi-centre, Prospective, Observational Study on Effectiveness and Safety of ZOLADEX® (Goserelin Acetate Implant) 10.8 mg and ZOLADEX® (Goserelin Acetate Implant) 3.6 mg in Chinese Patients With Localized or Locally Advanced Hormonal Treatment -naïve P

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    A Multi-centre, Prospective, Observational Study on Effectiveness and Safety of ZOLADEX® (Goserelin Acetate Implant) 10.8 mg and ZOLADEX® (Goserelin Acetate Implant) 3.6 mg in Chinese Patients With Localized or Locally Advanced Hormonal Treatment -naïve Prostate Cancer


    Condition: Localized or Locally Advanced Prostate Cancer

    Purpose: This study is a multi-centre, prospective observational study. The study plans to enrol 500 patients with localized or locally advanced prostate cancer who are eligible and intended to be prescribed Zoladex® (goserelin acetate implant) 10.8 mg or Zoladex® (goserelin acetate implant) 3.6 mg as monotherapy or in combination with androgen blockade (CAB) at 50 clinical sites in China. The effectiveness and safety data will be collected at baseline and each visit within 26 weeks after treatment of Zoladex®.

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT03193060

    Sponsor: AstraZeneca

    Primary Outcome Measures:

    • Measure: PSA level
    • Time Frame: each visit within 26 weeks during treatment
    • Safety Issue:
    • Measure: Serum Testosterone
    • Time Frame: each visit within 26 weeks during treatment
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Mean serum Testosterone level
    • Time Frame: each visit within 26 weeks during treatment
    • Safety Issue:
    • Measure: Mean serum PSA level
    • Time Frame: each visit within 26 weeks during treatment
    • Safety Issue:
    • Measure: Number of patients with serum Testosterone less than 50 ng/ml
    • Time Frame: each visit within 26 weeks during treatment
    • Safety Issue:
    • Measure: Incidence of Adverse Events (AEs)
    • Time Frame: each visit within 26 weeks during treatment
    • Safety Issue:
    • Measure: Incidence of AESI (cardiovascular related AE, sexual related AE)
    • Time Frame: each visit within 26 weeks during treatment
    • Safety Issue:
    • Measure: Incidence of Adverse Drug Reactions (ADRs)
    • Time Frame: each visit within 26 weeks during treatment
    • Safety Issue:
    • Measure: Incidence of AEs leading to treatment discontinuation
    • Time Frame: each visit within 26 weeks during treatment
    • Safety Issue:
    • Measure: Proportion of patients with serum Testosterone less than 50 ng/ml
    • Time Frame: each visit within 26 weeks during treatment
    • Safety Issue:
    • Measure: Incidence of Serious Adverse Events (SAEs)
    • Time Frame: each visit within 26 weeks during treatment
    • Safety Issue:

    Estimated Enrollment: 500

    Study Start Date: September 19, 2017

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    Eligibility:

    • Age: minimum 18 Years maximum 100 Years
    • Gender: Male

    Inclusion Criteria:

    1. Ability to provide informed consent, complete all study assessments and have complete medical record;
    2. Male aged 18 years and over;
    3. Diagnosis of localized or locally advanced prostate cancer requiring immediate hormonal therapy;
    4. Being prescribed Zoladex ® (goserelin acetate implant) 10.8 mg or Zoladex ® (goserelin acetate implant) 3.6 mg in accordance with the terms of marketing authorization as monotherapy or in combination with androgen blockade (CAB);
    5. More than 26 weeks' life expectancy;

    Exclusion Criteria:

    1. Patients who are planned to receive radiation therapy;
    2. Patients with hypersensitivity to LHRH, its analogues, or any components of goserelin depot;
    3. Previous or concurrent hormonal therapy including surgical castration, androgen blockers, oestrogen therapy, or other LHRH agonists.

    Contact:

    • AstraZeneca Clinical Study Information Center
    • 1-877-240-9479

    Locations:

    • Research Site
    • Beijing Beijing China
    • Research Site
    • Guangzhou Guangdong China
    • Research Site
    • Huizhou Guangdong China
    • Research Site
    • Jiangmen Guangdong China
    • Research Site
    • Meizhou Guangdong China
    • Research Site
    • Zhuhai Guangdong China
    • Research Site
    • Shi Jiazhuang He Bei China
    • Research Site
    • Langfang Hebei China
    • Research Site
    • Harbin Heilongjiang China
    • Research Site
    • Zhengzhou Henan China
    • Research Site
    • Wuhan Hubei China
    • Research Site
    • Wuhan Hubei China
    • Research Site
    • Baotou Inner Mongolia China
    • Research Site
    • Nanjing Jiangsu China
    • Research Site
    • Yinchuan Ningxia China
    • Research Site
    • Jinan Shandong China
    • Research Site
    • Yantai Shandong China
    • Research Site
    • Shanghai Shanghai China
    • Research Site
    • Xi'an Shanxi China
    • Research Site
    • Chengdu Sichuan China
    • Research Site
    • Urumqi Xinjiang China
    • Research Site
    • Hangzhou Zhejiang China
    • Research Site
    • Jiaxing Zhejiang China
    • Research Site
    • Ningbo Zhejiang China

    View trial on ClinicalTrials.gov


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    Published October 16, 2017
  • A Multicenter, Prospective, Longitudinal Registry of Patients With Prostate Cancer in Asia

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    A Multicenter, Prospective, Longitudinal Registry of Patients With Prostate Cancer in Asia


    Condition: Prostatic Neoplasms

    Intervention:

    • Other: No Intervention

    Purpose: The purpose of this study is to document prostate cancer (PC) management including diagnosis, prognosis, treatment, and care in real-world practice.

    Study Type: Observational [Patient Registry]

    Clinical Trials Identifier NCT 8-digits: NCT02546908

    Sponsor: Janssen Research & Development, LLC

    Primary Outcome Measures:

    • Measure: Overall Survival (OS)
    • Time Frame: up to 5 years
    • Safety Issue:
    • Measure: Prostate Cancer (PC)-related Mortality (PM)
    • Time Frame: up to 5 years
    • Safety Issue:
    • Measure: Metastasis-free survival (MFS)
    • Time Frame: up to 5 years
    • Safety Issue:
    • Measure: Progression-free Survival (PFS)
    • Time Frame: up to 5 years
    • Safety Issue:
    • Measure: Time to Prostate-specific Antigen (PSA) Progression (TTPP)
    • Time Frame: up to 5 years
    • Safety Issue:
    • Measure: European Quality of Life-5 Dimensions, 5 Levels (EQ-5D-5L) Score
    • Time Frame: up to 5 years
    • Safety Issue:
    • Measure: Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) Score
    • Time Frame: up to 5 years
    • Safety Issue:

    Estimated Enrollment: 3830

    Study Start Date: September 9, 2015

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    Eligibility:

    • Age: minimum 21 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Male aged 21 years or older
    • Documented diagnosis of PC with either: High-risk localized PC; Non-metastatic, biochemically recurrent PC; Metastatic PC
    • Signed participation agreement/Informed Consent Form (ICF) by the patient or a legally acceptable representative
    • Agree to be followed-up for PC per routine clinical care Exclusion Criteria:
    • No specific

    Exclusion Criteria:

    • No specific exclusion criteria's were defined

    Contact:

    • Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

    Locations:

    • Beijng University 1st Hospital
    • Beijing 100034 China
    • Beijing Hospital
    • Beijing 100730 China
    • Cancer Hospital, Chinese Academy of Medical Sciences
    • Beijing China
    • the 3rd Affiliated Hospital,Sun Yansen University
    • Guangzhou 510630 China
    • 1st Affliated Hospital of Zhejiang University Medical College
    • Hangzhou 310003 China
    • Fudan University Shanghai Cancer Center
    • Shanghai 200032 China
    • Huadong Hospital Affiliated to Fudan University
    • Shanghai 200400 China
    • The first hospital of China medical university
    • Shenyang 110001 China
    • West China Medical Center of Sichuan University
    • Sichuan 610041 China
    • The Second Affiliatted Hospital of Soochow University
    • Su Zhou 210009 China
    • Tongi Hospital, Tongi Medical College, Huazhong University
    • Wuhan 430030 China
    • First Affiliated Hospital, Xi'an Jiaotong University
    • Xi'An 710061 China
    • Healthcare Global (HCG) Hospital
    • Bangalore 560027 India
    • Rajiv Gandhi Cancer Institute & Research Centre
    • Delhi 110085 India
    • Medanta The Medicity
    • Gurgaon 122001 India
    • Tata Memorial Hospital
    • Mumbai 400012 India
    • P.D. Hinduja National Hospital and - Medical Research Center
    • Mumbai 400016 India
    • All India Institute of Medical Sciences
    • New Delhi 110029 India
    • Chiba Cancer Center
    • Chiba 260-8717 Japan
    • Hirosaki University School of Medicine & Hospital
    • Hirosaki 036-8563 Japan
    • Nara Hospital Kinki University Faculty of Medicine
    • Ikoma 630-0293 Japan
    • Kobe University Hospital
    • Kobe 650-0017 Japan
    • Dokkyo Medical University Koshigaya Hospital
    • Koshigaya 343-8555 Japan
    • NHO Shikoku Cancer Center
    • Matsuyama 791-0280 Japan
    • Kindai University Hospital
    • Osaka-Sayama 589-8511 Japan
    • Osaka University Hospital
    • Suita 565-0871 Japan
    • Seoul National University Hospital
    • Seoul 03080 Korea, Republic of
    • Asan Medical Center
    • Seoul 05505 Korea, Republic of
    • Samsung Medical Center
    • Seoul 06351 Korea, Republic of
    • Gangnam Severance Hospital
    • Seoul 135-720 Korea, Republic of
    • The Catholic University of Korea, Seoul St. Mary's Hospital
    • Seoul 137-701 Korea, Republic of
    • Hospital Kuala Lumpur
    • Kuala Lumpur N/A 50586 Malaysia
    • University Malaya Medical Centre
    • Kuala Lumpur 59100 Malaysia
    • Hospital Umum Sarawak
    • Kuching 93586 Malaysia
    • Hospital Pulau Pinang
    • Pulau Pinang 10990 Malaysia
    • National University Hospital
    • Singapore 119074 Singapore
    • Singapore General Hospital
    • Singapore 169608 Singapore
    • National Cancer Centre
    • Singapore 169610 Singapore
    • Tan Tock Seng Hospital
    • Singapore 308433 Singapore
    • Kaohsiung Veterans General Hospital
    • Kaohsiung Taiwan
    • China Medical University Hospital
    • Taichung 403 Taiwan
    • National Cheng Kung University Hospital
    • Tainan 70403 Taiwan
    • National Taiwan University Hospital.
    • Taipei 10002 Taiwan
    • Taipei Veterans General Hospital
    • Taipei 11217 Taiwan
    • King Chulalongkorn Memorial Hospital
    • Bangkok 10330 Thailand
    • Siriraj Hospital
    • Bangkok 10700 Thailand
    • Maharaj Nakorn Chiangmai Hospital
    • Chiang Mai 50200 Thailand
    • Songkhla Hospital
    • Songkla 90110 Thailand

    View trial on ClinicalTrials.gov


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    Published January 12, 2017
  • A Multinational, Phase 3, Randomized, Double Blind, Placebo Controlled, Efficacy and Safety Study of Enzalutamide in Patients With Nonmetastatic Castration Resistant Prostate Cancer

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    A Multinational, Phase 3, Randomized, Double Blind, Placebo Controlled, Efficacy and Safety Study of Enzalutamide in Patients With Nonmetastatic Castration Resistant Prostate Cancer


    Condition: Nonmetastatic Castration-Resistant Prostate Cancer, Prostate Cancer, Cancer of the Prostate

    Intervention:

    • Drug: Enzalutamide
    • Drug: Placebo

    Purpose: The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02003924

    Sponsor: Pfizer

    Primary Outcome Measures:

    • Measure: Metastasis Free Survival (MFS)
    • Time Frame: ≥ 16 weeks
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Time to Prostate-Specific Antigen (PSA) Progression
    • Time Frame: ≥ 16 weeks
    • Safety Issue:
    • Measure: Time to First Use of New Antineoplastic Therapy
    • Time Frame: ≥ 16 weeks
    • Safety Issue:
    • Measure: Overall Survival (OS)
    • Time Frame: ≥ 16 weeks
    • Safety Issue:
    • Measure: Time to First Use of Cytotoxic Chemotherapy
    • Time Frame: ≥ 16 weeks
    • Safety Issue:
    • Measure: FACT-P Global Score
    • Time Frame: ≥ 16 weeks
    • Safety Issue:
    • Measure: Quality of Life as assessed by EQ-5D-5L and QLQ-PR25
    • Time Frame: ≥ 16 weeks
    • Safety Issue:
    • Measure: Time to chemotherapy-free disease specific survival
    • Time Frame: ≥ 16 weeks
    • Safety Issue:
    • Measure: Time to chemotherapy-free survival
    • Time Frame: ≥ 16 weeks
    • Safety Issue:
    • Measure: Time to pain progression
    • Time Frame: ≥ 16 weeks
    • Safety Issue:
    • Measure: Safety as assessed by percentage of patients with any Adverse Event (AE), AE leading to Study Drug Discontinuation, AE leading to death, Serious Adverse Event (SAE), AE related to study drug, SAE related to study drug
    • Time Frame: ≥ 16 weeks
    • Safety Issue:
    • Measure: PSA response rates
    • Time Frame: ≥ 16 weeks
    • Safety Issue:

    Estimated Enrollment: 1440

    Study Start Date: December 2013

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;
    • Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);
    • Testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening;
    • Progressive disease on androgen deprivation therapy at enrollment;
    • PSA and the screening PSA assessed by the central laboratory (central PSA) should be ≥ 2 µg/L (2 ng/mL:
    • PSA doubling time ≤ 10 months;
    • No prior or present evidence of metastatic disease;
    • Asymptomatic prostate cancer;
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
    • Estimated life expectancy ≥ 12 months.

    Exclusion Criteria:

    • Prior cytotoxic chemotherapy;
    • Use of hormonal therapy or biologic therapy for prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist therapy) or use of an investigational agent within 4 weeks of randomization;
    • Known or suspected brain metastasis or active leptomeningeal disease;
    • History of another invasive cancer within 3 years of randomization;
    • Absolute neutrophil count < 1000/μL, platelet count < 100,000/μL, or hemoglobin < 10 g/dL (6.2 mmol/L) at screening;
    • Total bilirubin ≥ 1.5 times the upper limit of normal;
    • Creatinine > 2 mg/dL (177 µmol/L) at screening;
    • Albumin < 3.0 g/dL (30 g/L) at screening;
    • History of seizure or any condition that may predispose to seizure;
    • Clinically significant cardiovascular disease;
    • Gastrointestinal disorder affecting absorption;
    • Major surgery within 4 weeks of randomization;
    • Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;
    • Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.

    Contact:

    • Pfizer CT.gov Call Center
    • 1-800-718-1021

    Locations:

    • Tucson Arizona 87541 United States
    • Los Angeles California 90095 United States
    • Orange California 92868 United States
    • Englewood Colorado 80113 United States
    • New Haven Connecticut 06520 United States
    • Lakeland Florida 33805 United States
    • Indianapolis Indiana 46202 United States
    • Jeffersonville Indiana 47130 United States
    • Lafayette Indiana 47904 United States
    • Lenexa Kansas 66214 United States
    • Wichita Kansas 67226 United States
    • Baltimore Maryland 21229 United States
    • Ann Arbor Michigan 48109 United States
    • Troy Michigan 48084 United States
    • Omaha Nebraska 68130 United States
    • Brooklyn New York 11215 United States
    • Newburgh New York 12550 United States
    • Gastonia North Carolina 28054 United States
    • Raleigh North Carolina 27607 United States
    • Middleburg Heights Ohio 44130 United States
    • Springfield Oregon 97477 United States
    • Lancaster Pennsylvania 17604 United States
    • Myrtle Beach South Carolina 29572 United States
    • Nashville Tennessee 37232 United States
    • San Antonio Texas 78229 United States
    • Virginia Beach Virginia 23462 United States
    • Berazategui Buenos Aires B1880BBF Argentina
    • Rosario Santa Fe 2000 Argentina
    • Buenos Aires C1019ABS Argentina
    • Caba C1181ACH Argentina
    • Ciudada Autonoma de Buenos Aires C1120AAT Argentina
    • Cordoba 5016 Argentina
    • Cordoba X5004FHP Argentina
    • La Rioja F5300COE Argentina
    • Santa Fe S2000KZE Argentina
    • Garran Australian Capital Territory 2605 Australia
    • Concord New South Wales 2139 Australia
    • Lismore New South Wales 2480 Australia
    • New Lambton Heights New South Wales 2305 Australia
    • North Ride New South Wales 2109 Australia
    • Port Macquarie New South Wales 2444 Australia
    • St Leonards New South Wales 2065 Australia
    • Tweed Heads New South Wales 2485 Australia
    • Wahroonga New South Wales 2076 Australia
    • Waratah New South Wales 2298 Australia
    • Westmead New South Wales 2145 Australia
    • South Brisbane Queensland 4101 Australia
    • Southport Queensland 4215 Australia
    • Woolloongabb Queensland 4102 Australia
    • Kurralta Park South Australia 5037 Australia
    • Bentleigh East Victoria 3165 Australia
    • Box Hill Victoria 3128 Australia
    • East Melbourne Victoria 3002 Australia
    • Footscray Victoria 3011 Australia
    • Heidelberg Victoria 3084 Australia
    • Malvern Victoria 3144 Australia
    • Wodonga Victoria 3690 Australia
    • Roeselare 8800 Australia
    • Linz 4010 Austria
    • Vienna 1090 Austria
    • Vienna 1170 Austria
    • Bruxelles 1070 Belgium
    • Bruxelles 1200 Belgium
    • Gent 9000 Belgium
    • Kortrijk 8500 Belgium
    • Leuven 3000 Belgium
    • Liege 4000 Belgium
    • Mons 7000 Belgium
    • Salvador Bahia 41253 Brazil
    • Curtiba Parana 81520-060 Brazil
    • Ljui Rio Grande do Sul 98700-000 Brazil
    • Passo Fundo Rio Grande do Sul 99074-450 Brazil
    • Porto Alegre Rio Grande do Sul 90035-074 Brazil
    • Porto Alegre Rio Grande do Sul 90035-903 Brazil
    • Campinas Sao Paulo 13083-888 Brazil
    • Santo Andre Sao Paulo 09060-650 Brazil
    • Rio de Janeiro 20551-030 Brazil
    • Rio de Janiero 22260-020 Brazil
    • Sao Paulo 05652-900 Brazil
    • Sao Paulo 17210-120 Brazil
    • Calgary Alberta T2S 3C3 Canada
    • Edmonton Alberta T6G 1Z2 Canada
    • Vancouver British Columbia V5Z 1M9 Canada
    • Winnipeg Manitoba R3E 0V9 Canada
    • Halifax Nova Scotia B3H2Y9 Canada
    • Barrie Ontario L4M 7G1 Canada
    • Hamilton Ontario L8N 4A6 Canada
    • Kitchener Ontario N2N 2B9 Canada
    • London Ontario N6A 4L6 Canada
    • Toronto Ontario M4N 3M5 Canada
    • Toronto Ontario M5G 2M9 Canada
    • Greenfield Park Quebec J4V 2H3 Canada
    • Montreal Quebec H2L 4M1 Canada
    • Montreal Quebec H3G 1A4 Canada
    • Québec City G1R 2J6 Canada
    • Talcahuano Concepcion 4270918 Chile
    • Santiago 7500921 Chile
    • Santiago 7630370 Chile
    • Temunco 4810469 Chile
    • Vina del Mar 2540364 Chile
    • Beijing Beijing 100034 China
    • Beijing Beijing 100142 China
    • Beijing Beijing 100191 China
    • Nanjing Jiangsu 210009 China
    • Suzhou City Jiangsu 215004 China
    • Wuxi Jiangsu 214023 China
    • Shanghai Shanghai 200032 China
    • Shanghai Shanghai 200040 China
    • Shanghai Shanghai 200080 China
    • Shanghai Shanghai 200092 China
    • Xi'an Shanxi 710061 China
    • Tianjin Tianjin 300211 China
    • Hangzhou Zhejiang 310009 China
    • Wenzhou Zhejiang 325000 China
    • Beijing 100032 China
    • Beijing 100730 China
    • Chongqing 400030 China
    • Guangdong 510150 China
    • Guangzhou 510120 China
    • Nanjing 210008 China
    • Nanjing 210029 China
    • Wuhan 430071 China
    • Copenhagen 2200 N Denmark
    • Frederiksberg 2000 Denmark
    • Herlev 2730 Denmark
    • Odense 5000 Denmark
    • Århus 8200 Denmark
    • Helsinki 180 Finland
    • Helsinki 290 Finland
    • Oulu 90220 Finland
    • Pori 28500 Finland
    • Tampere 33520 Finland
    • Strasbourg Bas-Rhin 67000 France
    • Bordeaux Cedex Gironde 33076 France
    • Toulouse Cedex Haute Garonne 31052 France
    • Toulouse Haute Garonne 31076 France
    • Saint Herblain Loire Atlantique 44805 France
    • Lille Cedex Nord 59037 France
    • Lyon Rhone 69437 France
    • Pierre Benite Cedex Rhone 69495 France
    • Strasbourg Rhone 67091 France
    • Le Mans Sarthe 72000 France
    • Rouen Upper Normandy 76000 France
    • Villejuif Cedex Val de Marne 94805 France
    • Poitiers Vienne 86021 France
    • Angers Cedex 9 49933 France
    • Avignon 84918 France
    • Brest 29609 France
    • Dijon 2100 France
    • Limoges 87042 France
    • Lyon Cedex 69003 France
    • Lyon 69009 France
    • Montpellier 34298 France
    • Paris Cedex 15 75908 France
    • Paris 75248 France
    • Vandoeuvre les Nancy 54511 France
    • Nuertingen Baden-Württemberg 72622 Germany
    • Tubingen Baden-Württemberg 72076 Germany
    • Weiden Bavaria 92637 Germany
    • Braunschweig Lower Saxony 38126 Germany
    • Leer Niedersachsen 26789 Germany
    • Dresden Saxony 1307 Germany
    • Berlin 12200 Germany
    • Hamburg 20246 Germany
    • Athens 11526 Greece
    • Athens 11528 Greece
    • Crete 71201 Greece
    • Larisa 41110 Greece
    • Thessaloniki 56403 Greece
    • Hong Kong Hong Kong
    • Pokfulam Hong Kong
    • Belfast BT9 7AB Ireland
    • Cremona 26100 Italy
    • Meldola (FC) 47104 Italy
    • Milano 20133 Italy
    • Milano 20141 Italy
    • Modena 41124 Italy
    • Orbassano 10043 Italy
    • Padova 35128 Italy
    • Ravenna 48121 Italy
    • Roma 152 Italy
    • Trento 38122 Italy
    • Goyang-Si 410-769 Korea, Republic of
    • Hwasun-Gun 519-763 Korea, Republic of
    • Incheon 405-760 Korea, Republic of
    • Seoul 110-744 Korea, Republic of
    • Seoul 120-752 Korea, Republic of
    • Seoul 135-710 Korea, Republic of
    • Seoul 135-720 Korea, Republic of
    • Seoul 138-736 Korea, Republic of
    • Kuching Sarawak 93586 Malaysia
    • Kuala Lampur 59100 Malaysia
    • Amsterdam North Holland 1066cx Netherlands
    • Dordrecht 3318 AT Netherlands
    • Eindhoven 5623 EJ Netherlands
    • Groningen 9713 GZ Netherlands
    • Maastricht 6229 HX Netherlands
    • Christchurch 8011 New Zealand
    • Grafton 1023 New Zealand
    • Hamilton 4144 New Zealand
    • Palmerston North 4144 New Zealand
    • Tauranga 3140 New Zealand
    • Gdansk 80-952 Poland
    • Kielce 25-734 Poland
    • Lublin 20-718 Poland
    • Mielec 39-300 Poland
    • Slupsk 76-200 Poland
    • Wroclaw 51-685 Poland
    • Wroclaw 53-114 Poland
    • Wroclaw Poland
    • Wrocław 50-981 Poland
    • Moscow 115478 Russian Federation
    • Moscow 125284 Russian Federation
    • Republic of Bashkortostan Russian Federation
    • Belgrade 11000 Serbia
    • Belgrade 11040 Serbia
    • Belgrade 11080 Serbia
    • Singapore 119074 Singapore
    • Singapore 169610 Singapore
    • Martin Slovak Republic 036 01 Slovakia
    • Banska Bystrica 97517 Slovakia
    • Bratislava 85105 Slovakia
    • Kosice 4190 Slovakia
    • Nitra 94901 Slovakia
    • Presov 8001 Slovakia
    • Skalica 90980 Slovakia
    • Zilina 1207 Slovakia
    • Palma de Mallorca Baleares 07101 Spain
    • Manresa Barcelona 8243 Spain
    • Sabadell Barcelona 8208 Spain
    • San Sebastian Guipuzcoa/Pais Vasco 20014 Spain
    • Pamplona Navarra 31008 Spain
    • Barcelona 8003 Spain
    • Barcelona 8036 Spain
    • Girona 17007 Spain
    • Madrid 28006 Spain
    • Madrid 28033 Spain
    • Madrid 28041 Spain
    • Santiago 15706 Spain
    • Göteborg 41345 Sweden
    • Malmo 20502 Sweden
    • Orebro 70185 Sweden
    • Stockholm 118 53 Sweden
    • Stockholm 17176 Sweden
    • Umea 90185 Sweden
    • Chiayi County 613 Taiwan
    • Gueishan 333 Taiwan
    • Kaohsiung 80756 Taiwan
    • Kaohsiung 807 Taiwan
    • Kaohsiung 81346 Taiwan
    • Kaohsiung 81362 Taiwan
    • Kaohsiung 830 Taiwan
    • Keelung City 204 Taiwan
    • Taichung 40447 Taiwan
    • Taichung 40705 Taiwan
    • Tainan City 710 Taiwan
    • Tainan 71004 Taiwan
    • Taipei City 11217 Taiwan
    • Taipei 10002 Taiwan
    • Taipei 11217 Taiwan
    • Taipei 22060 Taiwan
    • Bangkok 10330 Thailand
    • Bangkok 10400 Thailand
    • Hat Yai 90110 Thailand
    • Muang 50200 Thailand
    • Adana 01380 Turkey
    • Ankara 06600 Turkey
    • Istanbul 34098 Turkey
    • Izmir 35110 Turkey
    • Manisa 45030 Turkey
    • Chernivtsi 58002 Ukraine
    • Dnipropetrovsk 49005 Ukraine
    • Kharkiv 61037 Ukraine
    • Kyiv 02125 Ukraine
    • Uzhgorod 88000 Ukraine
    • Zaporizhzhia 69600 Ukraine
    • Cambridge Cambridgeshire CB2 0QQ United Kingdom
    • London Greater London NW1 2BU United Kingdom
    • Manchester Greater Manchester M20 4BX United Kingdom
    • Oxford Oxfordshire OX3 7LJ United Kingdom
    • Sutton Surrey SM2 5PT United Kingdom
    • Newcastle Tyne & Wear NE7 7DN United Kingdom
    • Birmingham B15 2TH United Kingdom
    • Brighton BN2 5BE United Kingdom
    • Bristol BS2 8ED United Kingdom
    • London SW3 6JJ United Kingdom
    • London W12 0NN United Kingdom

    View trial on ClinicalTrials.gov


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    Published March 6, 2017
  • A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of BAY1841788 (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer

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    A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of BAY1841788 (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer


    Condition: Prostate Cancer Non-Metastatic, Castration-Resistant

    Intervention:

    • Drug: BAY1841788 (ODM-201)
    • Drug: Placebo

    Purpose: The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02200614

    Sponsor: Bayer

    Primary Outcome Measures:

    • Measure: Metastasis-Free Survival
    • Time Frame: Up to 72 months
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Overall Survival
    • Time Frame: Up to 72 months
    • Safety Issue:
    • Measure: Time to first symptomatic skeletal event (SSE)
    • Time Frame: Up to 72 months
    • Safety Issue:
    • Measure: Time to initiation of first cytotoxic chemotherapy for prostate cancer
    • Time Frame: Up to 72 months
    • Safety Issue:
    • Measure: Time to pain progression
    • Time Frame: Up to 72 months
    • Safety Issue:
    • Measure: Safety and tolerability of ODM-201
    • Time Frame: Up to 72 months
    • Safety Issue:

    Estimated Enrollment: 1500

    Study Start Date: September 12, 2014

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.
    • Castration-resistant prostate cancer (CRPC) with castrate level of serum testosterone.
    • Prostate-specific antigen doubling time of ≤ 10 months and PSA > 2ng/ml.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
    • Blood counts at screening: haemoglobin ≥ 9.0 g/dl,absolute neutrophil count ≥ 1500/µl, platelet count ≥ 100,000/µl.
    • Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, creatinine ≤ 2.0 x ULN.
    • Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 3 months after the end of the study treatment.

    Exclusion Criteria:

    • History of metastatic disease at any time or presence of detectable metastases.
    • Acute toxicities of prior treatments and procedures not resolved to grade ≤ 1 or baseline before randomisation.
    • Prior treatment with: second generation androgen receptor (AR) inhibitors, other investigational AR inhibitors, or CYP17 enzyme inhibitor.
    • Use of estrogens or 5-α reductase inhibitors or AR inhibitors.
    • Prior chemotherapy or immunotherapy for prostate cancer.
    • Use of systemic corticosteroid.
    • Radiation therapy within 12 weeks before randomisation.
    • Severe or uncontrolled concurrent disease, infection or co-morbidity.
    • Treatment with bisphosphonate or denosumab within 12 weeks before randomisation.
    • Known hypersensitivity to the study treatment or any of its ingredients.
    • Major surgery within 28 days before randomisation.
    • Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.
    • Uncontrolled hypertension.
    • Prior malignancy.
    • Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment.
    • Active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease.
    • Treatment with any investigational drug within 28 days before randomisation.
    • Any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures.

    Contact:

    • Bayer Clinical Trials Contact
    • +49 30 300139003

    Locations:

    • Homewood Alabama 35209 United States
      Anchorage Alaska 99503 United States
      Tucson Arizona 85704 United States
      Fountain Valley California 92708 United States
      La Jolla California 92093 United States
      Laguna Hills California 92653 United States
      Los Angeles California 90048 United States
      Los Angeles California 90073-1003 United States
      Orange California 92868 United States
      San Diego California 92120 United States
      Whittier California 90603 United States
      Denver Colorado 80211 United States
      Denver Colorado 80220 United States
      Parker Colorado 80134 United States
      Boca Raton Florida 33486 United States
      Miami Gardens Florida 33169 United States
      Orlando Florida 32803 United States
      Port Saint Lucie Florida 34952 United States
      Coeur d'Alene Idaho 83814 United States
      Chicago Illinois 60612 United States
      Evanston Illinois 60201-1613 United States
      Springfield Illinois 62704 United States
      Greenwood Indiana 46143 United States
      Indianapolis Indiana 46202 United States
      Jeffersonville Indiana 47130 United States
      West Des Moines Iowa 50266 United States
      Wichita Kansas 67226 United States
      New Orleans Louisiana 70121 United States
      Annapolis Maryland 21401 United States
      Baltimore Maryland 21201 United States
      Baltimore Maryland 21204 United States
      Salisbury Maryland 21801 United States
      Boston Massachusetts 02114 United States
      Farmington Hills Michigan 48334 United States
      Grand Rapids Michigan 49546 United States
      Royal Oak Michigan 48073 United States
      Woodbury Minnesota 55125 United States
      Omaha Nebraska 68114 United States
      Omaha Nebraska 68130 United States
      Lebanon New Hampshire 03756-0001 United States
      Edison New Jersey 08837 United States
      Englewood New Jersey 07631 United States
      Lawrenceville New Jersey 08648 United States
      Voorhees New Jersey 08043 United States
      Bronx New York 10461 United States
      Bronx New York 10469 United States
      Brooklyn New York 11215 United States
      New York New York 10016 United States
      Syracuse New York 13210 United States
      Asheboro North Carolina 27203 United States
      Durham North Carolina 27705 United States
      Gastonia North Carolina 28054 United States
      Canton Ohio 44718 United States
      Cincinnati Ohio 45212-1979 United States
      Cleveland Ohio 44195 United States
      Gahanna Ohio 43230 United States
      Middleburg Heights Ohio 44130 United States
      Oklahoma City Oklahoma 73104 United States
      Bala-Cynwyd Pennsylvania 19004 United States
      Bryn Mawr Pennsylvania 19010 United States
      Warwick Rhode Island 02886 United States
      Charleston South Carolina 29407 United States
      Myrtle Beach South Carolina 29572 United States
      Nashville Tennessee 37209 United States
      Dallas Texas 75231 United States
      Houston Texas 77027 United States
      Houston Texas 77030 United States
      San Antonio Texas 78240 United States
      Falls Church Virginia 22031 United States
      Richmond Virginia 23235 United States
      Virginia Beach Virginia 23462 United States
      Wheeling West Virginia 26003 United States
      Buenos Aires Ciudad Auton. De Buenos Aires C1120AAT Argentina
      Rosario Santa Fe S2000KZE Argentina
      Santa Fé Santa Fe S3000FFV Argentina
      San Miguel de Tucumán Tucuman T4000GTB Argentina
      San Miguel de Tucumán Tucuman T4000HXU Argentina
      Córdoba 5000 Argentina
      Córdoba X5000HXL Argentina
      Córdoba X5016KEH Argentina
      La Rioja 5300 Argentina
      Randwick New South Wales 2031 Australia
      St Leonards New South Wales 2065 Australia
      Waratah New South Wales 2298 Australia
      Douglas Queensland 4814 Australia
      South Brisbane Queensland 4101 Australia
      Fitzroy Victoria 3065 Australia
      Richmond Victoria 3122 Australia

      Kurralta Park 5037 Australia

      Linz Oberösterreich 4020 Austria

      Wels Oberösterreich 4600 Austria

      Wien 1020 Austria

      Wien 1090 Austria

      Brest 223041 Belarus

      Lesnoy 223040 Belarus

      Minsk 220013 Belarus

      Minsk 220114 Belarus

      Minsk 223041 Belarus

      Bonheiden 2820 Belgium

      Kortrijk 8500 Belgium

      Leuven 3000 Belgium

      Libramont 6800 Belgium

      Liege 4000 Belgium

      Sint-truiden 3800 Belgium

      Wilrijk 2610 Belgium

      Salvador-Bahia Bahia 40050410 Brazil

      Fortaleza Ceará 60430-230 Brazil

      Goiânia Goiás 74605-180 Brazil

      Belo Horizonte Minas Gerais 30150-270 Brazil

      Belo Horizonte Minas Gerais 30150-320 Brazil

      Juiz de Fora Minas Gerais 36010-510 Brazil

      Uberlandia Minas Gerais 38408-150 Brazil

      Curitiba Parana 81520-060 Brazil

      Recife Pernambuco 50070-550 Brazil

      Passo Fundo Rio Grande Do Sul 99010-260 Brazil

      Porto Alegre Rio Grande Do Sul 90050 170 Brazil

      Porto Alegre Rio Grande Do Sul 90610-000 Brazil

      Porto Alegre Rio Grande Do Sul Brazil

      Itajaí Santa Catarina 88301-220 Brazil

      Barretos Sao Paulo 14784400 Brazil

      Jau Sao Paulo 17210-080 Brazil

      Ribeirao Preto - SP Sao Paulo 14048-900 Brazil

      Sorocaba Sao Paulo 18035-300 Brazil

      São Paulo Sao Paulo 01209-000 Brazil

      São Paulo Sao Paulo 01236-030 Brazil

      São Paulo Sao Paulo 01246-000 Brazil

      São Paulo Sao Paulo 03102 002 Brazil

      São Paulo Sao Paulo 04039-004 Brazil

      Rio de Janeiro 20551-030 Brazil

      Plovdiv 4000 Bulgaria

      Sofia 1606 Bulgaria

      Sofia 1680 Bulgaria

      Varna 9000 Bulgaria

      Calgary Alberta T2V 1P9 Canada

      Victoria British Columbia V8T 2C1 Canada

      Halifax Nova Scotia B3H 2Y9 Canada

      Barrie Ontario L4M 7G1 Canada

      Burlington Ontario L7N 3V2 Canada

      Hamilton Ontario L8N 4A6 Canada

      Kingston Ontario K7L 3J7 Canada

      London Ontario N6A 5W9 Canada

      Toronto Ontario M4N 3M5 Canada

      Toronto Ontario M5G 2M9 Canada

      Granby Quebec J2G 8Z9 Canada

      Pointe-Claire Quebec H9R 4S3 Canada

      Medellín Antioquia Colombia

      Montería Córdoba Colombia

      Bucaramanga Santander Colombia

      Hradec Kralove 500 05 Czechia

      Jablonec nad Nisou 466 60 Czechia

      Karlovy Vary 360 66 Czechia

      Kolin 280 00 Czechia

      Olomouc 775 20 Czechia

      Opava 746 01 Czechia

      Praha 10 10034 Czechia

      Praha 2 120 00 Czechia

      Praha 2 12808 Czechia

      Praha 5 150 06 Czechia

      Praha 6 160 00 Czechia

      Praha 8 180 81 Czechia

      Tallinn 10138 Estonia

      Tallinn 13419 Estonia

      Tallinn 13912 Estonia

      Tartu 51014 Estonia

      HUS 00029 Finland

      KYS 70029 Finland

      Seinäjoki 60220 Finland

      Tampere Finland

      Turku FIN-20521 Finland

      Angers 49933 France

      Bayonne 64100 France

      Besancon 25030 France

      Bordeaux 33076 France

      CAEN cedex 05 14076 France

      Clermont Ferrand Cedex 1 63011 France

      Creteil 94010 France

      Dijon 21000 France

      La Roche Sur Yon Cedex 85025 France

      Limoges Cedex 87042 France

      Montpellier Cedex 34298 France

      Montpellier 34000 France

      Montpellier 34070 France

      Nancy 54100 France

      Nantes Cedex 44093 France

      Nice Cedex 2 06102 France

      Paris 75010 France

      Paris 75014 France

      Paris 75014 France

      Paris 75020 France

      Pierre Benite 69495 France

      Poitiers Cedex 86021 France

      Pontoise 95301 France

      Quimper 29000 France

      Reims 51056 France

      Rennes Cedex 35033 France

      Rouen Cedex 76031 France

      Saint Mande 94160 France

      Strasbourg 67000 France

      Suresnes 92151 France

      Tours 37044 France

      Villejuif Cedex 94805 France

      Emmendingen Baden-Württemberg 79312 Germany

      Heidelberg Baden-Württemberg 69115 Germany

      Kirchheim unter Teck Baden-Württemberg 73230 Germany

      Mühlacker Baden-Württemberg 75417 Germany

      Reutlingen Baden-Württemberg 72764 Germany

      Tübingen Baden-Württemberg 72076 Germany

      Waldshut-Tiengen Baden-Württemberg 79761 Germany

      Nürnberg Bayern 90489 Germany

      Planegg Bayern 82152 Germany

      Frankfurt Hessen 60590 Germany

      Marburg Hessen 35039 Germany

      Hagenow Mecklenburg-Vorpommern 19230 Germany

      Rostock Mecklenburg-Vorpommern 18107 Germany

      Hannover Niedersachsen 30625 Germany

      Herzberg Am Harz Niedersachsen 37412 Germany

      Holzminden Niedersachsen 37603 Germany

      Osnabrück Niedersachsen 49076 Germany

      Düsseldorf Nordrhein-Westfalen 40225 Germany

      Köln Nordrhein-Westfalen 50931 Germany

      Mülheim Nordrhein-Westfalen 45468 Germany

      Münster Nordrhein-Westfalen 48149 Germany

      Wuppertal Nordrhein-Westfalen 42103 Germany

      Mainz Rheinland-Pfalz 55131 Germany

      Homburg Saarland 66421 Germany

      Magdeburg Sachsen-Anhalt 39112 Germany

      Dresden Sachsen 01307 Germany

      Markkleeberg Sachsen 04416 Germany

      Berlin 10115 Germany

      Berlin 12200 Germany

      Hamburg 20246 Germany

      Hamburg 22081 Germany

      Tübingen 72076 Germany

      Abelokipi - Athens 115 26 Greece

      Athens 115 27 Greece

      Athens 11522 Greece

      Athens 11527 Greece

      Athens 11528 Greece

      Glyfada/Athens 16675 Greece

      Ioannina 45500 Greece

      Thessaloniki-Moudanion 57001 Greece

      Budapest 1085 Hungary

      Budapest 1145 Hungary

      Budapest 1204 Hungary

      Debrecen 4032 Hungary

      Gyor 9024 Hungary

      Nyiregyhaza 4400 Hungary

      Szeged 6725 Hungary

      Szekszard 7100 Hungary

      Szolnok 5004 Hungary

      Zalaegerszeg 8900 Hungary

      Beer Sheva 8410101 Israel

      Haifa 3339419 Israel

      Haifa 35152 Israel

      Jerusalem 9103102 Israel

      Nahariya 2210001 Israel

      Ramat Gan 5262000 Israel

      Tel Aviv 6423906 Israel

      Zefat 1311001 Israel

      Chieti Abruzzo 66100 Italy

      Catanzaro Calabria 88100 Italy

      Napoli Campania 80131 Italy

      Napoli Campania Italy

      Bologna Emilia-Romagna 40138 Italy

      Forlì-Cesena Emilia-Romagna 47014 Italy

      Modena Emilia-Romagna 41124 Italy

      Parma Emilia-Romagna 43126 Italy

      Roma Lazio 00144 Italy

      Roma Lazio 00189 Italy

      Como Lombardia Italy

      Milano Lombardia 20159 Italy

      Novara Piemonte 28100 Italy

      Torino Piemonte 10043 Italy

      Torino Piemonte 10060 Italy

      Lecce Puglia 73100 Italy

      Catania Sicilia 95123 Italy

      Messina Sicilia 98125 Italy

      Palermo Sicilia 90127 Italy

      Arezzo Toscana 52100 Italy

      Siena Toscana 53100 Italy

      Nagoya Aichi 466-8560 Japan

      Nagoya Aichi 466-8650 Japan

      Kashiwa Chiba 277-8577 Japan

      Iizuka Fukuoka 820-8505 Japan

      Kurume Fukuoka 839-0863 Japan

      Koriyama Fukushima 963-8052 Japan

      Maebashi Gunma 371-8511 Japan

      Otake Hiroshima 739-0696 Japan

      Sapporo Hokkaido 060-8543 Japan

      Kobe Hyogo 650-0047 Japan

      Higashiibaraki Ibaraki 311-3193 Japan

      Kahoku-gun Ishikawa 920-0293 Japan

      Kanazawa Ishikawa 920-8530 Japan

      Sagamihara Kanagawa 252-0375 Japan

      Yokohama Kanagawa 232-0024 Japan

      Yokosuka Kanagawa 238-8558 Japan

      Sendai Miyagi 980-8574 Japan

      Sendai Miyagi 981-8563 Japan

      Ueda Nagano 386-8610 Japan

      Kashihara Nara 634-8522 Japan

      Yufu Oita 879-5593 Japan

      Kurashiki Okayama 710-8602 Japan

      Higashiosaka Osaka 578-8588 Japan

      Osakasayama Osaka 589-8511 Japan

      Takatsuki Osaka 569-1192 Japan

      Wako Saitama 351-0102 Japan

      Hamamatsu Shizuoka 431-3192 Japan

      Sunto Shizuoka 411-8611 Japan
      Utsunomiya Tochigi 321-0974 Japan
      Bunkyo-ku Tokyo 113-8431 Japan
      Bunkyo-ku Tokyo 113-8603 Japan
      Itabashi-ku Tokyo 173-0015 Japan
      Minato-ku Tokyo 105-8471 Japan
      Mitaka Tokyo 181-8611 Japan
      Nakano-ku Tokyo 164-8541 Japan
      Shinjuku-ku Tokyo 160-8582 Japan

      Sumida-ku Tokyo 130-8587 Japan

      Ube Yamaguchi 755-8505 Japan

      Chiba 260-8717 Japan

      Fukui 910-8526 Japan

      Hiroshima 730-8518 Japan

      Kumamoto 861-8520 Japan

      Kyoto 602-8566 Japan

      Nagasaki 852-8501 Japan

      Nagasaki 852-8511 Japan

      Okayama 700-8558 Japan

      Osaka 541-8567 Japan

      Osaka 545-8586 Japan

      Osaka 558-8558 Japan

      Toyama 930-0194 Japan

      Donggu, Gwangju Gwang''yeogsi 501-757 Korea, Republic of

      Seoul Seoul Teugbyeolsi 135-720 Korea, Republic of

      Chungchungbuk-do 361-711 Korea, Republic of

      Daegu 700-701 Korea, Republic of

      Daegu 700-712 Korea, Republic of

      Incheon 405-760 Korea, Republic of

      Seoul 110-744 Korea, Republic of

      Seoul 120-752 Korea, Republic of

      Seoul 135-710 Korea, Republic of

      Seoul 137-701 Korea, Republic of

      Seoul 138-736 Korea, Republic of

      Daugavpils LV5401 Latvia

      Jelgava LV-3001 Latvia

      Leipaja LV-3401 Latvia

      Riga LV-1001 Latvia

      Riga LV-1002 Latvia

      Riga LV-1038 Latvia

      Kaunas LT-50009 Lithuania

      Klaipeda LT-92288 Lithuania

      Vilnius LT-08660 Lithuania

      Vilnius LT-08661 Lithuania

      La Victoria Arequipa Peru

      Lima 27 Peru

      Lima LIMA 11 Peru

      Lima LIMA 18 Peru

      Lima LIMA 27 Peru

      Elblag 82-300 Poland

      Gdansk 80-952 Poland

      Lodz 90-302 Poland

      Lodz 90-549 Poland

      Lublin 20-718 Poland

      Otwock Poland

      Rzeszow 35-922 Poland

      Siedlce 08-110 Poland

      Warszawa 02-005 Poland

      Warszawa 02-507 Poland

      Warszawa 02-616 Poland

      Warszawa 02-781 Poland

      Warszawa 04-125 Poland

      Wroclaw 50-556 Poland

      Wroclaw 54-144 Poland

      Santa Maria da Feira Porto 4520-211 Portugal

      Almada 2801-951 Portugal

      Braga 4710-243 Portugal

      Coimbra 3000-075 Portugal

      Guimaraes 4835-044 Portugal

      Lisboa 1093-023 Portugal

      Lisboa 1150-199 Portugal

      Lisboa 1349-019 Portugal

      Lisboa 1400-038 Portugal

      Lisboa 1500-650 Portugal

      Matosinhos 4464-513 Portugal

      Porto 4200-072 Portugal

      Porto 4200-319 Portugal

      Bucuresti 22328 Romania

      Bucuresti 41345 Romania

      Bucuresti 50659 Romania

      Bucuresti 75000 Romania

      Cluj-Napoca 400015 Romania

      Cluj-Napoca 400132 Romania

      Craiova 200385 Romania

      Craiova 200642 Romania

      Oradea 410159 Romania

      Ploiesti 100337 Romania

      Targu-Mures 540103 Romania

      Arkhangelsk 163045 Russian Federation

      Barnaul 656049 Russian Federation

      Chelyabinsk 454087 Russian Federation

      Ivanovo 153040 Russian Federation

      Kazan 420029 Russian Federation

      Krasnoyarsk 660022 Russian Federation

      Moscow 105425 Russian Federation

      Moscow 117997 Russian Federation

      Moscow 125284 Russian Federation

      Moscow 129301 Russian Federation

      Nizhny Novgorod 603001 Russian Federation

      Novosibirsk 630099 Russian Federation

      Obninsk 249036 Russian Federation

      Omsk 644013 Russian Federation

      Orenburg 460021 Russian Federation

      Pyatigorsk 357502 Russian Federation

      Rostov-on-Don 344022 Russian Federation

      Saratov 410012 Russian Federation

      St. Petersburg 191104 Russian Federation

      St. Petersburg 194017 Russian Federation

      St. Petersburg 194354 Russian Federation

      St. Petersburg 197022 Russian Federation

      St. Petersburg 197758 Russian Federation

      St. Petersburg 197758 Russian Federation

      Tyumen 625041 Russian Federation

      Ufa 450008 Russian Federation

      Volgograd 400138 Russian Federation

      Belgrade 11000 Serbia

      Belgrade 11000 Serbia

      Belgrade 11080 Serbia

      Kragujevac 34000 Serbia

      Nis 18000 Serbia

      Bratislava 833 05 Slovakia

      Bratislava 85101 Slovakia

      Martin 036 59 Slovakia

      Presov 080 81 Slovakia

      Skalica 90982 Slovakia

      Trencin 91101 Slovakia

      George Eastern Cape 3530 South Africa

      George Eastern Cape 6530 South Africa

      Port Elizabeth Eastern Cape 6045 South Africa

      Johannesburg Gauteng 2193 South Africa

      Pretoria Gauteng 0083 South Africa

      Durban Kwazulu-Natal 4126 South Africa

      Paarl Western Cape 7646 South Africa

      Rondebosch Western Cape 7700 South Africa

      Somerset West Western Cape 7130 South Africa

      Cape Town 7505 South Africa

      Cape Town 7925 South Africa

      Elche Alicante 03203 Spain

      Cádiz Andalucía 11009 Spain

      L'Hospitalet de Llobregat Barcelona 08907 Spain

      Sabadell Barcelona 08208 Spain

      Terrassa Barcelona 08221 Spain
      Jerez de la Frontera Cádiz 11407 Spain
      Manacor Illes Baleares 07500 Spain
      Palma de Mallorca Illes Baleares 07010 Spain
      Alcorcón Madrid 28922 Spain
      Fuenlabrada Madrid 28942 Spain
      Barakaldo Vizcaya 48903 Spain

      Barcelona 08025 Spain

      Barcelona 08035 Spain

      Barcelona 08036 Spain

      Bilbao 48013 Spain

      Córdoba 14004 Spain

      Granada 18012 Spain

      Granada 18014 Spain

      Lugo 27003 Spain

      Madrid 28007 Spain

      Madrid 28040 Spain

      Madrid 28041 Spain

      Madrid 28046 Spain

      Madrid 28050 Spain

      Málaga 29010 Spain

      Pamplona 31008 Spain

      Salamanca 37007 Spain

      Sevilla 41013 Spain

      Sevilla 41071 Spain

      Valencia 46009 Spain

      Valencia 46015 Spain

      Valencia 46026 Spain

      Valencia 46026 Spain

      Borås 501 82 Sweden

      Göteborg 413 45 Sweden

      Stockholm 171 76 Sweden

      Uppsala 751 85 Sweden

      Örebro 701 85 Sweden

      Kaohsiung City , Taiwan

      Kaoshiung 813 Taiwan

      Taichung 40705 Taiwan

      Taipei 10002 Taiwan

      Taoyuan 333 Taiwan

      Ankara 06560 Turkey

      Ankara 6100 Turkey

      Istanbul 34730 Turkey

      Izmir Turkey

      Manisa 45010 Turkey

      Sivas 58140 Turkey

      Chernivtsi 58002 Ukraine

      Dnipropetrovsk 49102 Ukraine

      Kharkiv 61037 Ukraine

      Kryvyi Rih 50048 Ukraine

      Kyiv 252053 Ukraine

      Kyiv 2660 Ukraine

      Uzhgorod 88014 Ukraine

      Zaporozhye 69600 Ukraine

      Reading Berkshire RG1 5AN United Kingdom

      Llanelli Carmarthenshire SA14 8QF United Kingdom

      Romford Essex RM7 0AG United Kingdom

      Stevenage Hertfordshire SG1 4AB United Kingdom

      Maidstone Kent ME16 9QQ United Kingdom

      Preston Lancashire PR2 4HT United Kingdom

      Bebington Merseyside CH63 4JY United Kingdom

      Scunthorpe North East Lincolnshire DN15 7BH United Kingdom

      Bath Somerset BA1 3NG United Kingdom

      Stoke-on-Trent Staffordshire ST4 6QG United Kingdom

      Dudley West Midlands DY1 2HQ United Kingdom

      Huddersfield West Yorkshire HD3 3EA United Kingdom

      Wakefield West Yorkshire WF1 4DG United Kingdom
      Worcester Worcestershire WR5 1DD United Kingdom
      Cardiff CF14 4XN United Kingdom>
      Dundee DD2 1UB United Kingdom
      Glasgow G12 0YN United Kingdom
      Kent DA2 8DA United Kingdom
      London SW17 0QT United Kingdom
      London SW3 6JJ United Kingdom
      Wrexham LL13 7TD United Kingdom

    View trial on ClinicalTrials.gov


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    Published March 7, 2017
  • A Pharmacodynamic Pre-surgical Study of Hedgehog Pathway Inhibition With LDE225 in Men With High-risk Localized Prostate Cancer.

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    A Pharmacodynamic Pre-surgical Study of Hedgehog Pathway Inhibition With LDE225 in Men With High-risk Localized Prostate Cancer.


    Condition: Prostate Cancer

    Intervention:

    • Drug: LDE225

    Purpose: This trial is designed as a randomized two-arm (LDE225 vs. observation groups) open-label prospective clinical trial in men with localized high-risk prostate cancer undergoing radical prostatectomy. The investigators propose to determine the effects of LDE225 on neoplastic prostate tissue from men at high risk of systemic disease progression, by comparing pre-surgical core-biopsy specimens to tumor tissue harvested at the time of prostatectomy.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02111187

    Sponsor: Sidney Kimmel Comprehensive Cancer Center

    Primary Outcome Measures:

    • Measure: Change from Baseline in Tissue Gli1 Expression levels using qRT-PCR analysis in each group (LDE225 and observation)
    • Time Frame: Up to 3 Years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Pathological effect of presurgical treatment with LDE225
    • Time Frame: Up to 3 years
    • Safety Issue:
    • Measure: Effect of LDE225 on PSA recurrence following prostatectomy
    • Time Frame: Up to 3 years
    • Safety Issue:
    • Measure: Number of Participants with Adverse Events in each group (LDE225 and observation)
    • Time Frame: Up to 3 years
    • Safety Issue:

    Estimated Enrollment: 14

    Study Start Date: April 2014

    Phase: Phase 1

    Eligibility:

    • Age: minimum 18 Years maximum 100 Years
    • Gender: Male

    Inclusion Criteria:

    • 1. Provide written informed consent prior to any screening procedures. 2. Age 18 years or older. 3. Histologically-documented prostatic adenocarcinoma in ≥2 cores 4. ECOG performance status ≤2 5. Localized prostate cancer with at least one of the following NCCN high-risk features:
    • Gleason sum ≥8
    • PSA >20 ng/mL
    • Clinical stage ≥T3 6. Must be a candidate for radical prostatectomy 7. No evidence of known metastatic disease (M0 or Mx allowed) 8. Adequate bone marrow, liver and renal function as specified below:
    • Absolute neutrophil count (ANC) ≥ 1500/µL
    • Hemoglobin (Hgb) ≥ 9.0 g/dL
    • Platelets ≥100,000/µL
    • Serum total bilirubin ≤ 1.5 x ULN (upper limit of normal)
    • AST and ALT ≤ 2.5 x ULN
    • Plasma creatine phosphokinase (CK) < 1.5 x ULN, if known
    • Serum creatinine ≤ 1.5 x ULN [or 24-hour creatinine clearance ≥ 50ml/min] 9. Patient is able to swallow and retain oral medications

    Exclusion Criteria:

    • 1. Patients who have had major surgery within 4 weeks of enrollment. 2. Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study. 3. Patients unable to take oral drugs (e.g. lack of physical integrity of the upper GI tract or known malabsorption syndromes). 4. Patients who have previously been treated with LDE225 or other Hh pathway inhibitors 5. Patients who have neuromuscular or muscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are known to cause rhabdomyolysis (such as statins and fibrates), and that cannot be discontinued at least 2 weeks prior to starting LDE225. If it is essential that the patient stays on a statin for hyperlipidemia, only pravastatin may be used with extra caution. Patients should not plan to embark on a new strenuous exercise regimen after initiation of study treatment. (NB: Muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided whilst on LDE225 treatment). 6. Patients who have taken part in an experimental drug study within 4 weeks or 5 half-lives (whichever is longer) of initiating treatment with LDE225. 7. Patients who are receiving other anti-neoplastic therapy (e.g. chemotherapy, targeted therapy or radiotherapy) concurrently or within 2 weeks of starting LDE225. 8. Patients taking moderate/strong inhibitors or inducers of CYP3A4/5 or drugs metabolized by CYP2B6 or CYP2C9 that have narrow therapeutic index, and that cannot be discontinued before starting treatment with LDE225. Medications that are strong CYP3A4/5 inhibitors should be discontinued for at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with LDE225. 9. No concurrent use of statins (except for pravastatin, if absolutely necessary) 10. No concurrent warfarin or Coumadin-derivatives 11. Impaired cardiac function or significant heart disease, including any one of the following:
    • Angina pectoris within 3 months
    • Acute myocardial infarction within 3 months
    • QTc >450 msec on the screening ECG
    • A past medical history of clinically significant ECG abnormalities or a family history of prolonged QT-interval syndrome
    • Other clinically significant heart disease (e.g. heart failure, uncontrolled/labile hypertension, or history of poor compliance with an antihypertensive regimen) 12. Patients who are not willing to apply highly effective contraception during the study and through the duration of LDE225 treatment.
    • Male patients must use highly effective (double barrier) methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, and continuing using contraception and refrain from fathering a child for 6 months following the last dose of the study drug. A condom is also required to be used by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the study treatment via seminal fluid. Sexually active males must be willing to use a condom during intercourse while taking the study drug and for 6 months after stopping investigational medications and agree not to father a child during this period. 13. Patients unwilling or unable to comply with the research protocol.

    Location:

    • Johns Hopkins Hospital
    • Baltimore Maryland 21205 United States

    View trial on ClinicalTrials.gov


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    Published January 10, 2017
  • A Phase 1 Dose Escalation Study of MGA271 in Refractory Cancer

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    A Phase 1 Dose Escalation Study of MGA271 in Refractory Cancer


    Condition: Prostate Cancer, Melanoma, Renal Cell Carcinoma, Triple-negative Breast Cancer, Head and Neck Cancer, Bladder Cancer, Non-small Cell Lung Cancer

    Intervention:

    • Biological: MGA271

    Purpose: The purpose of this study is to evaluate the safety of MGA271 when given by intravenous (IV) infusion to patients with refractory cancer. The study will also evaluate how long MGA271 stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be given, and whether it may have an effect on tumors.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01391143

    Sponsor: MacroGenics

    Primary Outcome Measures:

    • Measure: Safety
    • Time Frame: Study Day 50 or 28 days after last infusion
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Maximum tolerated dose
    • Time Frame: Study Day 50 or 28 days after last infusion
    • Safety Issue:

    Estimated Enrollment: 151

    Study Start Date: July 2011

    Phase: Phase 1

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • Histologically or cytologically confirmed carcinoma (prostate cancer, renal cell carcinoma, head and neck cancer, triple-negative breast cancer, bladder cancer, non-small cell lung cancer) or melanoma that overexpresses B7-H3.
    • Progressive disease during or after last treatment regimen.
    • Appropriate treatment history for histological entity.
    • ECOG Performance Status <= 1.
    • Life expectancy >= 3 months.
    • Measurable disease or evaluable disease with relevant tumor marker elevation.
    • Acceptable laboratory parameters and adequate organ reserve.

    Exclusion Criteria:

    • Major surgery or trauma within four weeks before enrollment.
    • Known hypersensitivity to murine or recombinant proteins, polysorbate 80, or any excipient contained in the drug formulation.
    • Grade 3 colitis, hepatitis, pneumonitis uveitis, myocarditis, myositis, CNS toxicity or autoimmune related neuromuscular toxicity such as myasthenia gravis associated with the administration of an immune checkpoint inhibitor
    • Second primary malignancy that has not been in remission for greater than 3 years. Treated non-melanoma skin cancer, cervical carcinoma in situ on biopsy, or squamous intraepithelial lesion on PAP smear, localized prostate cancer (Gleason score < 6), or resected melanoma in situ are exceptions and do not require a 3 year remission.
    • Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within four weeks of enrollment. Patients requiring any oral antiviral, fungal, or bacterial therapy must have completed treatment within one week of enrollment.
    • Vaccination within 2 weeks of enrollment (except for annual flu vaccine).
    • History of chronic or recurrent infections that require continual use of antiviral, antifungal, or antibacterial agents.

    Contact:

    • Bing Nie
    • 240-552-8084

    Locations:

    • UCLA Hematology-Oncology Clinic
    • Los Angeles California 90095 United States
    • Yale Cancer Center
    • New Haven Connecticut 06520 United States
    • Moffitt Cancer Center
    • Tampa Florida 33612 United States
    • The University of Chicago
    • Chicago Illinois 60637 United States
    • Norton Cancer Institute
    • Louisville Kentucky 40202 United States
    • University of Maryland
    • Baltimore Maryland 21201 United States
    • Neely Center for Clinical Cancer Research, Tufts Medical Center
    • Boston Massachusetts 02111 United States
    • Massachusetts General Hospital Cancer Center
    • Boston Massachusetts 02114 United States
    • Dana Farber Cancer Institute
    • Boston Massachusetts 02215 United States
    • Carolina Biooncology Institute
    • Huntersville North Carolina 28078 United States
    • Hospital of the University of Pennsylvania/Abramson Cancer Center
    • Philadelphia Pennsylvania 19104 United States
    • Sarah Cannon Research Institute
    • Nashville Tennessee 37203 United States

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • A Phase 1 Study of Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer

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    A Phase 1 Study of Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer


    Condition: Prostate Cancer

    Intervention:

    • Biological: Allogeneic Human Mesenchymal Stem Cells

    Purpose: The objective of this study is to determine if systemically infused allogeneic bone marrow derived mesenchymal stem cells (MSC) home to sites of prostate cancer in men with localized adenocarcinoma of the prostate that are planning to undergo a prostatectomy. Investigators plan to systemically infuse MSCs 4, 6 or 8 days prior to enrolled subjects' planned prostatectomies. Investigators will then quantify the relative amount of donor MSC DNA to recipient DNA present in patients' explanted prostate specimens. This will be accomplished via BEAMing digital PCR. This trial will provide the foundation for future studies aimed at engineering MSCs to deliver a toxin to sites of metastatic prostate cancer.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01983709

    Sponsor: Sidney Kimmel Comprehensive Cancer Center

    Primary Outcome Measures:

    • Measure: To quantify the amount of systemically infused (MSC) DNA relative to recipient DNA at sites of prostate cancer in men with localized adenocarcinoma of the prostate that are scheduled to undergo a prostatectomy
    • Time Frame: Up to 3 years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Feasibility of infusing MSCs into men with localized prostate cancer who plan to undergo a prostatectomy.
    • Time Frame: Up to 3 years
    • Safety Issue:
    • Measure: Determine the proportion of MSC to recipient DNA in the peripheral blood at serial time points.
    • Time Frame: Up to 3 years
    • Safety Issue:
    • Measure: Determine the proportion of MSC to recipient DNA within the seminal vesicle.
    • Time Frame: Up to 3 years
    • Safety Issue:
    • Measure: Changes in the Sexual Health Inventory for Men (SHIM) and Expanded Prostate Cancer Index Composite (EPIC) surveys post-prostatectomy.
    • Time Frame: Up to 3 years
    • Safety Issue:
    • Measure: Safety
    • Time Frame: Up to 3 years
    • Safety Issue:

    Estimated Enrollment: 7

    Study Start Date: October 2013

    Phase: Phase 1

    Eligibility:

    • Age: minimum 18 Years maximum 100 Years
    • Gender: Male

    Inclusion Criteria:

    1. (MSC donor cohort):
    2. Age ≥18 years, ≤30 years
    3. Male sex
    4. Donor must meet the selection and

    Eligibility Criteria:

    1. as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FACT) and FDA 21 CFR Part 1271 Exclusion Criteria:(MSC donor cohort):
    2. Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.
    3. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
    4. Inability to provide informed consent. MSC Recipients Inclusion Criteria (Treatment cohort):
    5. Age ≥18 years
    6. Eastern cooperative group (ECOG) performance status ≤2
    7. Documented histologically confirmed adenocarcinoma of the prostate
    8. Gleason score on diagnostic biopsy specimens of ≥ 6
    9. ≥ 3 positive cores within diagnostic biopsy specimens
    10. At least one prostate core must contain ≥ 30% prostate cancer
    11. Scheduled to undergo a prostatectomy at Johns Hopkins
    12. Has not received systemic therapy for prostate cancer (i.e. LHRH agonist/antagonist therapy)
    13. Sexual Health Inventory in Men (SHIM) score ≥ 17

    Exclusion Criteria:

    1. (MSC donor cohort):
    2. Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.
    3. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
    4. Inability to provide informed consent. MSC Recipients Inclusion Criteria (Treatment cohort):
    5. Age ≥18 years
    6. Eastern cooperative group (ECOG) performance status ≤2
    7. Documented histologically confirmed adenocarcinoma of the prostate
    8. Gleason score on diagnostic biopsy specimens of ≥ 6
    9. ≥ 3 positive cores within diagnostic biopsy specimens
    10. At least one prostate core must contain ≥ 30% prostate cancer
    11. Scheduled to undergo a prostatectomy at Johns Hopkins
    12. Has not received systemic therapy for prostate cancer (i.e. LHRH agonist/antagonist therapy)
    13. Sexual Health Inventory in Men (SHIM) score ≥ 17 Exclusion Criteria (Treatment cohort):
    14. Prior radiation therapy to the prostate.
    15. Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.
    16. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
    17. Inability to provide informed consent.
    18. Any active autoimmune disease requiring treatment (e.g. steroid, disease-modifying antirheumatic drugs, biologic agents, etc.).
    19. Prior history of penicillin or streptomycin allergy.
    20. No prior history of deep venous thrombosis or pulmonary embolism within 5 years prior to enrollment in the study.
    21. Abnormal liver function (bilirubin, AST, ALT ≥ 3 x upper limit of normal)
    22. Abnormal kidney function (serum creatinine ≥ 2 x upper limit of normal)
    23. Abnormal cardiac function as manifested by NYHA (New York Heart Association) class III or IV heart failure or history of a prior myocardial infarction (MI) within the last five years prior to enrollment in the study.
    24. History of symptomatic pulmonary dysfunction.

    Location:

    • Johns Hopkins Hospital
    • Baltimore Maryland 21205 United States

    View trial on ClinicalTrials.gov


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    Published January 10, 2017
  • A Phase 1 Trial for Evaluation of the Safety, Pharmacokinetics, and [18F] Radiation Dosimetry of CTT1057, a Small Molecule Inhibitor of Prostate Specific Membrane Antigen (PSMA)

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    A Phase 1 Trial for Evaluation of the Safety, Pharmacokinetics, and [18F] Radiation Dosimetry of CTT1057, a Small Molecule Inhibitor of Prostate Specific Membrane Antigen (PSMA)


    Condition: Prostate Cancer

    Intervention:

    • Drug: CTT1057
    • Procedure: Prostatectomy

    Purpose: The purpose of this study is to test a novel diagnostic Positron Emission Tomography (PET) imaging agent for safety and biodistribution. The agent binds Prostate Specific Membrane Antigen (PSMA) and is designed to detect prostate tumors.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02916537

    Sponsor: Cancer Targeted Technology

    Primary Outcome Measures:

    • Measure: Adverse event frequency as graded by Common Toxicity Criteria version 4.03
    • Time Frame: 7 days from time of injection
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Organ dosimetry/tissue uptake of CTT1057 as measured by PET/MR imaging of prostate cancer
    • Time Frame: Up to six hours from time of injection
    • Safety Issue:
    • Measure: Pharmacokinetic profile of CTT1057 as measured by radiotracer detection in blood samples
    • Time Frame: Up to four hours from time of injection
    • Safety Issue:
    • Measure: Level of CTT1057 uptake on PET/MR imaging of localized prostate cancer with PSMA protein expression by immunohistochemistry from subsequent radical prostatectomy specimens
    • Time Frame: 12 weeks
    • Safety Issue:
    • Measure: Optimal Standardized Uptake Value (SUV) ratio threshold on CTT1057 PET/MR for discriminating tumor pathology from primary prostate cancer tissue
    • Time Frame: 4 hours
    • Safety Issue:
    • Measure: Sensitivity and specificity of CTT1057 PET imaging on a lesion-by-lesion basis as compared with standard imaging in metastatic prostate cancer
    • Time Frame: 4 hours
    • Safety Issue:
    • Measure: Number of positive lesions on CTT1057 PET/MR in subjects with equivocal or negative conventional imaging scans
    • Time Frame: 4 hours
    • Safety Issue:
    • Measure: Location of positive lesions on CTT1057 PET/MR in subjects with equivocal or negative conventional imaging scans
    • Time Frame: 4 hours
    • Safety Issue:

    Estimated Enrollment: 20

    Study Start Date: September 2016

    Phase: Phase 1

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Male patients age ≥18 years old
    • Histologically confirmed adenocarcinoma of the prostate
    • Adequate organ function including:
    • Platelet count of > 50,000/mm3
    • Neutrophil count of > 1000/mm3
    • Serum Cr < 1.5 x ULN or estimated GFR > 60 ml/min based upon Cockroft-Gault equation
    • Proteinuria < 1 g/24 hours based upon 24 hour urine collection or spot urine protein/creatinine ratio
    • AST and ALT < 2.5 x ULN (< 5 x ULN in patients with known liver metastases)
    • Total bilirubin < 1.5 x ULN (< 3 x ULN in patients with known/suspected Gilbert's disease)
    • ECOG performance status of 0 or 1
    • Able to provide written informed consent and willing to comply with protocol requirements
    • No contra-indication to MR including severe claustrophobia, incompatible aneurysm clips or cardiac pacemaker
    • For men of childbearing potential, the use of effective contraceptive methods during the trial and within 6 months following radiotracer injection
    • Cohort A only (N = 5 evaluable patients):- Planned radical prostatectomy within 12 weeks following protocol scan
    • No androgen deprivation, anti-androgen therapy, chemotherapy, or investigational systemic therapy prior to CTT1057 PET imaging
    • Cohort B only:- Presence of at least three distinct metastatic lesions by standard imaging including whole body bone scan + cross-sectional imaging of the abdomen and pelvis obtained within 12 weeks prior to protocol scan
    • Castration-resistant disease as defined by PCWG2 criteria
    • Must remain on androgen deprivation therapy for duration of trial if no prior bilateral orchiectomy

    Exclusion Criteria:

    • Inadequate venous access per assessment of treating health care provider
    • Receipt of radioisotope within 5 physical half lives prior to trial enrollment
    • Prior treatment with alpha radiation therapy (Radium Ra 223 chloride; Xofigo™) during the previous 60 days
    • Have a medical condition or other circumstances that, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the trial.
    • Histologic evidence of small cell prostate cancer or neuroendocrine differentiation in > 50% of biopsy tissue

    Contact:

    • Kenneth Gao
    • 415 353-9437

    Location:

    • University of California San Francisco
    • San Francisco California 94143 United States

    View trial on ClinicalTrials.gov


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    Published January 12, 2017
  • A Phase 1 Window of Opportunity Study Investigating the Pharmacodynamic Biomarker Effects of AZD2014 (an mTOR1/2 Inhibitor) Given Prior to Radical Prostatectomy

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    A Phase 1 Window of Opportunity Study Investigating the Pharmacodynamic Biomarker Effects of AZD2014 (an mTOR1/2 Inhibitor) Given Prior to Radical Prostatectomy


    Condition: Prostate Cancer

    Intervention:

    • Drug: AZD2014

    Purpose: Patients with localised prostate cancer can be treated by radical prostatectomy (prostate gland removal surgery) or radiotherapy. Around 15% of men with prostate cancer are diagnosed with high risk disease meaning they are more likely to suffer treatment failure, disease progression and mortality. To date little progress has been made towards identifying effective treatment strategies that might delay or prevent disease recurrence in this patient population. Better identification of patients at high risk of relapse and improvements in therapy are therefore research priorities. A protein named Mammalian Target of Rapamycin (mTOR) is known to play an important role in the development of prostate cancer. mTOR forms two protein complexes (mTORC1 and mTORC2) and sends signals helping cancer cells to grow while controlling their energy use. Blocking the function of mTOR, with an inhibitor such as AZD2014, might shut down the supply of energy supply to tumour cells leading to reduced cell growth and potentially slowing the progression of the disease. The purpose of this study is to investigate the molecular pharmacology of AZD2014 treatment given to patients with prostate cancer prior to radical prostatectomy. The feasibility, safety and tolerability of a short course of AZD2014 will also be assessed.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02064608

    Sponsor: Cambridge University Hospitals NHS Foundation Trust

    Primary Outcome Measures:

    • Measure: To measure the amount of inhibition (percentage change from baseline) in mTORC1 and mTORC2 signalling in tumour samples from men with early, high-risk prostate cancer after AZD2014 treatment
    • Time Frame: 2 weeks
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: To determine the incidence of adverse events due to AZD2014 given prior to radical prostatectomy
    • Time Frame: 8 weeks unless further observation is clinically indicated
    • Safety Issue:
    • Measure: To determine the severity of adverse events due to AZD2014 prior to radical prostatectomy
    • Time Frame: 8 weeks unless further observation is clinically indicated
    • Safety Issue:

    Estimated Enrollment: 23

    Study Start Date: October 2014

    Phase: Phase 1

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Men aged 18 years old or older
    • ECOG performance status of 0 or 1
    • Clinical diagnosis of Intermediate (one or more of stage T2, or PSA >10ng/mL, or Gleason score of at least 7) or High Risk Prostate Cancer (one or more of stage T2c, or PSA >20ng/mL, or Gleason score of at least 8)
    • Patient suitable for radical prostatectomy, following discussion at specialist MDT and subsequent review by surgical team
    • Willing to use barrier contraceptive method, e.g. condom & spermicide
    • Adequate bone marrow reserve or organ function (as specified in the study protocol)
    • Normal chest radiograph and oxygen saturations, OR normal CT thorax

    Exclusion Criteria:

    • Contraindication to AZD2014 (as specified in the study protocol)
    • Patients who have experienced any of the following procedures in the past 12 months: coronary artery bypass graft; angioplasty; vascular stent; myocardial infarction; angina pectoris; congestive heart failure (New York Heart Association grade of 2 or above); ventricular arrhythmias requiring continuous therapy; supraventricular arrhythmias including atrial fibrillation, which are uncontrolled; haemorrhagic or thrombotic stroke including transient ischaemic attacks or any other CNS bleeding.
    • Previous chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents and/or investigational agents within 28 days of starting study treatment.
    • Major surgery within 4 weeks prior to study entry (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study
    • Potent or moderate inhibitors and inducers of CYP2C8 if taken within the stated wash-out period: Gemfibrozil, trimethoprim, glitazones, montelukast, deferasirox and quercetin (1-week minimum wash out period)
    • Any haematopoietic growth factors, e.g. G-CSF, GM-CSF, within 4 weeks prior to receiving study drug
    • As judged by the Investigator, any evidence of severe or uncontrolled systemic disease (as specified in the study protocol)
    • Abnormal ECHO or MUGA at baseline
    • Mean resting QTc of 470msec or above (as per local reading)
    • Concomitant medications known to prolong QT interval, or with factors that increase the risk of QTc prolongation, or risk of arrythmic events (examples specified in study protocol). History of Torsades de Pointes.
    • Patients with Diabetes Type I or uncontrolled Type II as judged by the investigator
    • Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.
    • Unable to provide informed consent

    Location:

    • Cambridge University Hospitals NHS Foundation Trust
    • Cambridge Cambridgeshire CB2 0QQ United Kingdom

    View trial on ClinicalTrials.gov


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    Published January 12, 2017
  • A Phase 2 Clinical Trial Exploring 3-Dimensional Imaging of Androgen Deprivation Induced Osteoporosis, Radiotherapy Hypofractionation and the Prognostic Significance of Micrometastatic Disease in Men With Prostate Cancer

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    A Phase 2 Clinical Trial Exploring 3-Dimensional Imaging of Androgen Deprivation Induced Osteoporosis, Radiotherapy Hypofractionation and the Prognostic Significance of Micrometastatic Disease in Men With Prostate Cancer


    Condition: Prostate Cancer

    Purpose: This is a single centre prospective observational noninterventional study of men with histological confirmed prostate cancer, high risk disease and not positive for metastatic disease planned to receive Radiotherapy and 18 months of Androgen Deprivation Therapy (ADT). Although ADT improves the chance of cure, it can also have many side effects. One of these is bone mineral density loss. When this is advanced, it is called osteoporosis. Men with osteoporosis have a higher chance of getting fractures of bones such as the hip and spine. Currently, the best way to measure for osteoporosis is to do a bone mineral density scan using a DEXA scanner. The primary objective of this study is to see if baseline Magnetic Resonance Imager (MRI) and a Computer Tomogram (CT) combined with clinical factors predicts which men are at greater risk of accelerated ADT induced bone mineral density loss than baseline DEXA scanning alone. The data from the patients will be used to construct a model predicting annual rate of bone loss based on baseline imaging, clinical and biochemical characteristics. Secondary aims for this study are as follows: - Evaluating the feasibility, toxicity (acute and late) and efficacy (5 year biochemical control by the Phoenix definition)of multimodality therapy with hypofractionated radiotherapy (giving a larger dose of radiotherapy over a shorter time 5½ weeks compared with a standard 8 week approach). Although used overseas, this 5½ week regimen has not been used widely in Australia, and we would like to see if we gain similar results here as have been reported from the US. - Feasibility and efficacy of a risk adapted duration of neoadjuvant hormonal therapy. Usually, ADT is given for between 19 months before radiotherapy is started but there is no agreement as to which duration is best. This trial aims to tailor the duration of ADT prior to radiotherapy based on blood PSA test results. - Prognostic value of circulating tumour cells (CTCs). This is a blood test which can detect cancer cells in the blood which has been used for patients with metastatic cancer. The presence of CTCs in men with prostate cancer correlated with poorer overall survival. Potentially, high risk prostate cancer patients with CTCs detected may represent a very high risk group and could therefore warrant treatment intensification. - To correlate bone marrow changes on MRI with changes in blood counts and patient reported fatigue. Measuring bone marrow may help in predicting not just which patients are at risk of losing bone faster but also of becoming anaemic, and suffering fatigue. A correlation may better explain some of the toxicities associated with ADT. - Implementation of a nomogram based radiotherapy target delineation algorithm. This trial aims to use a decision making tool called a nomogram to help tailor the area to treat in a more standard way.

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT01418040

    Sponsor: Calvary Mater Newcastle, Australia

    Primary Outcome Measures:

    • Measure: Prediction of ADT induced bone mineral density loss
    • Time Frame: 6 years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Feasibility, toxicity and efficacy of multimodality therapy with hypofractionated radiotherapy
    • Time Frame: 5 years
    • Safety Issue:
    • Measure: To correlate marrow changes on MR with changes in blood counts and patient reported fatigue
    • Time Frame: 6 years
    • Safety Issue:
    • Measure: Prognostic value of circulating tumour cells
    • Time Frame: 6 years
    • Safety Issue:
    • Measure: Implementation of a risk adapted duration of neoadjuvant hormonal therapy
    • Time Frame: 6 years
    • Safety Issue:
    • Measure: Implementation of a nomogram based radiotherapy target delineation algorithm
    • Time Frame: 6 years
    • Safety Issue:

    Estimated Enrollment: 28

    Study Start Date: July 2011

    Eligibility:

    • Age: minimum N/A maximum N/A
    • Gender: Male

    Inclusion Criteria:

    1. Patient capable of giving informed consent
    2. Histological diagnosis of prostate cancer
    3. High risk disease defined by any one of:
    4. Baseline PSA>20
    5. Gleason grade 8 disease
    6. Clinical stage T3-T4
    7. Negative conventional staging in the form of a:
    8. T99m whole body bone scan
    9. CT of the abdomen and pelvis
    10. No previous pelvic radiotherapy

    Exclusion Criteria:

    1. History of prior malignancy within the last 5 years with the exception of non-melanomatous skin cancers.
    2. ECOG performance status >1
    3. Inability to have intraprostatic fiducials inserted.
    4. Inability to be given an MRI due to:
    5. Implanted magnetic metal eg intraocular metal
    6. Pacemaker / Implantable defibrillator
    7. Extreme claustrophobia

    Location:

    • Calvary Mater Newcastle
    • Waratah New South Wales 2305 Australia

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • A Phase 2 Trial of Nivolumab Plus Ipilimumab in Men With Metastatic Castration-Resistant Prostate Cancer

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    A Phase 2 Trial of Nivolumab Plus Ipilimumab in Men With Metastatic Castration-Resistant Prostate Cancer


    Condition: Prostate Cancer

    Intervention:

    • Biological: Nivolumab
    • Biological: Ipilimumab

    Purpose: The purpose of this study is to determine whether nivolumab plus ipilimumab has preliminary evidence of safety and effectiveness in treatment of metastatic castration-resistant prostate cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02985957

    Sponsor: Bristol-Myers Squibb

    Primary Outcome Measures:

    • Measure: Objective Response Rate (ORR)
    • Time Frame: Approximately 24 weeks from treatment initiation
    • Safety Issue:
    • Measure: Radiographic Progression-Free Survival (rPFS)
    • Time Frame: Approximately 12 months from treatment initiation
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Radiographic/Clinical Progression-Free Survival (rcPFS)
    • Time Frame: Approximately 12 months from treatment initiation
    • Safety Issue:
    • Measure: Overall Survival (OS)
    • Time Frame: Up to 5 years from treatment initiation
    • Safety Issue:
    • Measure: Number of patients with adverse events
    • Time Frame: Approximately 12 months from treatment initiation
    • Safety Issue:
    • Measure: Number of patients with serious adverse events
    • Time Frame: Approximately 12 months from treatment initiation
    • Safety Issue:
    • Measure: Number of patients with adverse events leading to discontinuation
    • Time Frame: Approximately 12 months from treatment initiation
    • Safety Issue:
    • Measure: Number of patients with immune-mediated adverse events
    • Time Frame: Approximately 12 months from treatment initiation
    • Safety Issue:
    • Measure: Number of patients with deaths
    • Time Frame: Approximately 12 months from treatment initiation
    • Safety Issue:
    • Measure: Number of patients with laboratory abnormalities
    • Time Frame: Approximately 12 months from treatment initiation
    • Safety Issue:
    • Measure: Number of patients with changes in pain as measured by Brief Pain Inventory-Short Form (BPI-SF)
    • Time Frame: Approximately 12 months from treatment initiation
    • Safety Issue:
    • Measure: European Quality of Life- Five Dimensions (EQ-5D-3L) scores
    • Time Frame: Approximately 12 months from treatment initiation
    • Safety Issue:

    Estimated Enrollment: 90

    Study Start Date: March 17, 2017

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Metastatic, castrate resistant prostate cancer (M1 by National Comprehensive Cancer Network (NCCN) criteria)
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    • Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone (GnRH) analogue or a surgical/medical castration with testosterone level of ≤1.73nmol/L (50ng/dL)
    • Patients with skeletal system symptoms who are already on medications to strengthen bones are allowed if they were started ˃28 days before study treatment
    • Bone-directed radiotherapy to pelvic region for ease of pain from painful bone metastases is allowed up to 14 days before Exclusion Criteria:
    • Cancer that has spread to the liver or brain
    • Active, known, or suspected autoimmune disease or infection
    • Prior treatment with any drug that targets T cell co-stimulation pathways(such as checkpoint inhibitors) Other protocol defined inclusion/

    Exclusion Criteria:

    • Cancer that has spread to the liver or brain
    • Active, known, or suspected autoimmune disease or infection
    • Prior treatment with any drug that targets T cell co-stimulation pathways(such as checkpoint inhibitors) Other protocol defined inclusion/exclusion criteria could apply

    Contact:

    • Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
    • please email:

    Locations:

    • University of Chicago
    • Chicago Illinois 60637 United States
    • Washington University School Of Medicine
    • Saint Louis Missouri 63110 United States
    • Icahn School Of Medicine At Mount Sinai
    • New York New York 10029 United States
    • Local Institution
    • New York New York 10065 United States
    • University Of Pennsylvania
    • Philadelphia Pennsylvania 19104 United States
    • MD Anderson Cancer Center
    • Houston Texas 77030 United States
    • Local Institution
    • Clermont-ferrand 63000 France
    • Local Institution
    • Lyon 69008 France
    • Local Institution
    • Marseille Cedex 9 13273 France
    • Local Institution
    • Villejuif 94805 France

    View trial on ClinicalTrials.gov


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    Published August 1, 2017
  • A Phase I-II Dose Escalation Study of Stereotactic Body Radiation Therapy in Patients With Localized Prostate Cancer

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    A Phase I-II Dose Escalation Study of Stereotactic Body Radiation Therapy in Patients With Localized Prostate Cancer


    Condition: Prostate Adenocarcinoma

    Intervention:

    • Radiation: Stereotactic Body Radiation Therapy (SBRT)

    Purpose: The aim of this study is to test the safety and efficacy of Stereotactic Body Radiation Therapy (SBRT) in localized prostate carcinoma in patients for whom the standard treatment is the irradiation of the entire prostate gland with or without seminal vesicles accompanied or not by hormonal therapy. In light of the accumulating clinical evidence favoring the use of hypo fractionation, SBRT regimen might constitute a much more convenient non-invasive and highly efficient outpatient therapy.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02254746

    Sponsor: Centre Hospitalier Universitaire Vaudois

    Primary Outcome Measures:

    • Measure: Maximum tolerated dose (phase I)
    • Time Frame: During the first 30 days from the start of treatment
    • Safety Issue:
    • Measure: Toxicity (phase II)
    • Time Frame: 90 days after the first fraction of radiotherapy treatment
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Efficacy (phase II)
    • Time Frame: 3 monthly assessments during the first 2 years and 6 monthly assessments until end of study (5 years)
    • Safety Issue:
    • Measure: Toxicity (phase II)
    • Time Frame: > 90 days and up to 5 years from the start of protocol treatment
    • Safety Issue:

    Estimated Enrollment: 27

    Study Start Date: September 2014

    Eligibility:

    • Age: minimum 18 Years maximum 99 Years
    • Gender: All

    Inclusion Criteria:

    • All patients must be willing and capable to provide informed consent
    • Histologic confirmation of prostate adenocarcinoma
    • T2-T3 tumors, N0 (clinically by no evidence of metastatic lymph nodes on CT or MRI)
    • No direct evidence of regional or distant metastases
    • PSA less than or equal to 50 μg/ml
    • Visible gross tumor at the prostate endorectal coil MRI.
    • The ultrasound or MRI based volume estimation of the patient's prostate gland no greater than 70g or 70cc
    • No significant urinary obstructive symptoms; IPSS score must be ≤ 15 (alpha blockers allowed)
    • Patient must have undergone an endorectal coil magnetic resonance image (MRI) of the prostatic gland (before rectal spacer if any),
    • Patient must have undergone the following assessments in case of PSA ≥ 20μg/L, and/or T3 tumor and/or Gleason Score ≥ 8:
    • bone scan
    • Chest abdominal and pelvis computed tomography (CT) scan
    • If tumor is localized at less than 3 mm from the rectum a rectal spacer is mandatory. Patient accepts the rectal spacer to be injected before treatment starts
    • Patient accepts to have one planning MRI after the injection of rectal spacer (without endorectal coil)
    • Patient accepts the preparation of the bladder (bladder full), before the planning MRI, planning CT and then before each treatment fraction

    Exclusion Criteria:

    • Previous radiotherapy in the pelvis
    • Tumor localized at less than 3 mm from the urethra
    • History of inflammatory colitis (including Crohn's disease and ulcerative colitis)
    • Prior cancer in the pelvis
    • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before inclusion in the trial

    Contact:

    • Fernanda Herrera, MD
    • 21 314 46 00 Ext. +41

    Location:

    • Centre Hospitalier Universitaire Vaudois
    • Lausanne 1011 Switzerland

    View trial on ClinicalTrials.gov


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    Published January 10, 2017
  • A Phase Ib/IIa Study of Rucaparib (PARP Inhibitor) Combined With Nivolumab in Metastatic Castrate - Resistant Prostate Cancer and Advanced/Recurrent Endometrial Cancer

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    A Phase Ib/IIa Study of Rucaparib (PARP Inhibitor) Combined With Nivolumab in Metastatic Castrate - Resistant Prostate Cancer and Advanced/Recurrent Endometrial Cancer


    Condition: Prostate Cancer, Endometrial Cancer

    Intervention:

    • Drug: Rucaparib
    • Drug: Nivolumab

    Purpose: This is a phase 1/phase 2a study of the combination of immune checkpoint inhibitor (nivolumab) in combination with the PARP inhibitor (rucaparib) for patients with metastatic castration resistant prostate cancer (mCRPC) and metastatic/recurrent endometrial cancer. In the phase 1 portion, the safety of the combination dosing will be determined. If the combination dosing is determined to be safe and feasible, the study will move onto phase 2a. In the phase 2a portion, participants will be randomized to receive either: rucaparib alone, nivolumab alone, or combination therapy (rucaparib and nivolumab).

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03572478

    Sponsor: University of Chicago

    Primary Outcome Measures:

    • Measure: Dose limiting toxicities (DLT) rate of the combination of rucaparib and nivolumab
    • Time Frame: 8 weeks
    • Safety Issue:

    Estimated Enrollment: 60

    Study Start Date: August 14, 2018

    Phase: Phase 1/Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • Patients must have the ability to understand and the willingness to signed a written informed consent document.
    • Patients must have histologically or cytologically confirmed CRPC or endometrial cancer that is metastatic. Evidence of disease progression on a prior therapy is not required.
    • Patients must have at least one lesion that is amenable to biopsy and the treating physician must deem this safe.
    • Patient must be willing to undergo two mandatory research-only biopsies.
    • Prostate cancer patients:
    • Patients must be surgically or medically castrated, with serum testosterone levels ≤ 50 ng/mL Patients being treated with Gonadotropin-releasing hormone (GnRH) agonists must have such therapy continued throughout the study.
    • Patients should have received at least one androgen receptor (AR)-targeted therapy with abiraterone acetate or enzalutamide. Multiple lines of prior AR-targeted therapy and chemotherapy are permitted. A washout of two weeks from prior endocrine therapy (other than GnRH agonist); four weeks washout period from prior cytotoxic chemotherapy or other anticancer agents is required (prior to day 1 of study therapy); six weeks washout period to allow for anti-androgen withdrawal for patients managed with antiandrogen therapy such as bicalutamide.
    • Endometrial cancer patients:
    • An unlimited number of prior hormonal and/or chemotherapy regimens are permitted. A washout of two weeks from prior endocrine therapy (other than GnRH agonist) and four weeks from prior cytotoxic chemotherapy or other anticancer agents is required (prior to day 1 of study therapy).
    • At least 5 days should have elapsed since any non-study related minor surgical procedure and at least 21 days since any major surgical procedure prior to the first dose of rucaparib and the first dose of nivolumab.
    • Must have an ability to swallow pills or capsules. Patients should have no current clinical evidence of bowel obstruction.
    • Age must be ≥ 18 years.
    • Eastern Cooperative Oncology Group (ECOG) performance status must be ≤ 1
    • Patients must have normal hepatic, renal and marrow function as defined below:
    • hemoglobin > 10 g/dL
    • leukocytes ≥ 3,000/mcL
    • absolute neutrophil count ≥ 1,500/mcL
    • platelets ≥ 150,000/mcL
    • total bilirubin within normal institutional limits
    • alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × institutional upper limit of normal
    • creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
    • Prior palliative radiotherapy must have been completed at least 2 weeks prior to first dose of study drug. Subjects with symptomatic tumor lesions at baseline that may require palliative radiotherapy within 4 weeks of first dose of study drug are strongly encouraged to receive palliative radiotherapy prior to enrollment.
    • Reproductive Status: Rucaparib caused post-implantation loss (100% early resorptions) at all doses administered in an embryo-fetal development study. Based on its mechanism of action, nivolumab can cause fetal harm when administered to a pregnant woman. Pregnant women are therefore not eligible for this study.
    • Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test result less than 3 days prior to administration of the first dose of rucaparib.
    • WOCBP must not be considering getting pregnant during the study.
    • WOCBP and their male partners must agree to use a highly effective, reliable form of contraception during treatment; for 6 months following the last dose of rucaparib; and for at least 5 months following the last dose of nivolumab.
    • Men who are sexually active with WOCBP must agree to use a highly effective, reliable form of contraception during treatment; 6 months following the last dose of rucaparib; and for a period of 7 months after the last dose of nivolumab .
    • In addition to the above methods of contraception, use of a condom by male patients is recommended to prevent transfer of drug through semen.

    Exclusion Criteria:

    • Patients with active, known, or suspected autoimmune disease. Subjects with vitiligo, type I diabetes, mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, childhood asthma that is not currently active, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
    • Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration except for adrenal replacement steroid doses > 10 mg daily prednisone equivalent in the absence of active autoimmune disease. Note: Treatment with a short course of steroids (< 5 days) up to 7 days prior to initiating study drug is permitted.
    • Patients who are receiving any other investigational agents.
    • Prior exposure to PD-1 or PD-L1 inhibitors, other immune checkpoint inhibitors (e.g. anti-LAG-3, and anti-CTLA-4 antibodies), or PARP inhibitors.
    • Patients with a "currently active" second invasive malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and have been free of disease for ≥ 1 years.
    • Patients with known and untreated or progressing brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients whose brain metastases have been treated with surgery and/or radiotherapy and are without evidence of progression on scan for at least 4 weeks, and are off steroids or antiseizure medications, will be eligible .
    • Patients with symptomatic or impending spinal cord compression are not eligible unless appropriately treated.
    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab or rucaparib.
    • Based on in vitro CYP interaction studies, caution should be used for concomitant medications with a narrow therapeutic window that are substrates of CYP2C19, CYP2C9, and/or CYP3A. Selection of an alternate concomitant medication is recommended. Caution should also be exercised for concomitant use of certain statin drugs (e.g. rosuvastatin and fluvastatin) due to potential increase in exposure from inhibition of BCRP and CYP2C9. An updated list of clinically relevant P450 drug interactions (e.g: Flockhart Table http://medicine.iupui.edu/clinpharm/ddis/main-table/) should be reviewed while screening patients for study.
    • Patients taking warfarin should have international normalized ration (INR) monitored regularly according to standard institutional practices
    • Because rucaparib is a moderate inhibitor of P-gp in vitro, caution should be exercised for patients receiving rucaparib and requiring concomitant medication with digoxin. Patients taking digoxin should have their digoxin levels monitored after starting rucaparib and then regularly per standard clinical practice.
    • Patients on parenteral nutrition are not eligible. Patients must not have a pre-existing duodenal stent or any gastrointestinal disorder or defect that would, in the opinion of the treating investigator, interfere with absorption of rucaparib.
    • Uncontrolled intercurrent illness including, but not limited to, requirement for oxygen therapy, ongoing or active infection other than minor urinary tract infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
    • Known history of chronic hepatitis B or C as evidenced by:
    • Positive test for hepatitis B surface antigen
    • Positive test for qualitative hepatitis C viral load (by polymerase chain reaction [PCR])
    • Note: Subjects with positive hepatitis C antibody and negative quantitative hepatitis C by polymerase chain reaction (PCR) are eligible.
    • Human Immunodeficiency Virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with rucaparib. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
    • Prior organ allograft or allogeneic bone marrow transplantation.
    • Adverse effect of prior therapy not improved to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or below with the exception of alopecia or lymphopenia. Ongoing Grade 2 non-hematologic toxicity (e.g. neuropathy) related to most recent treatment regimen may be permitted with prior advanced approval from the Lead Principal Investigator.
    • Initiated denosumab or bisphosphonate therapy or adjusted denosumab or bisphosphonate dose/regimen within 4 weeks prior to first dose of rucaparib. Patients on a stable denosumab or bisphosphonate regimen are eligible and may continue treatment.
    • Evidence or history of active or latent tuberculosis infection including purified protein derivative (PPD) recently converted to positive.
    • Use of non-oncology vaccines containing live virus for prevention of infectious diseases within 12 weeks prior to study drug. The use of inactivated seasonal influenza vaccines, e.g., Fluzone®, will be permitted on study without restriction.

    Contact:

    • Jaclyn Peterson
    • 773-834-1746

    Location:

    • University of Chicago Medical Center
    • Chicago Illinois 60637 United States

    View trial on ClinicalTrials.gov


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    Published February 7, 2019
  • A Phase II Randomized Control Trial of Conventional Versus Hypofractionated Radiation Regimen in Single Phase Using IMRT Technique and Long Term Androgen Suppression Therapy in High-risk Prostate Cancer Patients.

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    A Phase II Randomized Control Trial of Conventional Versus Hypofractionated Radiation Regimen in Single Phase Using IMRT Technique and Long Term Androgen Suppression Therapy in High-risk Prostate Cancer Patients.


    Condition: High-risk Prostate Cancer

    Intervention:

    • Radiation: Standard Radiation Treatment
    • Radiation: Hypofractionated radiation treatment

    Purpose: Hypofractionated regimen in high-risk prostate cancer will allow the investigators to deliver higher biological doses to targets in order to improve tumor control and with acceptable rectal toxicity compared to conventional fractionation.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01488968

    Sponsor: AHS Cancer Control Alberta

    Primary Outcome Measures:

    • Measure: The rate of late rectal toxicities between hypofractionated versus conventional fractionated schedules in high risk prostate cancer patients
    • Time Frame: 5 years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: The biochemical control (freedom from PSA failure) rate
    • Time Frame: 10 years
    • Safety Issue:
    • Measure: Disease free survival
    • Time Frame: 10 years
    • Safety Issue:

    Estimated Enrollment: 134

    Study Start Date: March 2012

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Patient is 18 years of age or older
    • Patient has histologically proven adenocarcinoma of prostate gland by needle core samples or TURP with assigned Gleason score. Prostate biopsy performed within 180 days of enrollment (date of consent).
    • Patient has high-risk prostate cancer (stage T3 or T4) and/or PSA greater than or equal to 20 ng/ml and/or Gleason score 8 to 10
    • No clinical or radiological evidence of nodal or distant metastasis(es).
    • In the opinion of the treating oncologist, patient is fit to undergo radical external beam radiotherapy to the prostate. Patients are accessible for treatment and follow up.
    • Patient does not have history of inflammatory bowel disease, anal stenosis, colorectal surgery, or repeated endoscopic examinations/interventions related to anorectal diseases.
    • No history of prostatectomy, transurethral resection of prostate on more than one occasion or previous pelvic radiotherapy.
    • No history of androgen suppression for greater than or equal to 6 months and patient is willing for androgen suppression treatment as per standard or at physician's discretion.
    • No previous malignancy within last five years except BCC or SCC skin or highly curable malignancy where a prognosis for cure is > 80%.
    • Patient signed informed consent.

    Contact:

    • Albert Murtha
    • 780-432-8518

    Location:

    • Cross Cancer Institute
    • Edmonton Alberta T6G 1Z2 Canada

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • A Phase II Randomized Trial Evaluating Acute and Late Toxicity of High-Dose Rate Brachytherapy and Low-Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer

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    A Phase II Randomized Trial Evaluating Acute and Late Toxicity of High-Dose Rate Brachytherapy and Low-Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer


    Condition: Prostate Cancer

    Intervention:

    • Radiation: Permanent Iodine-125 seed implant
    • Radiation: High-Dose-rate Prostate Brachytherapy

    Purpose: High-dose rate brachytherapy (HDRB) used as monotherapy is emerging as an alternative to Low-Dose Rate brachytherapy (LDRB) with excellent PSA-progression free survival as high as 90-100% for favorable prostate cancer at a median follow-up of 3-5 years. HDRB has many advantages over LDRB such as prospective dosimetry not impacted by setup errors, organ motion and prostate swelling during treatment delivery. In addition, HDRB causes less acute and late urinary toxicity compared with LDRB. Acute urinary retention can lead to prolonged catheterization, pericatheter urine leakage, urinary tract infection and Trans-Urethral Resection of the Prostate resulting in diminished quality of life (QOL) and increased psychological distress. The goal of the investigators' phase II randomized study is to evaluate the differences in QOL in the urinary domain between patients with favourable intermediate risk or extensive low-risk prostate cancer treated with LDRB and HDRB at 3 months using the Expanded Prostate Cancer Index Composite (EPIC) QOL scores. The 3 months cut-off endpoint has been chosen since HDRB-induced urinary toxicity subsides at 12 weeks compared to 12 months with LDRB. Secondary objectives include: bowel and sexual domain EPIC scores and International Prostate Symptom Score. The absolute PSA nadir and a prostate biopsy at 36 months will be reported to assess local control.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02628041

    Sponsor: CHU de Quebec-Universite Laval

    Primary Outcome Measures:

    • Measure: Quality of Life differences at 3 months using the Expanded Prostate Cancer Index Composite in the urinary domain.
    • Time Frame: 3 months
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Quality of life differences using the Expanded Prostate Cancer Index Composite (EPIC) score in the bowel and sexual domain at baseline, 1, 3, 6, 12, and 24 months.
    • Time Frame: 24 months
    • Safety Issue:
    • Measure: Differences in urinary function using the International Prostate Symptom Score which, will be filled in by the patient at baseline, 1, 3, 6, 12 and 24 months after the procedure.
    • Time Frame: 24 months
    • Safety Issue:
    • Measure: Acute and long-term urinary, sexual and gastro-intestinal toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 at each patient's visit.
    • Time Frame: 24 months
    • Safety Issue:
    • Measure: The dose to the bladder neck defined as 5 mm around the Foley catheter from the bottom of the Foley balloon to the prostatic urethra with a volume of at least 2 cc.
    • Time Frame: 1month
    • Safety Issue:
    • Measure: Local control by performing transrectal-ultrasound guided 12-core prostate rebiopsy at 36 months to assess treatment outcome.
    • Time Frame: 36 months
    • Safety Issue:
    • Measure: The absolute PSA nadir value will be reported as a secondary objective by PSA measurements every 6 months after the procedure.
    • Time Frame: every 6 months up to 5 years
    • Safety Issue:

    Estimated Enrollment: 30

    Study Start Date: October 2015

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    1. -Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months. Patients on active surveillance with evidence of disease progression are eligible to the protocol as long as they meet the

    Eligibility Criteria:

    • and have a recent prostate biopsy (within 9 months).
    • Low-risk disease defined as: Clinical stage T1-T2 and Gleason 6 and PSA≤20 ng/mL.
    • Intermediate-risk disease defined as: Clinical stage T1-T2 and Gleason 7 (3+4) and PSA ≤ 20 ng/mL and ≤ 60% of positive cores.
    • Lymph node evaluation by either CT or MRI is optional and is left at the discretion of the treating physician.
    • No alpha reductase inhibitors use within 2 weeks of randomization. A washout period of 2 weeks is required prior to randomization.
    • Eastern Cooperative Oncology Group status 0-1
    • No hormonal therapy is accepted.
    • Prostate volume by Trans-rectal Ultrasound (TRUS) ≤ 60 cc.
    • Internation Prostate Symptom Score (IPSS) ≤ 20 (alpha blockers allowed)

    Exclusion Criteria:

    • Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
    • Prior or current bleeding diathesis
    • Previous androgen deprivation therapy within 6 months of the registration.
    • Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior chemotherapy for prostate cancer, prior Transurethral resection of the prostate (TURP), prior cryosurgery of the prostate.
    • Evidence of metastatic disease (radiology investigations at the discretion of the treating physician).
    • Any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision).
    • Gleason score 7 (4+3), clinical stage≥ T3a, PSA > 20 and > 60% of positive cores.

    Location:

    • CHU de Québec- L'Hôtel-Dieu de Québec
    • Québec Quebec G1R 2J6 Canada

    View trial on ClinicalTrials.gov


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    Published January 10, 2017
  • A Phase II Randomized, Open-Label, Two-Arm Study of a Low-Fat Diet With Fish Oil Capsules vs. a Control Group in Men on Active Surveillance for Prostate Cancer

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    A Phase II Randomized, Open-Label, Two-Arm Study of a Low-Fat Diet With Fish Oil Capsules vs. a Control Group in Men on Active Surveillance for Prostate Cancer


    Condition: Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

    Intervention:

    • Behavioral: behavioral dietary intervention
    • Behavioral: behavioral dietary intervention
    • Dietary Supplement: omega-3 fatty acid
    • Other: laboratory biomarker analysis

    Purpose: This randomized phase II trial will evaluate if a low-fat diet with fish oil has the potential to delay disease progression in patients with prostate cancer undergoing active surveillance.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02176902

    Sponsor: Jonsson Comprehensive Cancer Center

    Primary Outcome Measures:

    • Measure: Decipher score in one year prostate biopsy tissue sample
    • Time Frame: 1 year
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Composite measure: Prostate biopsy tissue markers of proliferation, cell cycle progression, and prostate biopsy pathologic features (Gleason grade, percent of cores with cancer, and percent of tissue with cancer)
    • Time Frame: 1 year
    • Safety Issue:
    • Measure: Serum PSA
    • Time Frame: Up to 1 year
    • Safety Issue:
    • Measure: Composite measure: Long-term clinical outcomes (clinical progression, prostate cancer therapies)
    • Time Frame: Up to 15 years
    • Safety Issue:
    • Measure: Composite measure: Potential surrogate biomarkers of proliferation (RBC membrane fatty acid analyses, ex-vivo bioassay)
    • Time Frame: Up to 1 year
    • Safety Issue:
    • Measure: Correlation of GPR120 expression in peripheral blood mononuclear cells (PBMCs) and prostate biopsy tissue with immunostaining of Ki67 and Decipher Score
    • Time Frame: Up to 1 year
    • Safety Issue:
    • Measure: Compliance, defined as having taken 80% or more of the daily fish oil throughout the trial determined based on pill count
    • Time Frame: Up to 1 year
    • Safety Issue:
    • Measure: Incidence of adverse events graded according to National Cancer Institute Common Toxicity Criteria version 4.0
    • Time Frame: Up to 1 year
    • Safety Issue:
    • Measure: Sample storage for future research
    • Time Frame: Up to 1 year
    • Safety Issue:

    Estimated Enrollment: 100

    Study Start Date: November 1, 2014

    Eligibility:

    • Age: minimum 50 Years maximum 80 Years
    • Gender: Male

    Inclusion Criteria:

    • Patients sign the informed consent
    • Patient had a prostate biopsy performed by Dr. Mark with the Artemis device and has adenocarcinoma of the prostate
    • Patient elects to undergo active surveillance
    • Clinical stage T2c or less
    • Gleason grade 3+4 or less
    • PSA < 20
    • Geographically able to have study visits at the University of California, Los Angeles (UCLA) Clinical Research Unit
    • Subjects are willing to not consume lycopene, green tea or pomegranate supplements or pomegranate juice during the 1-year study
    • If subjects are randomized to the control group they agree to not consume fish oil capsules during the 1-year study

    Exclusion Criteria:

    • Diagnostic prostate biopsy with only 1 core with cancer and < 5% of tissue from that core involved with cancer
    • Patient has taken finasteride or dutasteride during the prior year
    • Patient has taken fish oil during the prior 3 months
    • Patient had prior treatment for prostate cancer (surgery, radiation, local ablative therapy, anti-androgen therapy or androgen deprivation therapy)
    • Patient has other medical conditions that exclude him from undergoing a repeat prostate biopsy at 1-year
    • Patient has allergy to fish

    Location:

    • Jonsson Comprehensive Cancer Center
    • Los Angeles California 90095 United States

    View trial on ClinicalTrials.gov


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    Published June 4, 2018
  • A Phase II Study of 68Ga-RM2 for PET/CT of Gastrin Releasing Peptide Receptor (GRPr) Expression in Prostate Cancer

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    A Phase II Study of 68Ga-RM2 for PET/CT of Gastrin Releasing Peptide Receptor (GRPr) Expression in Prostate Cancer


    Condition: Prostate Cancer

    Intervention:

    • Radiation: 68Ga-RM2 (RM2)
    • Device: PET/CT Scan

    Purpose: The purpose of this study is to see if a new diagnostic research agent named 68Ga-RM2 can show prostate cancer on a PET/CT scan. 68Ga-RM2 stands for Galium-68 labeled DOTA-4-amino-1-carboxymethylpiperidine-D-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2. This study is being done because there are unmet medical needs to improve the current ways of detecting prostate cancers before surgery.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02559115

    Sponsor: Memorial Sloan Kettering Cancer Center

    Primary Outcome Measures:

    • Measure: localizing tumors
    • Time Frame: within two weeks prior to the planned prostatectomy
    • Safety Issue:

    Estimated Enrollment: 20

    Study Start Date: September 2015

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Age ≥18 years
    • Biopsy proven adenocarcinoma of the prostate
    • Patients with low-risk, intermediate-risk and high-risk tumors according to NCCN guidelines (2.2014) will be included
    • Planned radical prostatectomy at MSKCC
    • Multiparametric MRI of the pelvis (performed or planned) as routine care Exclusion Criteria:
    • Patients meeting any of the following

    Exclusion Criteria:

    • Patients meeting any of the following exclusion criteria will not be eligible for study entry:
    • Hematologic
    • Platelets <75K/mcL
    • ANC <1.0 K/mcL
    • Hepatic laboratory values
    • Bilirubin >2.0 x ULN (institutional upper limits of normal)
    • AST/ALT >2.5 x ULN
    • Renal laboratory values o Creatinine > 2.0 x ULN
    • Claustrophobia interfering with MRI and PET/CT imaging
    • Prior pelvic radiation
    • Prior androgen deprivation therapy
    • Patients deemed not surgical candidates due to prohibitive co-morbidities

    Contact:

    • Herbert Vargas Alvarez, MD
    • 646-888-5410

    Location:

    • Memorial Sloan Kettering Cancer Center
    • New York New York 10065 United States

    View trial on ClinicalTrials.gov


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    Published January 12, 2017
  • A Phase II Study of Docetaxel Before Medical Castration With Degarelix in Patients With Newly Diagnosed Metastatic Prostatic Adenocarcinoma.

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    A Phase II Study of Docetaxel Before Medical Castration With Degarelix in Patients With Newly Diagnosed Metastatic Prostatic Adenocarcinoma.


    Condition: Metastatic Prostatic Adenocarcinoma

    Intervention:

    • Drug: Docetaxel
    • Drug: Degarelix

    Purpose: The purpose of this study is to look at patient outcomes when docetaxel is started prior to ADT with degarelix.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03069937

    Sponsor: Medical University of South Carolina

    Primary Outcome Measures:

    • Measure: PSA response at 10 months
    • Time Frame: 10 months
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: PSA response at 6 months
    • Time Frame: 6 months
    • Safety Issue:
    • Measure: Frequency of adverse events (AEs) using CTCAE v. 4
    • Time Frame: 10 months
    • Safety Issue:
    • Measure: Frequency of disease progression at 12 weeks using PSA
    • Time Frame: 12 weeks
    • Safety Issue:
    • Measure: PSA response at 12 weeks
    • Time Frame: 12 weeks
    • Safety Issue:
    • Measure: Development of castration resistance after initiation with ADT
    • Time Frame: 10 months
    • Safety Issue:
    • Measure: Progression free survival
    • Time Frame: 34 months
    • Safety Issue:
    • Measure: Overall survival (OS)
    • Time Frame: 34 months
    • Safety Issue:

    Estimated Enrollment: 53

    Study Start Date: March 1, 2017

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    1. Patients eligible for study participation must meet all of the following criteria.
    2. Histological or cytological diagnosis of adenocarcinoma of the prostate.
    3. Metastatic disease identified via radiographic assessment by CT scans of the chest, abdomen, pelvis, and nuclear bone scan. MRI may be used if deemed necessary by the investigator. See Section 8.5 for more details about radiographic assessment requirements. More specifically, patients must have at least one of the following at time of study enrollment:
    4. Any visceral metastases identified by CT scans or MRI.
    5. Site(s) of bony metastasis identified by nuclear bone scan, MRI, and/or CT scan.
    6. Lymph node based disease not considered to be within a single radiation therapy port (e.g. at or above the aortic bifurcation.)
    7. Non-castrate testosterone level, >50 ng/dl, at study enrollment.
    8. Age greater than or equal to 18 years.
    9. ECOG performance status 0-
    10. Meet the following hematologic criteria within 14 days of enrollment to trial:
    11. Absolute neutrophil count > 1,500/mm3
    12. Hemoglobin > 8.0 g/dl (may be transfused)
    13. Platelet count > 100,000 mm3
    14. Have adequate end-organ function as defined by the following parameters. All lab values must be obtained within 14 days of enrollment to trial:
    15. Creatinine clearance of > 30 ml/min. Creatinine clearance should be determined by the Cockcroft-Gault formula (Appendix A)
    16. AST < 2 x institutional ULN
    17. ALT < 2 x institutional ULN
    18. Total bilirubin < institutional ULN
    19. Agree to use barrier methods of birth control during the docetaxel portion of the protocol and for at least one month after last docetaxel administration.
    20. Informed and must sign and give written informed consent in accordance with institutional and federal guidelines.

    Exclusion Criteria:

    1. Patients eligible for study participation CANNOT meet any of the following criteria:
    2. CNS metastases (brain or leptomeningeal).
    3. Osseous metastases felt in the opinion of the clinician to be high-risk for impending pathologic fracture or spinal cord compression.
    4. Active cardiac disease defined as symptomatic congestive heart failure, history of NYHA Class III or IV Heart Failure, uncontrollable supraventricular arrhythmias, any history of a ventricular arrhythmia, active angina pectoris, myocardial infarction or coronary intervention within 6 months of registration.
    5. Prior malignancy requiring systemic therapy within the last 5 years except for treated basal or squamous cell skin cancer. History of low-grade malignancies with limited potential to progress as determined by the primary investigator may be enrolled.
    6. Subjects must not have received any previous androgen deprivation therapy (LHRH agonist or LHRH antagonist) or cytotoxic therapy for prostate cancer in the metastatic setting. Exception Patients may have received no more than 30 days of anti-androgen (e.g. bicalutamide) in the metastatic setting prior to the start of study treatment.
    7. Subjects must not have had more than 36 months of hormonal therapy in combination with prostatectomy or radiation in the setting of localized disease and must not have shown any evidence of disease recurrence within 12 months after stopping hormonal therapy. Disease recurrence after hormonal therapy is defined as PSA > 0.2ng/dl after prostatectomy + hormonal therapy or PSA that is 2.0ng/dl more than the PSA nadir after radiotherapy + hormonal therapy. Previous hormonal therapy to the prostate must have stopped at least 12 months prior to enrollment.
    8. Subjects must not have been treated with prior docetaxel in the setting of metastatic prostate cancer. Subjects may have been treated with docetaxel in the setting of localized prostate cancer (likely as a trial-based neoadjuvant or adjuvant approach to prostatectomy or radiation.) Subjects treated with this approach must not have shown any evidence of disease recurrence within 12 months after stopping docetaxel. Disease recurrence after docetaxel is defined as PSA > 0.2ng/dl after prostatectomy + docetaxel or PSA that is 2.0ng/dl more than the PSA nadir after radiotherapy +docetaxel. Previous docetaxel in the setting of localized prostate cancer must have stopped at least 12 months prior to study enrollment.
    9. Palliative radiation therapy may have been received but not within the 30 days prior to study treatment.
    10. Presence of peripheral neuropathy > Grade
    11. Known HIV-positive
    12. Presence of any severe or uncontrolled concurrent medical condition felt in the opinion of the investigator to increase the risk of serious toxicity from the study therapy.
    13. Prior hypersensitivity to any of the components of the study drugs.

    Contact:

    • Mike Wheeler
    • 843-792-9321

    Location:

    • Medical University of South Carolina
    • Charleston South Carolina 29425 United States

    View trial on ClinicalTrials.gov


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    Published September 7, 2017
  • A Phase II Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Metastatic Castration Resistant Prostate Cancer

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    A Phase II Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Metastatic Castration Resistant Prostate Cancer


    Condition: Prostate Cancer

    Intervention:

    • Drug: Durvalumab
    • Drug: Tremelimumab

    Purpose: The purpose of this study is to find out the effects of giving durvalumab alone or in combination with tremelimumab on this type of cancer. In addition, this study will look at the side effects of durvalumab when given alone or in combination with tremelimumab.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02788773

    Sponsor: Canadian Cancer Trials Group

    Primary Outcome Measures:

    • Measure: Objective response rate measured by RECIST 1.1 and iRECIST
    • Time Frame: 2 years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Response rate as time to PSA progression
    • Time Frame: 2 years
    • Safety Issue:
    • Measure: Objective Disease progression
    • Time Frame: 2 years
    • Safety Issue:
    • Measure: Number and severity of adverse events
    • Time Frame: 2 years
    • Safety Issue:

    Estimated Enrollment: 74

    Study Start Date: August 18, 2016

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Patients must have histologically confirmed adenocarcinoma of the prostate that is castrate resistant.
    • Disease progression as defined as one or both of the following: PSA Progression: A rising PSA with 2 subsequent rises over a reference value (not necessarily consecutively), measured a minimum of one week apart. The PSA that confirms progression must have a value of ≥ 2 ng/ml (ug/L). OR Objective Progression:
    • RECIST 1.1
    • PCWG 3 Criteria for bone progression
    • Patients must be surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 1.7 nM). Patients who have not undergone orchiectomy must continue (or restart if previously discontinued) LHRH therapy throughout the study.
    • All patients must have a tumour block from their primary or metastatic tumour available and consent to release the block/recently cut slides for correlative analyses and the centre/pathologist must have agreed to the submission of the specimen(s). The site of planned biopsy must not be the measurable lesion.
    • Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 28 days prior to randomization (within 35 days if negative).
    • All patients must have at least one measurable lesion as defined by RECIST 1.1 that has not been the site of the protocol mandated biopsy. The criteria for defining measurable disease are as follows: CT scan (with slice thickness of 5 mm) ≥ 10 mm --> longest diameter; Lymph nodes by CT scan ≥ 15 mm --> measured in short axis
    • Patients must be ≥ 18 years of age.
    • ECOG performance status 0 or 1.
    • Prior Therapy Systemic Therapy: 0-1 prior regimen of cytotoxic chemotherapy in the CRPC setting is permitted. Hormonal Therapy:
    • Patients must be castrate resistant.
    • Have failed/progressed on prior abiraterone and/or enzalutamide.
    • Patients must have discontinued anti-androgens for at least 4 weeks prior to study entry (at least 6 weeks for bicalutamide). Other therapy: Prior treatment with other agents, such as tyrosine kinase or other targeted agents is permissible.
    • Systemic corticosteroids are permitted at a dose equivalent to ≤10 mg prednisone daily and are only permitted for reasons other than prostate cancer treatment (ex: fatigue, anorexia, etc); topical applications (e.g. rash), inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intra-articular) are permitted.
    • Bisphosphonates/denosumab are permitted for treatment of hypercalcemia, osteoporosis and skeletal-related events. Immunotherapy: Patients may not have received prior immune check point inhibitors (anti PDL1 and anti CTL-4). Vaccines and treatment with oncolytic viruses is permissible. Patients must have recovered from all reversible toxicity related to prior systemic therapy (chemotherapy and hormone) and have adequate washout as follows: Longest of one of the following:
    • Two weeks;
    • The longer of 30 days or 5 half-lives for investigational agents;
    • Standard cycle length of standard therapies. Radiation: Prior external beam radiation or radium-223 is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and the date of randomization. Exceptions may be made for low-dose non-myelosuppressive radiotherapy after consultation with CCTG. Concurrent radiotherapy is not permitted. Prior strontium-89 at any time is not permitted Prior Surgery: Prior major surgery is permitted provided that a minimum of 28 days (4 weeks) have elapsed between any major surgery and date of randomization, and that wound healing has occurred.
    • Laboratory Requirements (Must be done within 7 days prior to randomization): Abs Neutrophils ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Hemoglobin ≥ 90 g/L Bilirubin ≤ 1.5 x ULN AST and ALT ≤ 2.5 x ULN ≤ 5.0 ULN (if patient has liver mets) Serum Creatinine < 1.25 x ULN or Creatinine clearance ≥ 40mL/min
    • Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use male condom plus spermicide while on study and for 6 months after the last dose of durvalumab and tremelimumab, or for 3 months after the last dose of durvalumab alone. Female partners of a male subject must use a highly effective method of contraception throughout this period.
    • Male patients should also refrain from donating sperm during the study and for 6 months after the last dose of durvalumab and tremelimumab or for 3 months after the last dose of durvalumab alone.
    • Subjects should not donate blood while participating in this study, or for at least 90 days following the last infusion of durvalumab or tremelimumab.
    • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. Patients who cannot give informed consent (i.e. mentally incompetent patients, or those physically incapacitated such as comatose patients) are not to be recruited into the study. Patients competent but physically unable to sign the consent form may have the document signed by their nearest relative or legal guardian. Each patient will be provided with a full explanation of the study before consent is requested.
    • Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial. The patient's city of residence may be required to verify their geographical proximity. Investigators must assure themselves the patients registered on this trial will be available for complete documentation of the tretment, adverse events, and follow-up.
    • Patients must agree to return to their primary care facility for any adverse events which may occur through the course of the trial.
    • In accordance with CCTG policy, protocol treatment is to begin within 5 working days of patient randomization.

    Exclusion Criteria:

    • Patients with a history of other malignancies requiring concurrent anticancer therapy.
    • Patients with brain metastases are not eligible.
    • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease (e.g. colitis or Crohn's disease), diverticulitis with the exception of diverticulosis, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), rheumatoid arthritis, hypophysitis, uveitis, etc., within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:
    • Patients with alopecia.
    • Patients with Grave's disease, vitiligo or psoriasis not requiring systemic treatment (within the last 2 years).
    • Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement.
    • History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy or grade ≥ 3 infusion reaction.
    • Live attenuated vaccination administered within 30 days prior to randomization or within 30 days of receiving durvalumab.
    • History of hypersensitivity to durvalumab or tremelimumab or any excipient. Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab or an anti-CTLA4, including tremelimumab.
    • Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, should have a LVEF ≥ 50%.
    • Concurrent treatment with other investigational drugs or anti-cancer therapy (except LHRH in patients not surgically castrated).
    • Patients with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol (including corticosteroid administration), or would put the patient at risk. This includes but is not limited to:
    • History of significant neurologic or psychiatric disorder which would impair the ability to obtain consent or limit compliance with study requirements.
    • Active infection requiring systemic therapy; (including any patient known to have active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) or tuberculosis or any infection requiring systemic therapy).
    • Active peptic ulcer disease or gastritis.
    • Pneumonitis.

    Contact:

    • Lesley Seymour
    • 613-533-6430

    Locations:

    • BCCA - Cancer Centre for the Southern Interior
    • Kelowna British Columbia V1Y 5L3 Canada
    • BCCA - Vancouver Cancer Centre
    • Vancouver British Columbia V5Z 4E6 Canada
    • CancerCare Manitoba
    • Winnipeg Manitoba R3E 0V9 Canada
    • Juravinski Cancer Centre at Hamilton Health Sciences
    • Hamilton Ontario L8V 5C2 Canada
    • Kingston Health Sciences Centre
    • Kingston Ontario K7L 2V7 Canada
    • London Regional Cancer Program
    • London Ontario N6A 5W9 Canada
    • Ottawa Hospital Research Institute
    • Ottawa Ontario K1H 8L6 Canada
    • Odette Cancer Centre
    • Toronto Ontario M4N 3M5 Canada
    • University Health Network
    • Toronto Ontario M5G 2M9 Canada
    • Allan Blair Cancer Centre
    • Regina Saskatchewan S4T 7T1 Canada
    • Saskatoon Cancer Centre
    • Saskatoon Saskatchewan S7N 4H4 Canada

    View trial on ClinicalTrials.gov


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    Published August 1, 2017
  • A Phase II Trial of Proton Radiation Therapy of Using Standard Fractionation for Low-and Low-Intermediate Risk Adenocarcinoma of the Prostate

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    A Phase II Trial of Proton Radiation Therapy of Using Standard Fractionation for Low-and Low-Intermediate Risk Adenocarcinoma of the Prostate


    Condition: Prostate Cancer

    Intervention:

    • Procedure: Proton Beam Radiation Therapy
    • Other: Quality-of-Life assessment
    • Other: Questionnaire Administration

    Purpose: RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This clinical trial is studying how well proton radiation therapy works in treating patients with prostate cancer.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01045226

    Sponsor: Abramson Cancer Center of the University of Pennsylvania

    Primary Outcome Measures:

    • Measure: As a feasibility precaution patients will be treated and followed for a minimum of 60 days after completion of radiotherapy to determine feasibility
    • Time Frame: 5 years
    • Safety Issue:
    • Measure: Acute toxicity as assessed by NCI CTC Version 3.0
    • Time Frame: Within 60 or 90 days from completion of radiotherapy
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Late toxicity as assessed by RTOG/EORTC late morbidity scoring system
    • Time Frame: More than 60 or 90 days from completion of radiotherapy
    • Safety Issue:
    • Measure: Biochemical/clinical progression-free survival
    • Time Frame: Time from start of radiotherapy to either documented increase in PSA or clinical progression of disease, death due to any cause or last patient contact alive
    • Safety Issue:
    • Measure: Estimation of event rates
    • Safety Issue:

    Estimated Enrollment: 262

    Study Start Date: August 2009

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Histologically confirmed prostate adenocarcinoma within 365 days of registration
    • Clinical stages T1a-T2a N0 M0
    • For any pelvic lymph node >= 1.5cm, biopsy of the lymph node is mandatory
    • Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range 2-6; > 6 cores is strongly recommended; the highest Gleason score in any core reported on the pathology report will be used for determining inclusion
    • PSA values < 10 ng/ml within 90 days prior to registration, done either prior to prostate biopsy or at least 21 days after prostate biopsy.
    • Alkaline phosphatase within 60 days prior to registration. If alkaline phosphatase is elevated > 2 x the upper limit of institutional normal (UNL), patient must have radiological correlation to assess for metastases
    • Zubrod status 0-1 documented within 60 days of registration
    • Prior androgen deprivation is allowed; however, androgen deprivation will not be continued concurrently or as an adjuvant therapy
    • Patients must give IRB-approved study-specific informed consent
    • Patients must complete all required tests listed within the specified time frames
    • Patients must be able to start treatment within 56 days of registration
    • Members of all races and ethnic groups are eligible for this trial

    Exclusion Criteria:

    • Clinical stages T2c or greater
    • PSA of 10 ng/ml or greater
    • Gleason score 7 or higher
    • Evidence of distant metastasis
    • Evidence of lymph node involvement
    • Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery
    • Previous pelvic radiation for prostate cancer
    • Androgen deprivation therapy prior to radiation is allowed; however, it is not acceptable if continued during radiation or as adjuvant therapy
    • Active rectal diverticulitis, Crohn's disease, or ulcerative colitis are not allowed
    • Prior systemic chemotherapy for prostate cancer
    • History of proximal urethral stricture requiring dilatation

    Contact:

    • Neha Vapiwala, MD
    • 855-216-0098

    Location:

    • Abramson Cancer Center of the University of Pennsylvania
    • Philadelphia Pennsylvania 19104 United States

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • A Phase II Trial of Proton Radiation Therapy or Intensity-Modulated Radiation Therapy Using Mild Hypofractionation for Low-and Intermediate -Risk Adenocarcinoma of the Prostate

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    A Phase II Trial of Proton Radiation Therapy or Intensity-Modulated Radiation Therapy Using Mild Hypofractionation for Low-and Intermediate -Risk Adenocarcinoma of the Prostate


    Condition: Prostate Adenocarcinoma

    Intervention:

    • Radiation: Proton Therapy
    • Radiation: IMRT

    Purpose: This is a study to first establish feasibility of the study and then to register the treatment data of adult patients with a diagnosis of intermediate risk of prostate cancer presenting for definitive radiation treatment with either proton radiotherapy or Intensity Modulated Radiation Therapy (IMRT). The investigators propose to employ a hypofractionated strategy with our image guided treatment to further improve cancer control and decrease toxicity.

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT01352429

    Sponsor: Abramson Cancer Center of the University of Pennsylvania

    Primary Outcome Measures:

    • Measure: Number of Participants with Adverse Events
    • Time Frame: Within 10 days
    • Safety Issue:
    • Measure: Acute Toxicity
    • Time Frame: Within 60 days of completion of radiotherapy
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Late toxicity
    • Time Frame: open-ended
    • Safety Issue:
    • Measure: Biochemical/clinicalprogression-free survival
    • Time Frame: 5 years
    • Safety Issue:

    Estimated Enrollment: 200

    Study Start Date: August 2009

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    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Histologically confirmed prostate adenocarcinoma within 365 days of registration.
    • Clinical stages T1a-T2c N0 M0 (AJCC Criteria 6th Ed). For any suspicious pelvic lymph node > 1.5cm (as exhibited on pelvic imaging), biopsy of the lymph node is suggested.
    • Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range 2-7. Biopsy with > 6 cores is strongly recommended. (The highest Gleason Score in any core reported on the pathology report will be used for determining inclusion.)
    • PSA values <20 ng/ml within 90 days prior to registration, and done either prior to prostate biopsy, or at least 21 days after prostate biopsy.
    • Zubrod (ECOG) status 0-1 documented within 90 days of registration.
    • Androgen deprivation is at the discretion of the treating radiation oncologist.
    • Subjects must give IRB-approved study-specific informed consent. Subjects must complete all required tests within the specified time frames.
    • Subjects must be at least 18 years old.
    • Members of all races and ethnic groups are eligible for this trial.

    Exclusion Criteria:

    • Clinical stages T3 or greater (AJCC Criteria 6th Ed).
    • PSA of 20 ng/ml or greater.
    • Gleason score 8 or higher.
    • Evidence of distant metastasis. (Determined by CT scan, MRI, and/or bone scan prior to the simulation appointment; imaging results from UPHS will supercede results from similar scans from an outside facility.)
    • Evidence of lymph node involvement.
    • Previous prostate cancer surgery to include: prostatectomy, hyperthermia, and cryosurgery.
    • Previous pelvic radiation for prostate cancer.
    • Active rectal diverticulitis, Crohn's disease, or ulcerative colitis.
    • Prior systemic chemotherapy for prostate cancer.
    • History of proximal urethral stricture requiring dilatation.

    Contact:

    • Neha Vapiwala, MD
    • 855-216-0098

    Location:

    • Abramson Cancer Center of the University of Pennsylvania
    • Philadelphia Pennsylvania 19004 United States

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • A Phase II, Prospective Study of MRI in the Reclassification of Men Considering Active Surveillance in Prostate Cancer

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    A Phase II, Prospective Study of MRI in the Reclassification of Men Considering Active Surveillance in Prostate Cancer


    Condition: Prostate Cancer

    Intervention:

    • Device: Multiparametric MRI
    • Procedure: Prostate biopsy

    Purpose: Some men newly diagnosed with prostate cancer do not require immediate treatment. Rather, they can be followed closely with regular physical exams, blood work and repeated biopsies of the prostate. If the prostate cancer is becoming more aggressive, curative treatment can be offered at that time. This strategy of delaying treatment until necessary is called active surveillance in prostate cancer. Active surveillance is a way of monitoring prostate cancer which aims to avoid or delay unnecessary treatment in men with less aggressive cancer. Prostate cancer can be slow growing and, for many men, the disease may never progress or cause any symptoms. In other words, many men with prostate cancer will never need any treatment. Treatments for prostate cancer may cause side effects which can affect your quality of life. By monitoring the cancer with regular tests, you can avoid or delay these side effects. Active surveillance is generally suitable for men with low risk early stage prostate cancer that is contained within the prostate gland (localized prostate cancer). If doctors had a better way of identifying who might be best suited for this approach, it would likely become more appealing for more men. In this study, the investigators are looking at how accurate a magnetic resonance imaging (MRI) scan is at identifying high-risk prostate cancer, which might make a man a poor candidate for active surveillance. To do this, the investigators are collecting data from the MRI scan of men and comparing it to a trans-rectal biopsy performed following the scan. The results of this study will help inform doctors how accurate the MRI is in identifying men who should not be on active surveillance.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01858688

    Sponsor: Dana-Farber Cancer Institute

    Primary Outcome Measures:

    • Measure: Number of participants who have an MP-erMRI finding suggestive of more aggressive disease relative to repeat 12 core TRUS biopsy
    • Time Frame: 2 years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Number of men who have an MP-erMRIs which appear to reclassify them to more extensive or aggressive disease
    • Time Frame: 2 years
    • Safety Issue:
    • Measure: Number of participants to report a change in their health status following the MP-erMRI and rebiopsy o
    • Time Frame: 2 Years
    • Safety Issue:
    • Measure: Report on the tumor grade and extent from the targeted biopsy relative to findings on the MP-erMRI
    • Time Frame: 2 years
    • Safety Issue:

    Estimated Enrollment: 130

    Study Start Date: June 2013

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Participants must meet the following criteria on screening examination to be eligible to participate in the study:
    • The subject will have histologically confirmed prostate cancer with all of the following features:
    • Minimum 10 core prostate biopsy showing histologically-confirmed prostate cancer within 12 months of enrollment reviewed by a pathologist from one of the DF/HCC associated hospitals
    • Gleason ≤3+3
    • No tertiary Gleason grade ≥4
    • ≤3 total cores positive
    • ≤50% of any given core involved with cancer
    • No evidence on biopsy of extracapsular extension
    • PSA within one month of enrollment: <10 ng/mL
    • Clinical stage: ≤T2a & N0 or NX & M0
    • The subject is able and willing to abide by the study protocol or cooperate fully with the investigator or designee
    • The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document
    • Age ≥18
    • Life expectancy of greater than 10 years
    • Ability to understand and the willingness to sign a written informed consent document.

    Exclusion Criteria:

    • Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
    • First diagnosis of prostate cancer > 12 months prior to enrollment
    • Prior prostate cancer-directed therapy including:
    • androgen deprivation therapy
    • radiation therapy to the prostate (external beam or brachytherapy)
    • cryotherapy
    • high-intensity focused ultrasound (HIFU)
    • chemotherapy for prostate cancer
    • Prior transurethral resection of prostate
    • Subject who is deemed by the treating physician to have a contraindication to definitive treatment
    • Subjects with a contraindication to an MRI including those with a pacemaker, ferromagnetic aneurysm clip, or cochlear implants
    • Subjects with a contraindication to receiving Gadolinium containing contrast for the MRI
    • Conditions which make repeat TRUS biopsies not feasible

    Contact:

    • Neil E Martin, MD
    • (617) 732-6433

    Locations:

    • Brigham and Women's Hospital
    • Boston Massachusetts 02215 United States
    • Dana Farber Cancer Institute
    • Boston Massachusetts 02215 United States

    View trial on ClinicalTrials.gov


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    Published January 10, 2017
  • A Phase IIA Exploratory, Randomized, Placebo-Controlled Trial of Pomegranate Fruit Extract/POMx™ in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance

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    A Phase IIA Exploratory, Randomized, Placebo-Controlled Trial of Pomegranate Fruit Extract/POMx™ in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance


    Condition: Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

    Intervention:

    • Other: Laboratory Biomarker Analysis
    • Other: Pharmacological Study
    • Other: Placebo
    • Drug: Pomegranate-Extract Pill

    Purpose: This randomized phase II trial studies pomegranate-extract pill in preventing tumor growth in patients with prostate cancer that is limited to a certain part of the body (localized), who have chosen observation as their treatment plan. The use of pomegranate-extract pill may slow disease progression in patients with localized prostate cancer.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02095145

    Sponsor: National Cancer Institute (NCI)

    Primary Outcome Measures:

    • Measure: Change in plasma IGF-1
    • Time Frame: Baseline to 12 months
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Change in Gleason grade
    • Time Frame: Baseline to 1 year
    • Safety Issue:
    • Measure: Change in levels of PFD constituents/metabolites
    • Time Frame: Baseline to up to 1 year
    • Safety Issue:
    • Measure: Change in plasma biomarker levels
    • Time Frame: Baseline to up to 1 year
    • Safety Issue:
    • Measure: Change in tissue biomarker levels
    • Time Frame: Baseline to up to 1 year
    • Safety Issue:
    • Measure: Change in tumor volume on prostate biopsy
    • Time Frame: Baseline to 1 year
    • Safety Issue:
    • Measure: Compliance, in terms of the number of pills missed
    • Time Frame: Up to 1 year
    • Safety Issue:
    • Measure: Incidence of adverse events graded per Common Terminology Criteria for Adverse Events (CTCAE)
    • Time Frame: Up to 1 year
    • Safety Issue:
    • Measure: Total serum PSA
    • Time Frame: Up to 1 year
    • Safety Issue:

    Estimated Enrollment: 30

    Study Start Date: May 8, 2014

    Phase: Phase 2

    Eligibility:

    • Age: minimum 21 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Participants must have had a standard-of-care biopsy within 13 months of the baseline study visit and must have been diagnosed with low-grade, clinically localized prostate cancer (Gleason score =< 3+3 with a PSA at baseline < 10 ng/ml in participants < 70 years of age, OR Gleason score =< 3+4 with a PSA at baseline =< 15 ng/ml in participants >= 70 years of age); eligible participants will be those men who are able and willing to undergo AS with PSA monitoring and a scheduled biopsy performed at the end of the study
    • No concurrent treatment (hormonal, radiation or systemic chemotherapy) for prostate cancer during study enrollment is planned (unless participants demonstrate clinical evidence of prostate cancer progression such as symptoms, physical exam findings, a rapidly increasing PSA, or radiologic findings which confirm disease progression)
    • Eastern Cooperative Oncology Group (ECOG) performance status =< 1
    • White blood cells (WBC) >= 3000/mm^3
    • Platelets >= 100,000 mm^3
    • Hemoglobin >= 10 g/dL
    • Total bilirubin =< 1.5 x upper limit of institutional normal
    • Alkaline phosphatase =< 1.5 x upper limit of institutional normal
    • Aspartate aminotransferase (AST) =< 1.5 x upper limit of institutional normal
    • Alanine aminotransferase (ALT) =< 1.5 x upper limit of institutional normal
    • Serum creatinine within 1.5 x upper limit of institutional normal
    • Sodium 135-144 mmol/L (inclusive)
    • Potassium 3.2-4.8 mmol/L (inclusive)
    • Participants will be required to use a medically-approved method of birth control or abstinence if their sexual partner is of child-bearing potential
    • Participants must be willing to forego foods, beverages and supplements containing pomegranate for the duration of the study
    • Ability to understand, and the willingness to sign, a written informed consent document

    Exclusion Criteria:

    • Any prior surgery to the prostate within 30 days of baseline procedures; NOTE: Biopsies are not considered surgeries
    • Evidence of other cancer(s) (excluding non-melanoma skin cancer) within last 5 years
    • Prior pelvic radiation for any reason
    • Participants cannot be taking 5-α-reductase inhibitors while on study or within 6 months of the baseline study visit
    • Participants may not be taking carbamazepine (Tegretol)
    • Participants may not be receiving any other investigational agents
    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to PFE
    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
    • Any significant cardiac event(s) within the 12 months prior to registration, such as episode(s) of symptomatic congestive heart failure, myocardial infarction, unstable angina pectoris or persistent, stable angina pectoris, or cardiac arrhythmia requiring medication

    Locations:

    • University of Alabama at Birmingham Cancer Center
    • Birmingham Alabama 35233 United States
    • Lahey Hospital and Medical Center
    • Burlington Massachusetts 01805 United States
    • University of Minnesota/Masonic Cancer Center
    • Minneapolis Minnesota 55455 United States
    • University of Rochester
    • Rochester New York 14642 United States
    • Urology San Antonio Research PA
    • San Antonio Texas 78229 United States
    • University of Wisconsin Hospital and Clinics
    • Madison Wisconsin 53792 United States

    View trial on ClinicalTrials.gov


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    Published January 10, 2017
  • A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation With Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate

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    A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation With Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate


    Condition: Prostate Cancer

    Intervention:

    • Radiation: Proton Radiation Hypofractionation
    • Radiation: Proton Radiation Standard Fractionation

    Purpose: The purpose of this study is to compare the effects (good and bad) on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks) with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of the treatments are similar or better.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01230866

    Sponsor: Proton Collaborative Group

    Primary Outcome Measures:

    • Measure: To assess if hypo-fractionation will result in 2-year freedom from failure (FFF) that is non-inferior to 2-year FFF following standard fractionation. FFF will be measured by recurrence, metastasis, PSA or start of salvage therapy.
    • Time Frame: At 5 years post treatment completion +/- 90 days
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: To determine the incidence of grade 2 or greater GU and GI toxicity in each of the regimens.
    • Time Frame: At 6 months and 2 years post randomization
    • Safety Issue:

    Estimated Enrollment: 150

    Study Start Date: November 2010

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Histologically confirmed prostate adenocarcinoma within 365 days prior to randomization.
    • History/physical examination with digital rectal examination of the prostate and baseline toxicity assessment within 90 days prior to randomization.
    • Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material;Gleason score must be in the range of 2-6. > 6 cores are strongly recommended.
    • PSA values < 10 ng/ml within 90 days prior to randomization. Either done prior to biopsy or at least 21 days after prostate biopsy.
    • Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.). Staging must be done by treating investigator.
    • No pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
    • Patients must be at least 18 years old.
    • ECOG performance status 0-1 (appendix I) documented within 90 days prior to randomization.
    • IPSS score <= 16.
    • Patients must give IRB approved, study specific, informed consent.
    • Patients must complete all mandatory tests listed in section 4.0 within the specified time frames.
    • Patients must be able to start treatment within 56 days of randomization.

    Exclusion Criteria:

    • Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.
    • Previous pelvic radiation for prostate cancer.
    • Androgen deprivation therapy prior to radiation is allowed. However, it is not acceptable if continued during radiation or as adjuvant therapy.
    • Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis.
    • Prior systemic chemotherapy for prostate cancer.
    • History of proximal urethral stricture requiring dilatation.
    • Current and continuing anticoagulation with warfarin sodium (Coumadin, heparin, low-molecular weight heparin, Clopidogrel bisulfate (Plavix),or equivalent. (Unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or for marker placement).
    • Any major medical, addictive or psychiatric illnesses which would affect the consent process, completion of treatment and/or interfere with follow-up. Consent by legal authorized representative is not permitted in this study.
    • Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed).

    Contact:

    • Tish Adams, MS, CCRC, CP
    • 913-788-6429

    Locations:

    • Mayo Clinic Cancer Center
    • Phoenix Arizona 85054 United States
    • Northwestern Medicine Chicago Proton Center
    • Warrenville Illinois 60555 United States
    • Maryland Proton Treatment Center
    • Baltimore Maryland 21201 United States
    • ProCure Proton Therapy Center
    • Oklahoma City Oklahoma 73142 United States
    • Hampton University Proton Therapy Institute
    • Hampton Virginia 23666 United States

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • A Phase III Randomized Study of Hypofractionated Image-guided Volumetric Modulated Arc Radiotherapy (IG-VMAT) Versus Conventionally Fractionated IG-VMAT in Patients With Localized Prostate Cancer

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    A Phase III Randomized Study of Hypofractionated Image-guided Volumetric Modulated Arc Radiotherapy (IG-VMAT) Versus Conventionally Fractionated IG-VMAT in Patients With Localized Prostate Cancer


    Condition: Prostate Cancer

    Intervention:

    • Radiation: hypofraction
    • Radiation: convention

    Purpose: To determine if hypofractionated IG-VMAT (70 Gy in 28 fractions over 5.6 weeks) will result in disease-free survival (DFS) that is no worse than DFS following conventionally fractionated IG-VMAT (80Gy in 40 fractions over 8 weeks) in patients treated for localized prostate cancer. Analysis the local progression, disease-specific survival (DFS), freedom from biochemical recurrence (FFBR), and overall survival (OS) of two groups. Observe the incidence of GI and GU toxicity.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02934685

    Sponsor: Beijing Hospital

    Primary Outcome Measures:

    • Measure: Biochemical progression free survival
    • Time Frame: up to 18 months
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Incidence of "acute" adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v. 4.0
    • Time Frame: From the start of radiation therapy (RT) to first occurrence of worse severity of adverse event within 30 days after the completion of RT
    • Safety Issue:
    • Measure: Time to "late" grade 2+ adverse events as assessed by NCI CTCAE v. 4.0
    • Time Frame: From the date of completion of RT to the date of first grade 2 or above adverse event occurring 30 days after the completion of RT
    • Safety Issue:
    • Measure: Overall Survival
    • Time Frame: up to 5 years
    • Safety Issue:

    Estimated Enrollment: 60

    Study Start Date: June 2016

    Phase: Phase 3

    Eligibility:

    • Age: minimum 50 Years maximum 79 Years
    • Gender: Male

    Inclusion Criteria:

    • Age 50-79
    • Histologically confirmed prostate adenocarcinoma
    • Clinical stage T1-3N0M0 according to the AJCC 6th edition
    • Gleason score must be >5
    • KPS >70
    • No radical surgery or cryosurgery for prostate cancer

    Exclusion Criteria:

    • Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (For example, carcinoma in situ of the bladder or oral cavity is permissible)
    • Evidence of distant metastases
    • Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
    • Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
    • Previous or concurrent cytotoxic chemotherapy for prostate cancer

    Contact:

    • Qiuzi Zhong
    • +86 13810428903

    Location:

    • Beijing Hospital
    • Beijing China

    View trial on ClinicalTrials.gov


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    Published January 10, 2017
  • A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Sensitive Prostate Cancer

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    A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Sensitive Prostate Cancer


    Condition: Prostate Cancer

    Intervention:

    • Drug: TAK-700
    • Drug: Bicalutamide

    Purpose: The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01809691

    Sponsor: Southwest Oncology Group

    Primary Outcome Measures:

    • Measure: Overall survival
    • Time Frame: 3.2 years
    • Safety Issue:

    Estimated Enrollment: 1304

    Study Start Date: March 2013

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Clinical diagnosis of metastatic prostate cancer.
    • Serum testosterone within institutional limits of normal.
    • PSA ≥ 2 ng/mL within 90 days prior to initiation of androgen deprivation. therapy (for early induction) or prior to registration (for late induction).
    • DEXA scan within 2 years prior to registration.
    • ECG within 42 days prior to registration and QTc interval ≤ 460 msec.
    • LVEF within 42 days prior to registration and within institutional limits of normal.
    • Adequate hepatic function as evidenced by bilirubin ≤ 2 x institutional upper limit of normal (ULN), SGOT (AST) and SGPT (ALT) ≤ 3 x institutional ULN, or ≤ 5 x institutional ULN if liver metastases are present.
    • Adequate renal function as evidenced by calculated creatinine clearance ≥ 40 mL/min.
    • Adequate hematologic function as evidenced by leukocytes ≥ 3,000/mcL, absolute neutrophil count (ANC) ≥ 1,500/mcL, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mcL.
    • Zubrod performance status of 0
    • 2. Zubrod performance status 3 will be allowed if from bone pain only.
    • ≥ 18 years of age.
    • Men of reproduction potential and those who are surgically sterilized (i.e., postvasectomy) must agree to practice effective barrier contraception or agree to abstain from intercourse while receiving treatment on this study and for at least 4 months after protocol treatment ends.

    Exclusion Criteria:

    • Known brain metastases.
    • No more than 36 months of prior neoadjuvant and/or adjuvant hormonal therapy.
    • ≥ 6 months since completion of androgen deprivation therapy.
    • Prior or concurrent therapy with ketoconazole, aminoglutethimide or abiraterone acetate, or enzalutamide (MDV3100). Concurrent megestrol for hot flashes is allowed.
    • Prior chemotherapy for treatment of metastatic prostate cancer. Prior chemotherapy in the neoadjuvant or adjuvant setting is allowed.
    • ≥ 2 years since completion of chemotherapy in the neoadjuvant or adjuvant setting.
    • Concurrent use of experimental therapy is not allowed.
    • ≥ 30 days since prior medical castration for metastatic prostate cancer.
    • If method of castration is a LHRH agonist, the patient must be willing to continue the use of LHRH and add bicalutamide or TAK-700 during protocol treatment.
    • If the patient was on an antiandrogen (e.g. bicalutamide, flutamide), the patient must be willing to switch over to bicalutamide or TAK-700 (according to randomization).
    • Prior bilateral orchiectomy.
    • Concurrent use of LHRH antagonists (e.g. Degarelix)
    • Grade III/IV cardiac disease (as defined by the NYHA Criteria), thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia.
    • Uncontrolled hypertension (defined as blood pressure > 160 mmHg systolic and > 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the Screening visit) despite appropriate medical therapy.
    • Known human immunodeficiency virus (HIV)infection, active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study.
    • History of primary and secondary adrenal insufficiency.
    • Hypersensitivity to TAK-700, to TAK-700 metabolites, to bicalutamide, or to LHRH agonists.
    • Gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of TAK-700, including difficulty swallowing oral medications.
    • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.

    Contact:

    • Nicki Trevino
    • 614-8808 Ext. 1007

    Locations:

    • Veterans Administration Medical Center - Birmingham
    • Birmingham Alabama 35233 United States
    • University of Arizona Cancer Center at Saint Joseph's
    • Phoenix Arizona 85004 United States
    • University of Arizona Cancer Center-Orange Grove Campus
    • Tucson Arizona 85704 United States
    • University of Arizona Cancer Center-North Campus
    • Tucson Arizona 85719 United States
    • Southern Arizona Veterans Affairs Health Center
    • Tucson Arizona 85723 United States
    • The University of Arizona Medical Center-University Campus
    • Tucson Arizona 85724 United States
    • Fowler Family Center for Cancer Care
    • Jonesboro Arkansas 72401 United States
    • Veteran's Administration Medical Center
    • Little Rock Arkansas 72205 United States
    • Kaiser Permanente-Deer Valley Medical Center
    • Antioch California 94531 United States
    • Sutter Auburn Faith Hospital
    • Auburn California 95602 United States
    • AIS Cancer Center at San Joaquin Community Hospital
    • Bakersfield California 93301 United States
    • Alta Bates Summit Medical Center-Herrick Campus
    • Berkeley California 94704 United States
    • Mills - Peninsula Hospitals
    • Burlingame California 94010 United States
    • City of Hope Corona
    • Corona California 92879 United States
    • Sutter Davis Hospital
    • Davis California 95616 United States
    • City of Hope Comprehensive Cancer Center
    • Duarte California 91010 United States
    • Kaiser Permanente-Fremont
    • Fremont California 94538 United States
    • University Oncology Associates
    • Fresno California 93701 United States
    • Kaiser Permanente
    • Fresno California 93720 United States
    • UC San Diego Moores Cancer Center
    • La Jolla California 92093 United States
    • Loma Linda University Medical Center
    • Loma Linda California 92354 United States
    • Veterans Affairs Loma Linda Healthcare System
    • Loma Linda California 92357 United States
    • Los Angeles County-USC Medical Center
    • Los Angeles California 90033 United States
    • USC / Norris Comprehensive Cancer Center
    • Los Angeles California 90033 United States
    • Fremont - Rideout Cancer Center
    • Marysville California 95901 United States
    • Mather Veteran Affairs Medical Center
    • Mather California 95655 United States
    • Mercy UC Davis Cancer Center
    • Merced California 95340 United States
    • Memorial Medical Center
    • Modesto California 95355 United States
    • Kaiser Permanente-Modesto
    • Modesto California 95356 United States
    • Palo Alto Medical Foundation-Camino Division
    • Mountain View California 94040 United States
    • Palo Alto Medical Foundation-Gynecologic Oncology
    • Mountain View California 94040 United States
    • USC Norris Oncology/Hematology-Newport Beach
    • Newport Beach California 92663 United States
    • Sutter Cancer Research Consortium
    • Novato California 94945 United States
    • Kaiser Permanente-Oakland
    • Oakland California 94611 United States
    • UC Irvine Health/Chao Family Comprehensive Cancer Center
    • Orange California 92868 United States
    • Palo Alto Medical Foundation Health Care
    • Palo Alto California 94301 United States
    • Feather River Cancer Center
    • Paradise California 95969 United States
    • Keck Medical Center of USC Pasadena
    • Pasadena California 91105 United States
    • PCR Oncology
    • Pismo Beach California 93449 United States
    • Kaiser Permanente-Redwood City
    • Redwood City California 94063 United States
    • Kaiser Permanente-Richmond
    • Richmond California 94801 United States
    • Kaiser Permanente-Roseville
    • Roseville California 95661 United States
    • Sutter Roseville Medical Center
    • Roseville California 95661 United States
    • Sutter General Hospital
    • Sacramento California 95816 United States
    • University of California Davis Comprehensive Cancer Center
    • Sacramento California 95817 United States
    • Kaiser Permanente-South Sacramento
    • Sacramento California 95823 United States
    • Kaiser Permanente - Sacramento
    • Sacramento California 95825 United States
    • Saint Helena Hospital
    • Saint Helena California 94574 United States
    • California Pacific Medical Center-Pacific Campus
    • San Francisco California 94115 United States
    • Kaiser Permanente-San Francisco
    • San Francisco California 94115 United States
    • UCSF Medical Center-Mount Zion
    • San Francisco California 94115 United States
    • UCSF Medical Center-Mission Bay
    • San Francisco California 94158 United States
    • Kaiser Permanente-Santa Teresa-San Jose
    • San Jose California 95119 United States
    • Kaiser Permanente San Leandro
    • San Leandro California 94577 United States
    • Kaiser Permanente-San Rafael
    • San Rafael California 94903 United States
    • Kaiser Permanente Medical Center - Santa Clara
    • Santa Clara California 95051 United States
    • Palo Alto Medical Foundation-Santa Cruz
    • Santa Cruz California 95065 United States
    • Kaiser Permanente-Santa Rosa
    • Santa Rosa California 95403 United States
    • Sutter Pacific Medical Foundation
    • Santa Rosa California 95403 United States
    • Kaiser Permanente-South San Francisco
    • South San Francisco California 94080 United States
    • Kaiser Permanente-Stockton
    • Stockton California 95210 United States
    • Palo Alto Medical Foundation-Sunnyvale
    • Sunnyvale California 94086 United States
    • Gene Upshaw Memorial Tahoe Forest Cancer Center
    • Truckee California 96161 United States
    • Northbay Cancer Center
    • Vacaville California 95687 United States
    • Kaiser Permanente Medical Center-Vacaville
    • Vacaville California 95688 United States
    • Kaiser Permanente-Vallejo
    • Vallejo California 94589 United States
    • Sutter Solano Medical Center/Cancer Center
    • Vallejo California 94589 United States
    • Kaiser Permanente-Walnut Creek
    • Walnut Creek California 94596 United States
    • Rocky Mountain Cancer Centers-Aurora
    • Aurora Colorado 80012 United States
    • The Medical Center of Aurora
    • Aurora Colorado 80012 United States
    • University of Colorado Cancer Center - Anschutz Cancer Pavilion
    • Aurora Colorado 80045 United States
    • Boulder Community Hospital
    • Boulder Colorado 80301 United States
    • Rocky Mountain Cancer Centers-Boulder
    • Boulder Colorado 80304 United States
    • Penrose-Saint Francis Healthcare
    • Colorado Springs Colorado 80907 United States
    • Rocky Mountain Cancer Centers-Penrose
    • Colorado Springs Colorado 80907 United States
    • Porter Adventist Hospital
    • Denver Colorado 80210 United States
    • Colorado Blood Cancer Institute
    • Denver Colorado 80218 United States
    • Presbyterian - Saint Lukes Medical Center - Health One
    • Denver Colorado 80218 United States
    • Rocky Mountain Cancer Centers-Midtown
    • Denver Colorado 80218 United States
    • SCL Health Saint Joseph Hospital
    • Denver Colorado 80218 United States
    • Rocky Mountain Cancer Centers-Rose
    • Denver Colorado 80220 United States
    • Rose Medical Center
    • Denver Colorado 80220 United States
    • Colorado Cancer Research Program NCORP
    • Denver Colorado 80222 United States
    • Mercy Medical Center
    • Durango Colorado 81301 United States
    • Southwest Oncology PC
    • Durango Colorado 81301 United States
    • Comprehensive Cancer Care and Research Institute of Colorado LLC
    • Englewood Colorado 80113 United States
    • Swedish Medical Center
    • Englewood Colorado 80113 United States
    • Mountain Blue Cancer Care Center
    • Golden Colorado 80401 United States
    • North Colorado Medical Center
    • Greeley Colorado 80631 United States
    • Rocky Mountain Cancer Centers-Greenwood Village
    • Greenwood Village Colorado 80111 United States
    • Rocky Mountain Cancer Centers-Lakewood
    • Lakewood Colorado 80228 United States
    • Saint Anthony Hospital
    • Lakewood Colorado 80228 United States
    • Rocky Mountain Cancer Centers-Littleton
    • Littleton Colorado 80120 United States
    • Littleton Adventist Hospital
    • Littleton Colorado 80122 United States
    • Rocky Mountain Cancer Centers-Sky Ridge
    • Lone Tree Colorado 80124 United States
    • Sky Ridge Medical Center
    • Lone Tree Colorado 80124 United States
    • Longmont United Hospital
    • Longmont Colorado 80501 United States
    • Rocky Mountain Cancer Centers-Longmont
    • Longmont Colorado 80501 United States
    • McKee Medical Center
    • Loveland Colorado 80539 United States
    • Parker Adventist Hospital
    • Parker Colorado 80138 United States
    • Rocky Mountain Cancer Centers-Parker
    • Parker Colorado 80138 United States
    • Saint Mary Corwin Medical Center
    • Pueblo Colorado 81004 United States
    • Rocky Mountain Cancer Centers - Pueblo
    • Pueblo Colorado 81008 United States
    • Rocky Mountain Cancer Centers-Thornton
    • Thornton Colorado 80260 United States
    • SCL Health Lutheran Medical Center
    • Wheat Ridge Colorado 80033 United States
    • Greenwich Hospital
    • Greenwich Connecticut 06830 United States
    • Yale University
    • New Haven Connecticut 06520 United States
    • Eastern Connecticut Hematology and Oncology Associates
    • Norwich Connecticut 06360 United States
    • Stamford Hospital/Bennett Cancer Center
    • Stamford Connecticut 06904 United States
    • Beebe Medical Center
    • Lewes Delaware 19958 United States
    • Medical Oncology Hematology Consultants PA
    • Newark Delaware 19713 United States
    • Regional Hematology and Oncology PA
    • Newark Delaware 19713 United States
    • Christiana Care Health System-Christiana Hospital
    • Newark Delaware 19718 United States
    • Nanticoke Memorial Hospital
    • Seaford Delaware 19973 United States
    • MedStar Georgetown University Hospital
    • Washington, D.C. District of Columbia 20007 United States
    • MedStar Washington Hospital Center
    • Washington, D.C. District of Columbia 20010 United States
    • Sibley Memorial Hospital
    • Washington, D.C. District of Columbia 20016 United States
    • George Washington University Medical Center
    • Washington, D.C. District of Columbia 20037 United States
    • Veterans Affairs Medical Center -Washington DC
    • Washington, D.C. District of Columbia 20422 United States
    • Broward Health Medical Center
    • Fort Lauderdale Florida 33316 United States
    • Lakeland Regional Health Hollis Cancer Center
    • Lakeland Florida 33805 United States
    • Florida Hospital Orlando
    • Orlando Florida 32803 United States
    • UF Cancer Center at Orlando Health
    • Orlando Florida 32806 United States
    • Moffitt Cancer Center
    • Tampa Florida 33612 United States
    • John B Amos Cancer Center
    • Columbus Georgia 31904 United States
    • Atlanta VA Medical Center
    • Decatur Georgia 30033 United States
    • Northeast Georgia Medical Center-Gainesville
    • Gainesville Georgia 30501 United States
    • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    • Savannah Georgia 31405 United States
    • Hawaii Oncology Inc-Pali Momi
    • 'Aiea Hawaii 96701 United States
    • Hawaii Cancer Care Inc-POB II
    • Honolulu Hawaii 96813 United States
    • Queen's Medical Center
    • Honolulu Hawaii 96813 United States
    • University of Hawaii Cancer Center
    • Honolulu Hawaii 96813 United States
    • Hawaii Cancer Care Inc-Liliha
    • Honolulu Hawaii 96817 United States
    • Hawaii Oncology Inc-Kuakini
    • Honolulu Hawaii 96817 United States
    • Kaiser Permanente Moanalua Medical Center
    • Honolulu Hawaii 96819 United States
    • Tripler Army Medical Center
    • Honolulu Hawaii 96859 United States
    • Saint Alphonsus Cancer Care Center-Boise
    • Boise Idaho 83706 United States
    • Kootenai Medical Center
    • Coeur d'Alene Idaho 83814 United States
    • Kootenai Cancer Center
    • Post Falls Idaho 83854 United States
    • Kootenai Cancer Clinic
    • Sandpoint Idaho 83864 United States
    • Rush - Copley Medical Center
    • Aurora Illinois 60504 United States
    • Saint Joseph Medical Center
    • Bloomington Illinois 61701 United States
    • Illinois CancerCare-Bloomington
    • Bloomington Illinois 61704 United States
    • Illinois CancerCare-Canton
    • Canton Illinois 61520 United States
    • Illinois CancerCare-Carthage
    • Carthage Illinois 62321 United States
    • Centralia Oncology Clinic
    • Centralia Illinois 62801 United States
    • Mount Sinai Hospital Medical Center
    • Chicago Illinois 60608 United States
    • Northwestern University
    • Chicago Illinois 60611 United States
    • University of Illinois
    • Chicago Illinois 60612 United States
    • University of Chicago Comprehensive Cancer Center
    • Chicago Illinois 60637 United States
    • Weiss Memorial Hospital
    • Chicago Illinois 60640 United States
    • Presence Saint Joseph Hospital-Chicago
    • Chicago Illinois 60657 United States
    • Cancer Care Center of Decatur
    • Decatur Illinois 62526 United States
    • Decatur Memorial Hospital
    • Decatur Illinois 62526 United States
    • Heartland Cancer Research NCORP
    • Decatur Illinois 62526 United States
    • Crossroads Cancer Center
    • Effingham Illinois 62401 United States
    • Illinois CancerCare-Eureka
    • Eureka Illinois 61530 United States
    • NorthShore University HealthSystem-Evanston Hospital
    • Evanston Illinois 60201 United States
    • Illinois CancerCare-Galesburg
    • Galesburg Illinois 61401 United States
    • Northwestern Medicine Cancer Center Delnor
    • Geneva Illinois 60134 United States
    • NorthShore University HealthSystem-Glenbrook Hospital
    • Glenview Illinois 60026 United States
    • NorthShore University HealthSystem-Highland Park Hospital
    • Highland Park Illinois 60035 United States
    • Hines Veterans Administration Hospital
    • Hines Illinois 60141 United States
    • Joliet Oncology-Hematology Associates Limited
    • Joliet Illinois 60435 United States
    • Presence Saint Mary's Hospital
    • Kankakee Illinois 60901 United States
    • Illinois CancerCare-Kewanee Clinic
    • Kewanee Illinois 61443 United States
    • Illinois CancerCare-Macomb
    • Macomb Illinois 61455 United States
    • Loyola University Medical Center
    • Maywood Illinois 60153 United States
    • Trinity Medical Center
    • Moline Illinois 61265 United States
    • Illinois CancerCare-Monmouth
    • Monmouth Illinois 61462 United States
    • Community Cancer Center Foundation
    • Normal Illinois 61761 United States
    • Illinois CancerCare-Ottawa Clinic
    • Ottawa Illinois 61350 United States
    • Ottawa Regional Hospital and Healthcare Center
    • Ottawa Illinois 61350 United States
    • Illinois CancerCare-Pekin
    • Pekin Illinois 61554 United States
    • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
    • Pekin Illinois 61554 United States
    • Methodist Medical Center of Illinois
    • Peoria Illinois 61603 United States
    • Proctor Hospital
    • Peoria Illinois 61614 United States
    • Illinois CancerCare-Peoria
    • Peoria Illinois 61615 United States
    • OSF Saint Francis Medical Center
    • Peoria Illinois 61637 United States
    • Illinois CancerCare-Peru
    • Peru Illinois 61354 United States
    • Illinois CancerCare-Princeton
    • Princeton Illinois 61356 United States
    • West Suburban Medical Center
    • River Forest Illinois 60305 United States
    • SwedishAmerican Regional Cancer Center/ACT
    • Rockford Illinois 61114 United States
    • Southern Illinois University School of Medicine
    • Springfield Illinois 62702 United States
    • Springfield Clinic
    • Springfield Illinois 62702 United States
    • Memorial Medical Center
    • Springfield Illinois 62781 United States
    • Cancer Care Specialists of Illinois-Swansea
    • Swansea Illinois 62226 United States
    • Carle Cancer Center
    • Urbana Illinois 61801 United States
    • Northwestern Medicine Cancer Center Warrenville
    • Warrenville Illinois 60555 United States
    • Rush-Copley Healthcare Center
    • Yorkville Illinois 60560 United States
    • IU Health Bloomington
    • Bloomington Indiana 47403 United States
    • Memorial Regional Cancer Center Day Road
    • Mishawaka Indiana 46545 United States
    • Memorial Hospital of South Bend
    • South Bend Indiana 46601 United States
    • Porter Memorial Hospital
    • Valparaiso Indiana 46383 United States
    • McFarland Clinic PC-William R Bliss Cancer Center
    • Ames Iowa 50010 United States
    • Mercy Hospital
    • Cedar Rapids Iowa 52403 United States
    • Oncology Associates at Mercy Medical Center
    • Cedar Rapids Iowa 52403 United States
    • Medical Oncology and Hematology Associates-West Des Moines
    • Clive Iowa 50325 United States
    • Alegent Health Mercy Hospital
    • Council Bluffs Iowa 51503 United States
    • Genesis Medical Center - East Campus
    • Davenport Iowa 52803 United States
    • Medical Oncology and Hematology Associates-Laurel
    • Des Moines Iowa 50314 United States
    • Mercy Medical Center - Des Moines
    • Des Moines Iowa 50314 United States
    • University of Iowa/Holden Comprehensive Cancer Center
    • Iowa City Iowa 52242 United States
    • Iowa City VA Healthcare System
    • Iowa City Iowa 52246 United States
    • Cancer Center of Kansas - Chanute
    • Chanute Kansas 66720 United States
    • Cancer Center of Kansas - Dodge City
    • Dodge City Kansas 67801 United States
    • Cancer Center of Kansas - El Dorado
    • El Dorado Kansas 67042 United States
    • Cancer Center of Kansas - Fort Scott
    • Fort Scott Kansas 66701 United States
    • Saint Catherine Hospital
    • Garden City Kansas 67846 United States
    • Heartland Cancer Center
    • Great Bend Kansas 67530 United States
    • Saint Rose Ambulatory and Surgery Center
    • Great Bend Kansas 67530 United States
    • Hays Medical Center
    • Hays Kansas 67601 United States
    • Cancer Center of Kansas-Independence
    • Independence Kansas 67301 United States
    • University of Kansas Cancer Center-West
    • Kansas City Kansas 66112 United States
    • University of Kansas Cancer Center
    • Kansas City Kansas 66160 United States
    • Cancer Center of Kansas-Kingman
    • Kingman Kansas 67068 United States
    • Lawrence Memorial Hospital
    • Lawrence Kansas 66044 United States
    • Cancer Center of Kansas-Liberal
    • Liberal Kansas 67905 United States
    • Cancer Center of Kansas-Manhattan
    • Manhattan Kansas 66502 United States
    • Cancer Center of Kansas - McPherson
    • McPherson Kansas 67460 United States
    • Cancer Center of Kansas - Newton
    • Newton Kansas 67114 United States
    • Olathe Medical Center
    • Olathe Kansas 66061 United States
    • Menorah Medical Center
    • Overland Park Kansas 66209 United States
    • University of Kansas Cancer Center-Overland Park
    • Overland Park Kansas 66210 United States
    • Cancer Center of Kansas - Parsons
    • Parsons Kansas 67357 United States
    • Cancer Center of Kansas - Pratt
    • Pratt Kansas 67124 United States
    • Cancer Center of Kansas - Salina
    • Salina Kansas 67401 United States
    • Salina Regional Health Center
    • Salina Kansas 67401 United States
    • Cotton O'Neil Cancer Center / Stormont Vail Health
    • Topeka Kansas 66606 United States
    • Saint Francis Hospital and Medical Center - Topeka
    • Topeka Kansas 66606 United States
    • Topeka VA Hospital
    • Topeka Kansas 66622 United States
    • Cancer Center of Kansas - Wellington
    • Wellington Kansas 67152 United States
    • Associates In Womens Health
    • Wichita Kansas 67208 United States
    • Cancer Center of Kansas-Wichita Medical Arts Tower
    • Wichita Kansas 67208 United States
    • Cancer Center of Kansas - Wichita
    • Wichita Kansas 67214 United States
    • Via Christi Regional Medical Center
    • Wichita Kansas 67214 United States
    • Wichita NCI Community Oncology Research Program
    • Wichita Kansas 67214 United States
    • Cancer Center of Kansas - Winfield
    • Winfield Kansas 67156 United States
    • University of Kentucky/Markey Cancer Center
    • Lexington Kentucky 40536 United States
    • Hematology/Oncology Clinic LLP
    • Baton Rouge Louisiana 70809 United States
    • Ochsner Health Center-Summa
    • Baton Rouge Louisiana 70809 United States
    • Ochsner Medical Center Kenner
    • Kenner Louisiana 70065 United States
    • East Jefferson General Hospital
    • Metairie Louisiana 70006 United States
    • Louisiana State University Health Science Center
    • New Orleans Louisiana 70112 United States
    • Tulane University Health Sciences Center
    • New Orleans Louisiana 70112 United States
    • University Medical Center New Orleans
    • New Orleans Louisiana 70112 United States
    • Ochsner Medical Center Jefferson
    • New Orleans Louisiana 70121 United States
    • Louisiana State University Health Sciences Center Shreveport
    • Shreveport Louisiana 71103 United States
    • Harold Alfond Center for Cancer Care
    • Augusta Maine 04330 United States
    • Eastern Maine Medical Center
    • Bangor Maine 04401 United States
    • Penobscot Bay Medical Center
    • Rockport Maine 04856 United States
    • Johns Hopkins University/Sidney Kimmel Cancer Center
    • Baltimore Maryland 21287 United States
    • Montgomery General Hospital-Olney
    • Olney Maryland 20832 United States
    • Boston Medical Center
    • Boston Massachusetts 02118 United States
    • Dana-Farber Cancer Institute
    • Boston Massachusetts 02215 United States
    • Steward Saint Elizabeth's Medical Center
    • Brighton Massachusetts 02135 United States
    • Lahey Hospital and Medical Center
    • Burlington Massachusetts 01805 United States
    • Saint Anne's Hospital
    • Fall River Massachusetts 02721 United States
    • Dana Farber Community Cancer Care-Quincy
    • Quincy Massachusetts 02169 United States
    • Baystate Medical Center
    • Springfield Massachusetts 01199 United States
    • Hickman Cancer Center
    • Adrian Michigan 49221 United States
    • Saint Joseph Mercy Hospital
    • Ann Arbor Michigan 48106-0995 United States
    • Michigan Cancer Research Consortium NCORP
    • Ann Arbor Michigan 48106 United States
    • University of Michigan Comprehensive Cancer Center
    • Ann Arbor Michigan 48109 United States
    • Bronson Battle Creek
    • Battle Creek Michigan 49017 United States
    • IHA Hematology Oncology Consultants-Brighton
    • Brighton Michigan 48114 United States
    • Saint Joseph Mercy Brighton
    • Brighton Michigan 48114 United States
    • IHA Hematology Oncology Consultants-Canton
    • Canton Michigan 48188 United States
    • Saint Joseph Mercy Canton Health Center
    • Canton Michigan 48188 United States
    • IHA Hematology Oncology Consultants-Chelsea
    • Chelsea Michigan 48118 United States
    • Saint Joseph Mercy Chelsea
    • Chelsea Michigan 48118 United States
    • Saint John Hospital and Medical Center
    • Detroit Michigan 48236 United States
    • Green Bay Oncology - Escanaba
    • Escanaba Michigan 49829 United States
    • Botsford General Hospital
    • Farmington Michigan 48334 United States
    • Cancer Research Consortium of West Michigan NCORP
    • Grand Rapids Michigan 49503 United States
    • Mercy Health Saint Mary's
    • Grand Rapids Michigan 49503 United States
    • Spectrum Health at Butterworth Campus
    • Grand Rapids Michigan 49503 United States
    • Green Bay Oncology - Iron Mountain
    • Iron Mountain Michigan 49801 United States
    • West Michigan Cancer Center
    • Kalamazoo Michigan 49007 United States
    • Sparrow Hospital
    • Lansing Michigan 48912 United States
    • Mercy Health Mercy Campus
    • Muskegon Michigan 49444 United States
    • Lakeland Community Hospital
    • Niles Michigan 49120 United States
    • Saint Joseph Mercy Oakland
    • Pontiac Michigan 48341 United States
    • Lake Huron Medical Center
    • Port Huron Michigan 48060 United States
    • Spectrum Health Reed City Hospital
    • Reed City Michigan 49677 United States
    • William Beaumont Hospital-Royal Oak
    • Royal Oak Michigan 48073 United States
    • Saint Mary's of Michigan
    • Saginaw Michigan 48601 United States
    • Marie Yeager Cancer Center
    • Saint Joseph Michigan 49085 United States
    • Munson Medical Center
    • Traverse City Michigan 49684 United States
    • William Beaumont Hospital - Troy
    • Troy Michigan 48098 United States
    • Saint John Macomb-Oakland Hospital
    • Warren Michigan 48093 United States
    • IHA Hematology Oncology Consultants-Ann Arbor
    • Ypsilanti Michigan 48197 United States
    • Sanford Clinic North-Bemidgi
    • Bemidji Minnesota 56601 United States
    • Fairview Ridges Hospital
    • Burnsville Minnesota 55337 United States
    • Mercy Hospital
    • Coon Rapids Minnesota 55433 United States
    • Essentia Health Cancer Center
    • Duluth Minnesota 55805 United States
    • Fairview-Southdale Hospital
    • Edina Minnesota 55435 United States
    • Lake Region Healthcare Corporation-Cancer Care
    • Fergus Falls Minnesota 56537 United States
    • Unity Hospital
    • Fridley Minnesota 55432 United States
    • Minnesota Oncology Hematology PA-Maplewood
    • Maplewood Minnesota 55109 United States
    • Saint John's Hospital - Healtheast
    • Maplewood Minnesota 55109 United States
    • Abbott-Northwestern Hospital
    • Minneapolis Minnesota 55407 United States
    • Hennepin County Medical Center
    • Minneapolis Minnesota 55415 United States
    • Minneapolis Veterans Medical Center
    • Minneapolis Minnesota 55417 United States
    • Health Partners Inc
    • Minneapolis Minnesota 55454 United States
    • University of Minnesota/Masonic Cancer Center
    • Minneapolis Minnesota 55455 United States
    • North Memorial Medical Health Center
    • Robbinsdale Minnesota 55422 United States
    • Mayo Clinic
    • Rochester Minnesota 55905 United States
    • Coborn Cancer Center at Saint Cloud Hospital
    • Saint Cloud Minnesota 56303 United States
    • Metro Minnesota Community Oncology Research Consortium
    • Saint Louis Park Minnesota 55416 United States
    • Park Nicollet Clinic - Saint Louis Park
    • Saint Louis Park Minnesota 55416 United States
    • Regions Hospital
    • Saint Paul Minnesota 55101 United States
    • United Hospital
    • Saint Paul Minnesota 55102 United States
    • Saint Francis Regional Medical Center
    • Shakopee Minnesota 55379 United States
    • Lakeview Hospital
    • Stillwater Minnesota 55082 United States
    • Ridgeview Medical Center
    • Waconia Minnesota 55387 United States
    • Rice Memorial Hospital
    • Willmar Minnesota 56201 United States
    • Minnesota Oncology Hematology PA-Woodbury
    • Woodbury Minnesota 55125 United States
    • University of Mississippi Medical Center
    • Jackson Mississippi 39216 United States
    • Saint Francis Medical Center
    • Cape Girardeau Missouri 63703 United States
    • Southeast Cancer Center
    • Cape Girardeau Missouri 63703 United States
    • University of Missouri - Ellis Fischel
    • Columbia Missouri 65212 United States
    • Barnes-Jewish West County Hospital
    • Creve Coeur Missouri 63141 United States
    • Mercy Hospital-Joplin
    • Joplin Missouri 64804 United States
    • Truman Medical Center
    • Kansas City Missouri 64108 United States
    • Saint Luke's Hospital of Kansas City
    • Kansas City Missouri 64111 United States
    • Kansas City Veterans Affairs Medical Center
    • Kansas City Missouri 64128 United States
    • The University of Kansas Cancer Center-South
    • Kansas City Missouri 64131 United States
    • Research Medical Center
    • Kansas City Missouri 64132 United States
    • The University of Kansas Cancer Center-North
    • Kansas City Missouri 64154 United States
    • The University of Kansas Cancer Center-Lee's Summit
    • Lee's Summit Missouri 64064 United States
    • Delbert Day Cancer Institute at PCRMC
    • Rolla Missouri 65401 United States
    • Heartland Regional Medical Center
    • Saint Joseph Missouri 64506 United States
    • Saint Louis Cancer and Breast Institute-South City
    • Saint Louis Missouri 63109 United States
    • Washington University School of Medicine
    • Saint Louis Missouri 63110 United States
    • Missouri Baptist Medical Center
    • Saint Louis Missouri 63131 United States
    • Mercy Hospital Saint Louis
    • Saint Louis Missouri 63141 United States
    • Siteman Cancer Center - Saint Peters
    • Saint Peters Missouri 63376 United States
    • Mercy Hospital Springfield
    • Springfield Missouri 65804 United States
    • CoxHealth South Hospital
    • Springfield Missouri 65807 United States
    • Billings Clinic Cancer Center
    • Billings Montana 59101 United States
    • Saint Vincent Healthcare
    • Billings Montana 59101 United States
    • Montana Cancer Consortium NCORP
    • Billings Montana 59102 United States
    • Bozeman Deaconess Hospital
    • Bozeman Montana 59715 United States
    • Benefis Healthcare- Sletten Cancer Institute
    • Great Falls Montana 59405 United States
    • CHI Health Saint Francis
    • Grand Island Nebraska 68803 United States
    • CHI Health Good Samaritan
    • Kearney Nebraska 68847 United States
    • Nebraska Methodist Hospital
    • Omaha Nebraska 68114 United States
    • Alegent Health Immanuel Medical Center
    • Omaha Nebraska 68122 United States
    • Alegent Health Bergan Mercy Medical Center
    • Omaha Nebraska 68124 United States
    • Alegent Health Lakeside Hospital
    • Omaha Nebraska 68130 United States
    • Creighton University Medical Center
    • Omaha Nebraska 68131 United States
    • Nevada Cancer Research Foundation CCOP
    • Las Vegas Nevada 89106 United States
    • Comprehensive Cancer Centers of Nevada
    • Las Vegas Nevada 89148 United States
    • Comprehensive Cancer Centers of Nevada - Central Valley
    • Las Vegas Nevada 89169 United States
    • Renown Regional Medical Center
    • Reno Nevada 89502 United States
    • New Hampshire Oncology Hematology PA-Concord
    • Concord New Hampshire 03301 United States
    • New Hampshire Oncology Hematology PA-Hooksett
    • Hooksett New Hampshire 03106 United States
    • LRGHealthcare-Lakes Region General Hospital
    • Laconia New Hampshire 03246 United States
    • Veterans Adminstration New Jersey Health Care System
    • East Orange New Jersey 07018-1095 United States
    • Rutgers Cancer Institute of New Jersey
    • New Brunswick New Jersey 08903 United States
    • Sparta Cancer Treatment Center
    • Sparta New Jersey 07871 United States
    • Lovelace Medical Center-Downtown
    • Albuquerque New Mexico 87102 United States
    • University of New Mexico Cancer Center
    • Albuquerque New Mexico 87102 United States
    • Hematology Oncology Associates
    • Albuquerque New Mexico 87106 United States
    • Memorial Medical Center - Las Cruces
    • Las Cruces New Mexico 88011 United States
    • Christus Saint Vincent Regional Cancer Center
    • Santa Fe New Mexico 87505 United States
    • Veteran Affairs New York Harbor Healthcare System-Brooklyn Campus
    • Brooklyn New York 11209 United States
    • Veterans Affairs Western New York Health Care System-Buffalo
    • Buffalo New York 14215 United States
    • Roswell Park Cancer Institute
    • Buffalo New York 14263 United States
    • Hematology Oncology Associates of Central New York-East Syracuse
    • East Syracuse New York 13057 United States
    • Arnot Ogden Medical Center/Falck Cancer Center
    • Elmira New York 14905 United States
    • Glens Falls Hospital
    • Glens Falls New York 12801 United States
    • Orange Regional Medical Center
    • Middletown New York 10940 United States
    • Laura and Isaac Perlmutter Cancer Center at NYU Langone
    • New York New York 10016 United States
    • Columbia University/Herbert Irving Cancer Center
    • New York New York 10032 United States
    • Weill Medical College of Cornell University
    • New York New York 10065 United States
    • University of Rochester
    • Rochester New York 14642 United States
    • State University of New York Upstate Medical University
    • Syracuse New York 13210 United States
    • Montefiore Medical Center-Weiler Hospital
    • The Bronx New York 10461 United States
    • Montefiore Medical Center - Moses Campus
    • The Bronx New York 10467-2490 United States
    • Dickstein Cancer Treatment Center
    • White Plains New York 10601 United States
    • Mission Hospital-Memorial Campus
    • Asheville North Carolina 28801 United States
    • Carolinas Medical Center/Levine Cancer Institute
    • Charlotte North Carolina 28203 United States
    • Carolinas HealthCare System NorthEast
    • Concord North Carolina 28025 United States
    • Hendersonville Hematology and Oncology at Pardee
    • Hendersonville North Carolina 28791 United States
    • Margaret R Pardee Memorial Hospital
    • Hendersonville North Carolina 28791 United States
    • Park Ridge Hospital Breast Health Center
    • Hendersonville North Carolina 28792 United States
    • Kinston Medical Specialists PA
    • Kinston North Carolina 28501 United States
    • Carolinas HealthCare System Union
    • Monroe North Carolina 28112 United States
    • Carolinas HealthCare System Cleveland
    • Shelby North Carolina 28150 United States
    • Iredell Memorial Hospital
    • Statesville North Carolina 28677 United States
    • Southeast Clinical Oncology Research (SCOR) Consortium NCORP
    • Winston-Salem North Carolina 27104 United States
    • Sanford Bismarck Medical Center
    • Bismarck North Dakota 58501 United States
    • Roger Maris Cancer Center
    • Fargo North Dakota 58122 United States
    • Sanford Clinic North-Fargo
    • Fargo North Dakota 58122 United States
    • Sanford Medical Center-Fargo
    • Fargo North Dakota 58122 United States
    • Summa Akron City Hospital/Cooper Cancer Center
    • Akron Ohio 44304 United States
    • Summa Barberton Hospital
    • Barberton Ohio 44203 United States
    • Adena Regional Medical Center
    • Chillicothe Ohio 45601 United States
    • The Christ Hospital
    • Cincinnati Ohio 45219 United States
    • University of Cincinnati/Barrett Cancer Center
    • Cincinnati Ohio 45219 United States
    • MetroHealth Medical Center
    • Cleveland Ohio 44109 United States
    • Ohio State University Comprehensive Cancer Center
    • Columbus Ohio 43210 United States
    • Columbus Oncology and Hematology Associates Inc
    • Columbus Ohio 43214 United States
    • Riverside Methodist Hospital
    • Columbus Ohio 43214 United States
    • Columbus NCI Community Oncology Research Program
    • Columbus Ohio 43215 United States
    • Grant Medical Center
    • Columbus Ohio 43215 United States
    • The Mark H Zangmeister Center
    • Columbus Ohio 43219 United States
    • Mount Carmel Health Center West
    • Columbus Ohio 43222 United States
    • Good Samaritan Hospital - Dayton
    • Dayton Ohio 45406 United States
    • Miami Valley Hospital
    • Dayton Ohio 45409 United States
    • Samaritan North Health Center
    • Dayton Ohio 45415 United States
    • Dayton NCI Community Oncology Research Program
    • Dayton Ohio 45420 United States
    • Veteran Affairs Medical Center
    • Dayton Ohio 45428 United States
    • Delaware Health Center-Grady Cancer Center
    • Delaware Ohio 43015 United States
    • Armes Family Cancer Center
    • Findlay Ohio 45840 United States
    • Orion Cancer Care
    • Findlay Ohio 45840 United States
    • Atrium Medical Center-Middletown Regional Hospital
    • Franklin Ohio 45005-1066 United States
    • Dayton Physicians LLC-Atrium
    • Franklin Ohio 45005 United States
    • Kettering Medical Center
    • Kettering Ohio 45429 United States
    • Saint Rita's Medical Center
    • Lima Ohio 45801 United States
    • Marietta Memorial Hospital
    • Marietta Ohio 45750 United States
    • Toledo Clinic Cancer Centers-Maumee
    • Maumee Ohio 43537 United States
    • Saint Charles Hospital
    • Oregon Ohio 43616 United States
    • Mercy Health Perrysburg Cancer Center
    • Perrysburg Ohio 43551 United States
    • Southern Ohio Medical Center
    • Portsmouth Ohio 45662 United States
    • Springfield Regional Medical Center
    • Springfield Ohio 45505 United States
    • Mercy Saint Anne Hospital
    • Toledo Ohio 43623 United States
    • Toledo Clinic Cancer Centers-Toledo
    • Toledo Ohio 43623 United States
    • Upper Valley Medical Center
    • Troy Ohio 45373 United States
    • Saint Ann's Hospital
    • Westerville Ohio 43081 United States
    • Wright-Patterson Medical Center
    • Wright-Patterson Air Force Base Ohio 45433-5529 United States
    • University of Oklahoma Health Sciences Center
    • Oklahoma City Oklahoma 73104 United States
    • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Tulsa Oklahoma 74146 United States
    • Legacy Mount Hood Medical Center
    • Gresham Oregon 97030 United States
    • Legacy Good Samaritan Hospital and Medical Center
    • Portland Oregon 97210 United States
    • Kaiser Permanente Northwest
    • Portland Oregon 97227 United States
    • Oregon Health and Science University
    • Portland Oregon 97239 United States
    • Portland Veterans Administration Medical Center
    • Portland Oregon 97239 United States
    • Legacy Meridian Park Hospital
    • Tualatin Oregon 97062 United States
    • Lehigh Valley Hospital-Cedar Crest
    • Allentown Pennsylvania 18103 United States
    • Lehigh Valley Hospital - Muhlenberg
    • Bethlehem Pennsylvania 18017 United States
    • Doylestown Hospital
    • Doylestown Pennsylvania 18901 United States
    • Penn State Milton S Hershey Medical Center
    • Hershey Pennsylvania 17033-0850 United States
    • Thomas Jefferson University Hospital
    • Philadelphia Pennsylvania 19107 United States
    • Fox Chase Cancer Center
    • Philadelphia Pennsylvania 19111 United States
    • Temple University Hospital
    • Philadelphia Pennsylvania 19140 United States
    • Hematology and Oncology Associates of North East Pennsylvania
    • Scranton Pennsylvania 18508 United States
    • Reading Hospital
    • West Reading Pennsylvania 19611 United States
    • Susquehanna Cancer Center
    • Williamsport Pennsylvania 17701 United States
    • AnMed Health Cancer Center
    • Anderson South Carolina 29621 United States
    • Roper Hospital
    • Charleston South Carolina 29401 United States
    • Charleston Hematology Oncology Associates-Roper
    • Charleston South Carolina 29403 United States
    • Charleston Hematology Oncology Associates PA-St. Francis
    • Charleston South Carolina 29414 United States
    • Medical University of South Carolina
    • Charleston South Carolina 29425 United States
    • Greenville Health System Cancer Institute-Easley
    • Easley South Carolina 29640 United States
    • McLeod Regional Medical Center
    • Florence South Carolina 29506 United States
    • Saint Francis Hospital
    • Greenville South Carolina 29601 United States
    • Greenville Health System Cancer Institute-Butternut
    • Greenville South Carolina 29605 United States
    • Greenville Health System Cancer Institute-Faris
    • Greenville South Carolina 29605 United States
    • Greenville Memorial Hospital
    • Greenville South Carolina 29605 United States
    • Saint Francis Cancer Center
    • Greenville South Carolina 29607 United States
    • Greenville Health System Cancer Institute-Eastside
    • Greenville South Carolina 29615 United States
    • Self Regional Healthcare
    • Greenwood South Carolina 29646 United States
    • Greenville Health System Cancer Institute-Greer
    • Greer South Carolina 29650 United States
    • Greenville Health System Cancer Institute-Seneca
    • Seneca South Carolina 29672 United States
    • Spartanburg Medical Center
    • Spartanburg South Carolina 29303 United States
    • Greenville Health System Cancer Institute-Spartanburg
    • Spartanburg South Carolina 29307 United States
    • Sanford Cancer Center-Oncology Clinic
    • Sioux Falls South Dakota 57104 United States
    • Sanford USD Medical Center - Sioux Falls
    • Sioux Falls South Dakota 57117-5134 United States
    • Erlanger Medical Center
    • Chattanooga Tennessee 37403 United States
    • University of Tennessee - Knoxville
    • Knoxville Tennessee 37920 United States
    • Meharry Medical College
    • Nashville Tennessee 37208 United States
    • UT Southwestern/Simmons Cancer Center-Dallas
    • Dallas Texas 75390 United States
    • Lyndon Baines Johnson General Hospital
    • Houston Texas 77026-1967 United States
    • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
    • Houston Texas 77030 United States
    • Ben Taub General Hospital
    • Houston Texas 77030 United States
    • M D Anderson Cancer Center
    • Houston Texas 77030 United States
    • Michael E DeBakey VA Medical Center
    • Houston Texas 77030 United States
    • MD Anderson Regional Care Center-Katy
    • Houston Texas 77094 United States
    • MD Anderson Regional Care Center-Bay Area
    • Nassau Bay Texas 77058 United States
    • MD Anderson Regional Care Center-Sugar Land
    • Sugar Land Texas 77478 United States
    • MD Anderson Regional Care Center-The Woodlands
    • The Woodlands Texas 77384 United States
    • Huntsman Cancer Institute/University of Utah
    • Salt Lake City Utah 84112 United States
    • Inova Fairfax Hospital
    • Falls Church Virginia 22042 United States
    • Lynchburg Hematology-Oncology Clinic
    • Lynchburg Virginia 24501 United States
    • Memorial Hospital Of Martinsville
    • Martinsville Virginia 24115 United States
    • Virginia Commonwealth University/Massey Cancer Center
    • Richmond Virginia 23298 United States
    • VCU Community Memorial Health Center
    • South Hill Virginia 23970 United States
    • Shenandoah Oncology Associates PC
    • Winchester Virginia 22601 United States
    • MultiCare Auburn Medical Center
    • Auburn Washington 98001 United States
    • PeaceHealth Saint Joseph Medical Center
    • Bellingham Washington 98225 United States
    • Highline Medical Center-Main Campus
    • Burien Washington 98166 United States
    • Providence Regional Cancer Partnership
    • Everett Washington 98201 United States
    • MultiCare Gig Harbor Medical Park
    • Gig Harbor Washington 98335 United States
    • Kadlec Clinic Hematology and Oncology
    • Kennewick Washington 99336 United States
    • Seattle Cancer Care Alliance at EvergreenHealth
    • Kirkland Washington 98034 United States
    • Skagit Valley Hospital
    • Mount Vernon Washington 98274 United States
    • Jefferson Healthcare
    • Port Townsend Washington 98368 United States
    • MultiCare Good Samaritan Hospital
    • Puyallup Washington 98372 United States
    • Minor and James Medical PLLC
    • Seattle Washington 98104 United States
    • Fred Hutchinson Cancer Research Center
    • Seattle Washington 98109 United States
    • Group Health Cooperative-Seattle
    • Seattle Washington 98112 United States
    • Swedish Medical Center-First Hill
    • Seattle Washington 98122-4307 United States
    • University of Washington Medical Center
    • Seattle Washington 98195 United States
    • Rockwood Clinic Cancer Treatment Center-Valley
    • Spokane Valley Washington 99216 United States
    • Rockwood Cancer Treatment Center-DHEC-Downtown
    • Spokane Washington 99204 United States
    • Rockwood Clinic
    • Spokane Washington 99220 United States
    • MultiCare Tacoma General Hospital
    • Tacoma Washington 98405 United States
    • Northwest NCI Community Oncology Research Program
    • Tacoma Washington 98405 United States
    • Madigan Army Medical Center
    • Tacoma Washington 98431 United States
    • Legacy Salmon Creek Hospital
    • Vancouver Washington 98686 United States
    • Providence Saint Mary Regional Cancer Center
    • Walla Walla Washington 99362 United States
    • West Virginia University Charleston
    • Charleston West Virginia 25304 United States
    • Edwards Comprehensive Cancer Center
    • Huntington West Virginia 25701 United States
    • Langlade Hospital and Cancer Center
    • Antigo Wisconsin 54409 United States
    • Aurora Cancer Care-Southern Lakes VLCC
    • Burlington Wisconsin 53105 United States
    • Marshfield Clinic-Chippewa Center
    • Chippewa Falls Wisconsin 54729 United States
    • Marshfield Clinic Cancer Center at Sacred Heart
    • Eau Claire Wisconsin 54701 United States
    • Sacred Heart Hospital
    • Eau Claire Wisconsin 54701 United States
    • Aurora Health Center-Fond du Lac
    • Fond du Lac Wisconsin 54937 United States
    • Aurora Health Care Germantown Health Center
    • Germantown Wisconsin 53022 United States
    • Aurora Cancer Care-Grafton
    • Grafton Wisconsin 53024 United States
    • Green Bay Oncology at Saint Vincent Hospital
    • Green Bay Wisconsin 54301-3526 United States
    • Saint Vincent Hospital Cancer Center Green Bay
    • Green Bay Wisconsin 54301 United States
    • Green Bay Oncology Limited at Saint Mary's Hospital
    • Green Bay Wisconsin 54303 United States
    • Saint Vincent Hospital Cancer Center at Saint Mary's
    • Green Bay Wisconsin 54303 United States
    • Aurora BayCare Medical Center
    • Green Bay Wisconsin 54311 United States
    • Mercy Health System
    • Janesville Wisconsin 53547 United States
    • UW Cancer Center Johnson Creek
    • Johnson Creek Wisconsin 53038 United States
    • Aurora Cancer Care-Kenosha South
    • Kenosha Wisconsin 53142 United States
    • Gundersen Lutheran Medical Center
    • La Crosse Wisconsin 54601 United States
    • Marshfield Clinic - Ladysmith Center
    • Ladysmith Wisconsin 54848 United States
    • University of Wisconsin Hospital and Clinics
    • Madison Wisconsin 53792 United States
    • Holy Family Memorial Hospital
    • Manitowoc Wisconsin 54221 United States
    • Aurora Bay Area Medical Group-Marinette
    • Marinette Wisconsin 54143 United States
    • Vince Lombardi Cancer Clinic-Marinette
    • Marinette Wisconsin 54143 United States
    • Marshfield Clinic
    • Marshfield Wisconsin 54449 United States
    • Saint Joseph's Hospital
    • Marshfield Wisconsin 54449 United States
    • Aurora Cancer Care-Milwaukee
    • Milwaukee Wisconsin 53209 United States
    • Aurora Saint Luke's Medical Center
    • Milwaukee Wisconsin 53215 United States
    • Froedtert and the Medical College of Wisconsin
    • Milwaukee Wisconsin 53226 United States
    • Aurora Sinai Medical Center
    • Milwaukee Wisconsin 53233 United States
    • Marshfield Clinic-Minocqua Center
    • Minocqua Wisconsin 54548 United States
    • Cancer Center of Western Wisconsin
    • New Richmond Wisconsin 54017 United States
    • Green Bay Oncology - Oconto Falls
    • Oconto Falls Wisconsin 54154 United States
    • Vince Lombardi Cancer Clinic - Oshkosh
    • Oshkosh Wisconsin 54904 United States
    • Aurora Cancer Care-Racine
    • Racine Wisconsin 53406 United States
    • Marshfield Clinic at James Beck Cancer Center
    • Rhinelander Wisconsin 54501 United States
    • Saint Mary's Hospital
    • Rhinelander Wisconsin 54501 United States
    • Marshfield Clinic-Rice Lake Center
    • Rice Lake Wisconsin 54868 United States
    • HSHS Saint Nicholas Hospital
    • Sheboygan Wisconsin 53081 United States
    • Vince Lombardi Cancer Clinic-Sheboygan
    • Sheboygan Wisconsin 53081 United States
    • Marshfield Clinic Cancer Care at Saint Michael's Hospital
    • Stevens Point Wisconsin 54481 United States
    • Saint Michael's Hospital
    • Stevens Point Wisconsin 54481 United States
    • Marshfield Clinic Stevens Point Center
    • Stevens Point Wisconsin 54482 United States
    • Saint Vincent Hospital Cancer Center at Sturgeon Bay
    • Sturgeon Bay Wisconsin 54235-1495 United States
    • Green Bay Oncology - Sturgeon Bay
    • Sturgeon Bay Wisconsin 54235 United States
    • Aurora Medical Center in Summit
    • Summit Wisconsin 53066 United States
    • Vince Lombardi Cancer Clinic-Two Rivers
    • Two Rivers Wisconsin 54241 United States
    • Aurora Cancer Care-Waukesha
    • Waukesha Wisconsin 53188 United States
    • Aspirus Regional Cancer Center
    • Wausau Wisconsin 54401 United States
    • Marshfield Clinic-Wausau Center
    • Wausau Wisconsin 54401 United States
    • Aurora Cancer Care-Milwaukee West
    • Wauwatosa Wisconsin 53226 United States
    • Aurora West Allis Medical Center
    • West Allis Wisconsin 53227 United States
    • Diagnostic and Treatment Center
    • Weston Wisconsin 54476 United States
    • Marshfield Clinic - Weston Center
    • Weston Wisconsin 54476 United States
    • Aspirus UW Cancer Center
    • Wisconsin Rapids Wisconsin 54494 United States
    • Marshfield Clinic - Wisconsin Rapids Center
    • Wisconsin Rapids Wisconsin 54494 United States
    • Billings Clinic-Cody
    • Cody Wyoming 82414 United States

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published July 12, 2017
  • A Phase III Randomized Trial of MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial

    {{header-clinical-trials-navigation}}

    A Phase III Randomized Trial of MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial


    Condition: Prostate Cancer, Prostate Adenocarcinoma

    Intervention:

    • Radiation: Standard Salvage Radiation Treatment (SSRT)
    • Radiation: Mapped Tumor Salvage RT (MTSRT)
    • Behavioral: Expanded Prostate Cancer Index Composite-SF12
    • Behavioral: Memory Anxiety Scale for Prostate Cancer patients
    • Behavioral: International Prostate Symptom Score (IPSS)

    Purpose: 1. The investigators hypothesize that increasing radiation dose to the functional MRI-defined lesion in the prostate bed will result in an improved initial complete response (reduction in prostate-specific antigen (PSA) to < 0.1 ng/mL), which is related to long-term outcome biochemically. 2. Biomarker expression levels differ in the DCE-MRI enhancing and non-enhancing tumor regions. 3. 10-15% of men undergoing RT have free circulating DNA (fcDNA) or tumor cells (CTC) that are related to an adverse treatment outcome. 4. Prostate cancer-related anxiety will be reduced in the MRI targeted SRT arm, because the patients will be aware that the dominant tumor will be targeted with higher radiation dose.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01411345

    Sponsor: University of Miami

    Primary Outcome Measures:

    • Measure: Rate of PSA Response to Protocol Therapy
    • Time Frame: 21 months Post-Completion of Protocol Therapy
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Rate of Acute and Late Toxicity
    • Time Frame: Up to 5.25 years post-Protocol Therapy
    • Safety Issue:
    • Measure: Impact of Protocol Therapy on Study Participant Health-Related Quality of Life (HRQOL)
    • Time Frame: Up to 5.25 years post-Protocol Therapy
    • Safety Issue:
    • Measure: Impact of Protocol Therapy on Study Participant Prostate Cancer-Specific Anxiety
    • Time Frame: Up to 5.25 years post-Protocol Therapy
    • Safety Issue:
    • Measure: Impact of Protocol Therapy on Study Participant Prostate Cancer-specific Quality of Life (QOL).
    • Time Frame: Up to 5.25 years post-Protocol Therapy
    • Safety Issue:
    • Measure: Rate of Biochemical and Clinical Failure
    • Time Frame: Up to 5.25 years post-Protocol Therapy
    • Safety Issue:
    • Measure: Rate of Failure-free Survival (FFS)
    • Time Frame: Up to 5.25 years post-Protocol Therapy
    • Safety Issue:
    • Measure: Rate of Overall survival (OS)
    • Time Frame: Up to 5.25 years post-Protocol Therapy
    • Safety Issue:
    • Measure: Measurement of Tissue Biomarker Expression
    • Time Frame: Up to 5.25 years post-Protocol Therapy
    • Safety Issue:
    • Measure: Incidence and relationship of circulating DNA and tumor cells to tissue biomarkers
    • Time Frame: Up to 5.25 years post-Protocol Therapy
    • Safety Issue:

    Estimated Enrollment: 80

    Study Start Date: July 12, 2012

    Eligibility:

    • Age: minimum 35 Years maximum 85 Years
    • Gender: Male

    Inclusion Criteria:

    • A. Prostate cancer patients with a PSA after prostatectomy of at least 0.1 ng/mL and up to 4.0 ng/mL within 3 months prior to enrollment.
    • B. Patients with or without palpable abnormalities on digital rectal exam (DRE) are eligible.
    • C. Minimum of 3 months since prostatectomy to allow for return of urinary continence and healing.
    • D. MRI detectable lesion in prostate bed. DCE-MRI enhancing lesion in the prostate bed should be at least 0.4 cc and a maximum of 6 cc and was obtained ≤ 3 months prior to enrollment.
    • E. No evidence of metastatic (regional or distant) disease on the pelvic MRI.
    • F. Negative bone scan if deemed necessary by treating physician obtained ≤ 4 months prior to enrollment.
    • G. No previous pelvic radiotherapy.
    • H. Serum total testosterone is within 40% of normal assay limits, taken within 34 months prior to enrollment. Patient who have been started on androgen deprivation therapy (ADT) prior to signing consent are not required to have serum testosterone with the range outlined; but, should have a serum testosterone level recorded prior to enrollment.
    • I. No concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for ≥ 5 years then the patient is eligible.
    • J. Ability to understand and the willingness to sign a written informed consent document.
    • K. Zubrod performance status < 2.
    • L. Patients must agree to fill out quality of life/psychosocial questionnaires.
    • M. Age ≥ 35 and ≤ 85 years.

    Exclusion Criteria:

    • A. Prior androgen deprivation therapy is not permitted if it was within 6 months previous to signing consent form. (NOTE: Therapy given as part of the planned course of radiation is allowed).

    Location:

    • University of Miami
    • Miami Florida 33136 United States

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • A Phase III Trial of Hypofractionated External Beam Image-Guided Highly Targeted Radiotherapy: The HEIGHT Trial

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    A Phase III Trial of Hypofractionated External Beam Image-Guided Highly Targeted Radiotherapy: The HEIGHT Trial


    Condition: Prostate Cancer, Prostate Adenocarcinoma

    Intervention:

    • Radiation: SIMRT
    • Radiation: HTIMRT
    • Behavioral: EPIC SF-12 Questionnaire
    • Behavioral: MAX-PC Questionnaire
    • Behavioral: IPSS Questionnaire

    Purpose: 1. Delivery of directed hypofractionated targeted (HT) radiotherapy (RT) tumor boost to the dominant tumor lesion in the prostate as identified by multiparametric MRI will increase tumor eradication from the prostate. 2. Biomarker expression levels differ in the multiparametric MRI defined regions at high risk of harboring tumors that determine outcome. 3. 10-15% of men undergoing RT have Circulating DNA or tumor cells (CTC) that are related to an adverse treatment outcome. 4. Quality of life will not differ significantly between the treatment arms. 5. Prostate cancer-related anxiety will be reduced in the HTIMRT arm, because the patients will be aware that the dominant tumor will be targeted with higher radiation dose.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01411332

    Sponsor: University of Miami

    Primary Outcome Measures:

    • Measure: Rate of prostate biopsy positivity in patients receiving HTIMRT versus patients receiving SIMRT at 2 years after all therapy.
    • Time Frame: 2 years post-therapy
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Rate of acute and late toxicity in patients receiving HTIMRT.
    • Time Frame: 5.25 years
    • Safety Issue:
    • Measure: Rate of influence of HTIMRT on patients' on quality of life.
    • Time Frame: 5.25 years
    • Safety Issue:
    • Measure: Quantification of biomarker expression in different prostate tumor regions.
    • Time Frame: 5.25 years
    • Safety Issue:
    • Measure: Incidence and relationship of circulating free DNA and tumor cells to tissue biomarkers and prostate biopsy positivity.
    • Time Frame: 2 years post-completion of therapy
    • Safety Issue:
    • Measure: Rate of Biochemical Failure, Clinical Failure and Failure-Free Survival (FFS) in Patients
    • Time Frame: 5.25 years
    • Safety Issue:
    • Measure: Rate of Overall Survival (OS)
    • Time Frame: 5.25 years
    • Safety Issue:

    Estimated Enrollment: 72

    Study Start Date: October 31, 2011

    Eligibility:

    • Age: minimum 35 Years maximum 85 Years
    • Gender: Male

    Inclusion Criteria:

    • A. Biopsy confirmed adenocarcinoma of the prostate.
    • B. T1-T3a disease based on digital rectal exam. 1. T1a is permitted if peripheral zone biopsies are positive. 2. T3a disease based on MRI is acceptable.
    • C. No evidence of metastasis by any clinical criteria or available radiographic tests.
    • D. Gleason score 6-8.
    • E. Patients with Gleason score 8 must be offered long term androgen deprivation therapy (ADT) and refuse such treatment because only 4-6 (±2 months) months (short term ADT) is permitted on this protocol. Gleason score ≥ 8 patients should be recommended to receive short term ADT in conjunction with RT. When given, the ADT recommended to begin after fiducial marker placement, if applicable; however, ADT is permitted to have been started up to two months prior to the signing of consent. 1. Patients with Gleason score 8 disease must have <40 of the diagnostic tumor tissue involved with tumor. 2. Patients with Gleason score ≤7 may be treated with 4-6 (±2 months) months of ADT.
    • F. PSA ≤100 ng/mL within 3 months of enrollment. If PSA was above 100 and dropped to ≤100 with antibiotics, this is acceptable for enrollment.
    • G. If PSA is >15 ng/ml or there is ≥ Gleason 8 disease, a bone scan should be obtained ≤4 months before enrollment and should be without evidence of metastasis. A questionable bone scan is acceptable if plain x-rays, CT and/or MRI are negative for metastasis.
    • H. No previous pelvic radiotherapy
    • I. No previous history of radical/total prostatectomy (suprapubic prostatectomy is acceptable)
    • J. No concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for ≥ 5 years then the patient is eligible.
    • K. Identifiable multiparameter functional MRI defined tumor lesion or lesions using a 1.5T or 3.0T MRI (3.0T preferable), that total in volume <33% of the prostate within 3 months prior to enrollment. a. Multiparametric functional including diffusion weighted imaging (DWI) of prostate and pelvis is required prior to protocol consideration
    • L. Ability to understand and the willingness to sign a written informed consent document
    • M. Zubrod performance status <2 (Karnofsky or Eastern Cooperative Oncology Group (ECOG) performance status may be used to estimate Zubrod)
    • N. Willingness to fill out quality of life/psychosocial forms.
    • O. Age ≥35 and ≤85 years.
    • P. Serum testosterone is within 40% of normal assay limits (e.g., x=0.4*lower assay limit and x=.04*upper assay limit + upper assay limit),, taken within 4 months of enrollment. Patients who have been started on ADT prior to signing consent are not required to have a serum testosterone at this level prior to signing consent; but, a serum testosterone prior to fiducial marker placement is recommended.
    • Q. Serum liver function tests (LFTs) taken within 3 months of enrollment.
    • R. Complete blood counts taken within 3 months of enrollment.

    Exclusion Criteria:

    • A. Previous pelvic radiotherapy.
    • B. Previous history of radical prostatectomy.
    • C. Concurrent, active malignancy, which is not nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for < 5 years then the patient is not eligible
    • D. Not willing to fill out quality of life/psychosocial questionnaires.

    Location:

    • University of Miami
    • Miami Florida 33136 United States

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • A Phase III, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostate Cancer After Failure of an Androgen Synthesis Inhibitor a

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    A Phase III, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostate Cancer After Failure of an Androgen Synthesis Inhibitor and Failure of, Ineligibility for, or Refusal of a Taxane Regimen


    Condition: Prostatic Neoplasms, Castration-Resistant

    Intervention:

    • Drug: Atezolizumab
    • Drug: Enzalutamide

    Purpose: This Phase III, multicenter, randomized, open-label study will evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) in combination with enzalutamide compared with enzalutamide alone in participants with mCRPC after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of, ineligibility for, or refusal of a taxane regimen. Participants will be randomized to one of the two treatment arms (atezolizumab in combination with enzalutamide, and enzalutamide alone) in a 1:1 ratio (experimental to control arm) in global randomized phase. Participants will receive treatment until investigator-assessed confirmed radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03016312

    Sponsor: Hoffmann-La Roche

    Primary Outcome Measures:

    • Measure: Overall surivival (OS)
    • Time Frame: Baseline until death from any cause (up to approximately 42 months)
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Percentage of Participants who Survived at Month 12 and 24
    • Time Frame: Months 12, 24
    • Safety Issue:
    • Measure: Time to Cancer-Related Pain Progression, as Assessed Using Modified Brief Pain Inventory (BPI)
    • Time Frame: Baseline until disease progression (up to approximately 42 months)
    • Safety Issue:
    • Measure: Time to First Symptomatic Skeletal Event (SSE)
    • Time Frame: Baseline up to end of study (up to approximately 42 months)
    • Safety Issue:
    • Measure: Radiographic Progression-Free Survival (rPFS), as Assessed by the Investigator and Adapted From the PCWG3 Criteria
    • Time Frame: Baseline until disease progression or death from any cause (up to approximately 42 months)
    • Safety Issue:
    • Measure: Percentage of Participants Who are Radiographic Progression-Free, as Assessed by the Investigator and Adapted From the PCWG3 Criteria
    • Time Frame: Months 6, 12
    • Safety Issue:
    • Measure: Immune-Modified rPFS, as Assessed by the Investigator as per PCWG3 Criteria and Immune-Modified Response Evaluation Criteria in Solid Tumors (RECIST)
    • Time Frame: Baseline until disease progression or death from any cause (up to approximately 42 months)
    • Safety Issue:
    • Measure: Percentage of Participants With Greater Than (>) 50 Percent (%) Decrease in Prostate-Specific Antigen (PSA) From Baseline
    • Time Frame: Baseline until disease progression (up to approximately 42 months)
    • Safety Issue:
    • Measure: Time to PSA Progression, Assessed as per PCWG3 Criteria
    • Time Frame: Baseline until disease progression (up to approximately 42 months)
    • Safety Issue:
    • Measure: Percentage of Participant With Objective Response, as Determined by the Investigator Through use of PCWG3 Criteria
    • Time Frame: Baseline until disease progression or death from any cause (up to approximately 42 months)
    • Safety Issue:
    • Measure: Percentage of Participant With Objective Response, as Determined by the Investigator Through use of Immune-Modified RECIST
    • Time Frame: Baseline until disease progression or death from any cause (up to approximately 42 months)
    • Safety Issue:
    • Measure: Percentage of Participants With Adverse Events
    • Time Frame: Baseline up to end of study (up to approximately 42 month
    • Safety Issue:
    • Measure: Minimum Observed Serum Concentration (Cmin) of Atezolizumab
    • Time Frame: Pre-infusion (0 hour[hr]) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); treatment discontinuation visit, 120 days after last dose (up to approximately 42 months)
    • Safety Issue:
    • Measure: Maximum Observed Serum Concentration (Cmax) of Atezolizumab
    • Time Frame: Pre-infusion (0 hr) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); 0.5 hr post-infusion (infusion duration: 60 minutes [min]) on Day 1 Cycle 1; treatment discontinuation visit, 120 days after last dose (up to approximately 42 months)
    • Safety Issue:
    • Measure: Plasma Concentration of Enzalutamide
    • Time Frame: Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8
    • Safety Issue:
    • Measure: Plasma Concentration of N-Desmethyl Enzalutamide
    • Time Frame: Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8
    • Safety Issue:
    • Measure: Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
    • Time Frame: Predose (0 hr) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); at atezolizumab discontinuation visit (30 days after last dose); 120 days after last dose of atezolizumab; up to 42 months
    • Safety Issue:
    • Measure: Time to Initiation or Increased Opiate Analgesic Use
    • Time Frame: Baseline up to end of study (up to approximately 42 months)
    • Safety Issue:

    Estimated Enrollment: 730

    Study Start Date: January 10, 2017

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Life expectancy greater than or equal to (>/=) 3 months
    • Histologically confirmed adenocarcinoma of the prostate
    • Known castrate-resistant disease with serum testosterone level less than or equal to (
    • Progressive disease prior to screening by PSA or imaging per PCWG3 criteria during or following the direct prior line of therapy in the setting of medical or surgical castration
    • One prior regimen/line of a taxane-containing regimen for mCRPC or refusal or ineligibility of a taxane-containing regimen
    • Progression on a prior regimen/line of an androgen synthesis inhibitor for prostate cancer
    • Availability of a representative tumor specimen from a site not previously irradiated that is suitable for determination of programmed death-ligand 1 (PD-L1) status via central testing
    • Adequate hematologic and end organ function

    Exclusion Criteria:

    • Prior treatment with enzalutamide or any other newer hormonal androgen receptor inhibitor (e.g., apalutamide, ODM-201)
    • Treatment with any approved anti-cancer therapy, including chemotherapy, immunotherapy, radiopharmaceutical or hormonal therapy (with the exception of abiraterone), within 4 weeks prior to initiation of study treatment
    • Treatment with abiraterone within 2 weeks prior to study treatment
    • Structurally unstable bone lesions suggesting impending fracture
    • Known or suspected brain metastasis or active leptomeningeal disease
    • Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study
    • Active or history of autoimmune disease or immune deficiency
    • Prior allogeneic stem cell or solid organ transplantation
    • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
    • Positive human immunodeficiency virus (HIV) test, active tuberculosis, active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
    • Prior treatment with cluster of differentiation (CD)137 agonists or immune checkpoint blockade therapies, including anti Cytotoxic T Lymphocyte-Associated 4 (CTLA4), anti-programmed death 1 (PD-1), and anti-PD-L1 therapeutic antibodies
    • Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to initiation of study treatment
    • Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study
    • History of seizure or any condition that may predispose to seizure within 12 months prior to study treatment, including history of unexplained loss of consciousness or transient ischemic attack

    Contact:

    • Reference Study ID Number: CO39385 www.roche.com/about_roche/roche_worldwide.htm
    • 888-662-6728 (U.S. and Canada)

    Locations:

    • City of Hope Medical Grp Inc.
    • Duarte California 91010 United States
    • University of California San Diego
    • La Jolla California 92093 United States
    • Kaiser Permanente San Diego - Los Angeles
    • Los Angeles California 90027 United States
    • USC Norris Cancer Center
    • Los Angeles California 90033 United States
    • USC/Westside Cancer Ctr
    • Los Angeles California 90033 United States
    • Prostate Oncology Specialists
    • Marina Del Rey California 90292 United States
    • UC Irvine Medical Center
    • Orange California 92868 United States
    • Pacific Hematology Oncology Assocociates
    • San Francisco California 94115 United States
    • University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center
    • San Francisco California 94158 United States
    • University of Colorado; Division of Medical Oncology
    • Aurora Colorado 80045 United States
    • University of Connecticut Health Center
    • Farmington Connecticut 06030 United States
    • Hartford Hospital
    • Hartford Connecticut 06102 United States
    • Yale School of Medicine
    • New Haven Connecticut 06510 United States
    • Stamford Hospital; BCC, MOHR
    • Stamford Connecticut 06904 United States
    • Lynn Cancer Institute/Boca Raton Regional Hospital
    • Boca Raton Florida 33486 United States
    • SCRI Florida Cancer Specialists South
    • Fort Myers Florida 33916 United States
    • Baptist Health Medical Group Oncology, LLC
    • Miami Florida 33176 United States
    • Florida Cancer Specialist, North Region
    • Saint Petersburg Florida 33705 United States
    • SCRI Florida Cancer Specialists East
    • Tallahassee Florida 32308 United States
    • Investigative Clin Rsch of IN
    • Indianapolis Indiana 46260 United States
    • Associates in Oncology/Hematology P.C.
    • Rockville Maryland 20850 United States
    • Massachusetts General Hospital
    • Boston Massachusetts 02114 United States
    • Beth Israel Deaconess Medical Center
    • Boston Massachusetts 02215 United States
    • Dana-Farber Cancer Institute
    • Boston Massachusetts 02215 United States
    • Karmanos Cancer Institute..
    • Detroit Michigan 48201 United States
    • HCA Midwest Division
    • Kansas City Missouri 64132 United States
    • St. Vincent Frontier Cancer Center
    • Billings Montana 59101 United States
    • Nebraska Cancer Specialists; Oncology Hematology West, PC
    • Omaha Nebraska 68130 United States
    • Urology Cancer Center & GU Research Network
    • Omaha Nebraska 68130 United States
    • Comprehensive Cancer Centers of Nevada
    • Las Vegas Nevada 89128 United States
    • MSKCC at Basking Ridge
    • Basking Ridge New Jersey 07920 United States
    • MD Anderson Cancer Center at Cooper
    • Camden New Jersey 8103 United States
    • Hunterdon Medical Center
    • Flemington New Jersey 08822 United States
    • New York Oncology Hematology, P.C.
    • Albany New York 12208 United States
    • MSKCC @ Commack
    • Commack New York 11725 United States
    • MSKCC @ West Harrison
    • Harrison New York 10604 United States
    • Columbia University Medical Center
    • New York New York 10032 United States
    • Memorial Sloan-Kettering Cancer Center
    • New York New York 10065 United States
    • MSKC @ Rockville
    • Rockville Centre New York 11570 United States
    • Oncology Hematology Care, Inc.
    • Cincinnati Ohio 45230 United States
    • James Cancer Hospital;Solove Research Institute
    • Columbus Ohio 43210 United States
    • Good Samaritan North Health Center
    • Dayton Ohio 45415 United States
    • Willamette Valley Cancer Ctr - 520 Country Club
    • Eugene Oregon 97401-8122 United States
    • Lehigh Valley Health Network
    • Allentown Pennsylvania 18103 United States
    • Penn State Milton S. Hershey Medical Center
    • Hershey Pennsylvania 17033 United States
    • University of Pennsylvania Health System; Cancer Center
    • Philadelphia Pennsylvania 19104 United States
    • Allegheny Cancer Center
    • Pittsburgh Pennsylvania 15212 United States
    • University of Pittsburgh Cancer Institute; Division of Medical Oncology
    • Pittsburgh Pennsylvania 15232 United States
    • Miriam Hospital
    • Providence Rhode Island 02906 United States
    • Charleston Hematology Oncology
    • Charleston South Carolina 29414 United States
    • Carolina Urologic Research Center
    • Myrtle Beach South Carolina 29572 United States
    • SCRI Tennessee Oncology Chattanooga
    • Chattanooga Tennessee 37404 United States
    • Tennessee Onc., PLLC - SCRI
    • Nashville Tennessee 37203 United States
    • Vanderbilt University Medical Center
    • Nashville Tennessee 37232 United States
    • Texas Oncology Cancer Center
    • Austin Texas 78731 United States
    • Texas Oncology - Methodist Dallas Cancer Center
    • Dallas Texas 75203 United States
    • Texas Oncology, P.A. - Fort Worth
    • Fort Worth Texas 76104 United States
    • Texas Oncology - Memorial City
    • Houston Texas 77024 United States
    • Texas Oncology-Tyler
    • Irving Texas 75063 United States
    • Virginia Cancer Specialists - Alexandria
    • Alexandria Virginia 22304 United States
    • Virginia Oncology Associates
    • Norfolk Virginia 23502 United States
    • Eastern Health; Cancer Services
    • Box Hill New South Wales 3128 Australia
    • Concord Repatriation General Hospital; Concord Cancer Centre
    • Concord New South Wales 2139 Australia
    • Macquarie University Hospital
    • Sydney New South Wales 2109 Australia
    • Royal Brisbane & Women's Hosp; Cancer Care Serv
    • Herston Queensland 4029 Australia
    • Adelaide Cancer Centre
    • Kurralta Park South Australia 5037 Australia
    • Monash Medical Centre; Oncology
    • Clayton Victoria 3168 Australia
    • St Vincents Hospital
    • Melbourne Victoria 3065 Australia
    • LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
    • Graz 8036 Austria
    • Ordensklinikum Linz Barmherzige Schwestern; Urologie
    • Linz 4010 Austria
    • Medizinische Universität Wien; Universitätsklinik für Urologie
    • Wien 1090 Austria
    • Onze Lieve Vrouwziekenhuis Aalst
    • Aalst 9300 Belgium
    • UZ Gent
    • Gent 9000 Belgium
    • CHU Sart-Tilman
    • Liège 4000 Belgium
    • Tom Baker Cancer Centre-Calgary
    • Calgary Alberta T2N 4N2 Canada
    • Kingston General Hospital
    • Kingston Ontario K7L 2V6 Canada
    • Lakeridge Health Oshawa; Oncology
    • Oshawa Ontario L1G 2B9 Canada
    • Sunnybrook Research Institute
    • Toronto Ontario M4N 3M5 Canada
    • Princess Margaret Cancer Center
    • Toronto Ontario M5G 1Z5 Canada
    • Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie
    • Greenfield Park Quebec J4V 2H1 Canada
    • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
    • Montreal Quebec H3T 1E2 Canada
    • CHU de Québec - Université Laval - Hôtel-Dieu de Québec
    • Québec Quebec G1R 2J6 Canada
    • CHUS (Centre Hospitalier Universitaire de Sherbrooke)
    • Sherbrooke Quebec J1H 5N4 Canada
    • Peking University First Hospital
    • Beijing 100034 China
    • Friendship Hospital, Capital Medical University
    • Beijing 100050 China
    • Beijing Hospital of Ministry of Health
    • Beijing 100730 China
    • Chongqing Cancer Hospital
    • Chongqing 400030 China
    • Sun Yat-sen Memorial Hospital
    • Guangzhou 510000 China
    • Jiangsu Cancer Hospital
    • Nanjing 210009 China
    • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
    • Nanjing 210029 China
    • Fudan University Shanghai Cancer Center
    • Shanghai 200032 China
    • Zhongshan Hospital Fudan University
    • Shanghai 200032 China
    • The 2nd Hospital of Tianjin Medical University
    • Tianjin 201203 China
    • Masarykuv onkologicky ustav
    • Brno 656 53 Czechia
    • Fakultni nemocnice u sv. Anny v Brne
    • Brno 656 91 Czechia
    • Urocentrum Praha s.r.o.
    • Praha 2 120 00 Czechia
    • Thomayerova nemocnice
    • Praha 4 - Krc 140 59 Czechia
    • Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.
    • Aalborg 9000 Denmark
    • Aarhus Universitetshospital; Kræftafdelingen
    • Aarhus N 8200 Denmark
    • Herlev Hospital; Onkologisk afdeling
    • Herlev 2730 Denmark
    • Odense Universitetshospital, Onkologisk Afdeling R
    • Odense C 5000 Denmark
    • Institut de Cancerologie de l Ouest
    • Angers 49055 France
    • Institut Sainte-Catherine; Oncologie
    • Avignon 84082 France
    • CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre
    • Bordeaux 33075 France
    • Centre Francois Baclesse; Oncologie
    • Caen 14076 France
    • Hopital Louis Pasteur; Medecine B
    • Colmar 68024 France
    • Centre Oscar Lambret; Chir Cancerologie General
    • Lille 59000 France
    • Clinique Chenieux; Oncology
    • Limoges 87039 France
    • Centre Leon Berard; Departement Oncologie Medicale
    • Lyon 69373 France
    • Hopital Saint Louis, Service D Oncologie Medicale
    • Paris 75475 France
    • Hopital d'Instruction des Armees de Begin
    • Saint-Mande 94160 France
    • Institut Claudius Regaud; Departement Oncologie Medicale
    • Toulouse 31059 France
    • Institut Gustave Roussy
    • Villejuif 94805 France
    • Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie
    • Berlin 12200 Germany
    • Städtisches Klinikum Braunschweig gGmbH, Klinik für Urologie und Uroonkologie
    • Braunschweig 38126 Germany
    • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
    • Dresden 01307 Germany
    • Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie
    • Freiburg 79106 Germany
    • Martini-Klinik am UKE GmbH
    • Hamburg 20246 Germany
    • Medizinische Hochschule Hannover; Klinik für Urologie und Onkologische Urologie
    • Hannover 30625 Germany
    • Universitätsklinikum Heidelberg, Chirurgische Klinik, Klinik für Urologie
    • Heidelberg 69120 Germany
    • Uniklinik Köln, Klinik für Urologie, Uro-Onkologie und spezielle urologische Chirurgie
    • Köln 50937 Germany
    • Universitätsklinikum Magdeburg A.ö.R., Klinik f. Urologie u. Kinderurologie
    • Magdeburg 39120 Germany
    • Klinik der Philipps-Universität; Urologie und Kinderurologie
    • Marburg 35043 Germany
    • Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
    • München 81675 Germany
    • Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie
    • Münster 48149 Germany
    • Klinikum Nürnberg 5. Medizinische Klinik Hämatologie/Onkologie Universitätsklinik der Paracelsus
    • Nürnberg 90419 Germany
    • Universitätsklinikum Tübingen; Klinik für Urologie
    • Tübingen 72076 Germany
    • Urologisches Zentrum Euregio; Urologische Praxis am Wasserturm
    • Würselen 52146 Germany
    • Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
    • Athens 115 22 Greece
    • Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine
    • Athens 115 28 Greece
    • Athens Medical Center; Dept. of Oncology
    • Athens 151 25 Greece
    • IASO General Hospital of Athens
    • Athens 155 62 Greece
    • Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
    • Kifisia 145 64 Greece
    • University Hospital of Patras Medical Oncology
    • Patras 265 04 Greece
    • Papageorgiou General Hospital; Medical Oncology
    • Thessaloniki 546 29 Greece
    • Semmelwies University of Medicine; Urology Dept.
    • Budapest 1082 Hungary
    • Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
    • Budapest 1122 Hungary
    • Uzsoki Utcai Korhaz
    • Budapest 1145 Hungary
    • Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
    • Debrecen 4032 Hungary
    • ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
    • Napoli Campania 80131 Italy
    • I.R.S.T Srl IRCCS; Oncologia Medica
    • Meldola Emilia-Romagna 47014 Italy
    • A.O. Universitaria Policlinico Di Modena; Oncologia
    • Modena Emilia-Romagna 41100 Italy
    • Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
    • Roma Lazio 00152 Italy
    • IRCCS AOU San Martino - IST; Oncologia Medica 1
    • Genova Liguria 16132 Italy
    • A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia
    • Cremona Lombardia 26100 Italy
    • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
    • Milano Lombardia 20133 Italy
    • Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche
    • Milano Lombardia 20141 Italy
    • Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
    • Bari Puglia 70124 Italy
    • IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
    • San Giovanni Rotondo Puglia 71013 Italy
    • Ospedale Area Aretina Nord; U.O.C. Oncologia
    • Arezzo Toscana 52100 Italy
    • Ospedale di Trento-Presidio Ospedaliero Santa Chiara; Oncologia Medica
    • Trento Trentino-Alto Adige 38122 Italy
    • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
    • Padova Veneto 35128 Italy
    • Nagoya City University Hospital
    • Aichi 467-8602 Japan
    • National Cancer Center East
    • Chiba 277-8577 Japan
    • Toho University Sakura Medical Center
    • Chiba 285-8741 Japan
    • Kyushu University Hospital
    • Fukuoka 812-8582 Japan
    • National Hospital Organization Hokkaido Cancer Center
    • Hokkaido 003-0804 Japan
    • Yokohama City University Medical Center
    • Kanagawa 232-0024 Japan
    • Kitasato University Hospital
    • Kanagawa 252-0375 Japan
    • University Hospital Kyoto Prefectural University of Medicine
    • Kyoto 602-8566 Japan
    • Nara Medical University Hospital
    • Nara 634-8522 Japan
    • Niigata University Medical & Dental Hospital
    • Niigata 951-8520 Japan
    • Kansai Medical University Hospital
    • Osaka 573-1191 Japan
    • Toranomon Hospital
    • Tokyo 105-8470 Japan
    • The Jikei University Hospital
    • Tokyo 105-8471 Japan
    • Nippon Medical School Hospital
    • Tokyo 113-8603 Japan
    • National Cancer Center
    • Gyeonggi-do 10408 Korea, Republic of
    • Seoul National University Hospital
    • Seoul 03080 Korea, Republic of
    • Asan Medical Center
    • Seoul 05505 Korea, Republic of
    • Samsung Medical Center
    • Seoul 6351 Korea, Republic of
    • Medical University of Bialystok; Oncology clinic
    • Bialystok 15-027 Poland
    • Przychodnia Lekarska KOMED
    • Konin 62-500 Poland
    • Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
    • Krakow 31-531 Poland
    • SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego
    • Opole 45-060 Poland
    • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
    • Otwock 05-400 Poland
    • Szpital Sw. Elzbiety - Mokotowskie Centrum Medyczne Sp. z o.o.
    • Warszawa 02-616 Poland
    • Wojewodzki Szpital; Specjalistyczny ul.
    • Wroclaw 51-124 Poland
    • Woj. Wielospecjalistyczne Centrum Onkologii i Traumatologii; Pododdzial Chemioter. Jednego Dnia
    • Łódź 93-513 Poland
    • SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
    • Sankt-peterburg Leningrad 197022 Russian Federation
    • Blokhin Cancer Research Center; Urological Dept
    • Moscow 115478 Russian Federation
    • Russian Scientific Center of Roentgenoradiology
    • Moscow 117997 Russian Federation
    • P.A. Herzen Oncological Inst. ; Oncology
    • Moscow 125284 Russian Federation
    • Institut Catala d´Oncologia Hospital Germans Trias i Pujol
    • Badalona Barcelona 08916 Spain
    • Insititut Catala D'Oncologia
    • Hospitalet de Llobregat Barcelona 08908 Spain
    • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
    • Sabadell Barcelona 08208 Spain
    • Hospital Universitario Reina Sofia; Servicio de Oncologia
    • Córdoba Cordoba 14004 Spain
    • Hospital Universitario Son Espases; Servicio de Oncologia
    • Palma De Mallorca Islas Baleares 07014 Spain
    • Clinica Universitaria de Navarra; Servicio de Oncologia
    • Pamplona Navarra 31008 Spain
    • Hospital Universitari Vall d'Hebron; Oncology
    • Barcelona 08035 Spain
    • Hospital Clínic i Provincial; Servicio de Oncología
    • Barcelona 08036 Spain
    • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
    • Barcelona 08041 Spain
    • Hospital Ramon y Cajal; Servicio de Oncologia
    • Madrid 28034 Spain
    • Hospital Clinico San Carlos; Servicio de Oncologia
    • Madrid 28040 Spain
    • Hospital Universitario 12 de Octubre; Servicio de Oncologia
    • Madrid 28041 Spain
    • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
    • Malaga 29010 Spain
    • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
    • Sevilla 41013 Spain
    • Inselspital Bern; Universitätsklinik für medizinische Onkologie
    • Bern 3010 Switzerland
    • Kantonsspital St. Gallen; Onkologie/Hämatologie
    • St. Gallen 9007 Switzerland
    • Taichung Veterans General Hospital; Division of Urology
    • Taichung 407 Taiwan
    • National Taiwan University Hospital, Department of Urology
    • Taipei 10048 Taiwan
    • TAIPEI VETERANS GENERAL HOSPITAL, Urology
    • Taipei 11217 Taiwan
    • Chang Gung Memorial Hospital-LinKou; Urology
    • Taoyuan 333 Taiwan
    • Queen Elizabeth Hospital
    • Birmingham B15 2TH United Kingdom
    • Royal Blackburn Hospital
    • Blackburn BB2 3HH United Kingdom
    • BRISTOL ONCOLOGY CENTRE; CLINICAL TRIALS UNIT; R & D department
    • Bristol BS2 8HW United Kingdom
    • Leicester Royal Infirmary
    • Leicester LE1 5WW United Kingdom
    • Barts and the London NHS Trust.
    • London EC1A 7BE United Kingdom
    • Sarah Cannon Research Institute
    • London W1G 6AD United Kingdom
    • The Christie NHS Foundation Trust
    • Manchester M20 4BX United Kingdom
    • Royal Marsden Hospital; Institute of Cancer Research
    • Sutton SM2 5PT United Kingdom

    View trial on ClinicalTrials.gov


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    Published August 1, 2017
  • A Pilot Presurgical Study of Daratumumab (CD38 Antagonist) in Men With High-Risk Localized Prostate Cancer Followed by Radical Prostatectomy

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    A Pilot Presurgical Study of Daratumumab (CD38 Antagonist) or JNJ-40346527 in Men With High-Risk Localized Prostate Cancer Followed by Radical Prostatectomy


    Condition: Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Testosterone Greater Than 150 ng/dL

    Intervention:

    • Biological: Daratumumab
    • Drug: FMS Inhibitor JNJ-40346527
    • Procedure: Radical Prostatectomy

    Purpose: This phase I trial studies the side effects of daratumumab or FMS inhibitor JNJ-40346527 before surgery in treating patients with high-risk prostate cancer that can be removed by surgery and has not spread to other parts of the body or has spread to nearby tissue or lymph nodes. Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spreadFMS inhibitor JNJ-40346527 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving daratumumab or FMS inhibitor JNJ-40346527 before surgery may work better in treating patients with prostate cancer.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03177460

    Sponsor: M.D. Anderson Cancer Center

    Primary Outcome Measures:

    • Measure: Incidence of adverse events
    • Time Frame: Up to week 18
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Pathological complete response (CR)
    • Time Frame: Up to week 18
    • Safety Issue:
    • Measure: Immune changes in blood
    • Time Frame: Baseline up to week 18
    • Safety Issue:
    • Measure: Immune changes in tumor tissue
    • Time Frame: Baseline up to week 18
    • Safety Issue:

    Estimated Enrollment: 30

    Study Start Date: June 7, 2017

    Phase: Phase 1

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Consent to MD Anderson laboratory protocol PA13-0291.
    • Histological documentation of adenocarcinoma of the prostate reviewed at MD Anderson Cancer Center. Patients with small cell, neuroendocrine, or transitional cell carcinomas are not eligible.
    • Patients with high-risk prostate cancer (at least 1 core with Gleason sum >= 8) must have at least three core biopsies involved with cancer (a minimum of 6 core biopsies, must be obtained at baseline). A prostate biopsy within 3 months from screening is allowed for entry requirements.
    • No evidence of metastatic disease as documented by technetium-99m (99mTc) bone scan and by computed tomography (CT) or magnetic resonance imaging (MRI) scans.
    • Eugonadal state (serum testosterone > 150 ng/dL).
    • Localized or locally advanced disease deemed by the surgeon to be resectable. Patients must be appropriate candidates for radical prostatectomy plus pelvic lymph node dissection.
    • No prior treatment for prostate cancer including prior surgery (excluding transurethral resection of the prostate [TURP]), cryoablation, pelvic lymph node dissection, radiation therapy, hormonal therapy or chemotherapy.
    • To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. If the subject is engaged in sexual activity with a woman of childbearing potential, a condom is required along with another effective contraceptive method consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies and their partners. Donation of sperm is not allowed while on study drug and for 3 months following the last dose of study drug.
    • Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of 0 or 1.
    • AT SCREENING: Hemoglobin within institutional normal limits. Administration of growth factors or blood transfusions will not be allowed to confirm eligibility.
    • AT SCREENING: Platelet count within institutional normal limits. Administration of growth factors or blood transfusions will not be allowed to confirm eligibility.
    • AT SCREENING: Absolute neutrophil count within institutional normal limits. Administration of growth factors or blood transfusions will not be allowed to confirm eligibility.
    • AT SCREENING: Absolute lymphocyte count within institutional normal limits. Administration of growth factors or blood transfusions will not be allowed to confirm eligibility.
    • AT SCREENING: Serum chemistries, renal and liver panels within institutional normal limits or meets the requirements for radical prostatectomy.
    • Each subject must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study.

    Exclusion Criteria:

    • Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists/antagonists.
    • Currently enrolled in another interventional study.
    • Concurrent treatment with systemic corticosteroids (prednisone dose > 10 mg per day or equivalent) or other immunosuppressive drugs < 14 days prior to treatment initiation. Steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are permitted.
    • History of or known or suspected autoimmune disease (exception[s]: subjects with vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at screening are allowed).
    • Known evidence of an active infection requiring systemic therapy such as human immunodeficiency virus (HIV), active hepatitis, or fungal infection.
    • History of clinically significant cardiovascular disease including, but not limited to:
    • Myocardial infarction or unstable angina =< 6 months prior to treatment initiation.
    • Clinically significant cardiac arrhythmia.
    • Deep vein thrombosis, pulmonary embolism, stroke =< 6 months prior to treatment initiation.
    • Congestive heart failure (New York Heart Association class III-IV).
    • Pericarditis/clinically significant pericardial effusion.
    • Myocarditis.
    • Endocarditis.
    • History of major implant(s) or device(s), including but not limited to:
    • Prosthetic heart valve(s).
    • Artificial joints and prosthetics placed =< 12 months prior to treatment initiation.
    • Current or prior history of infection or other clinically significant adverse event associated with an exogenous implant or device that cannot be removed.
    • Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) =< 2 years prior to enrollment.
    • Any medical, psychological or social condition that in the opinion of the investigator, would preclude participation in this study.
    • DARATUMUMAB ONLY: Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [antiHBc] and/or antibodies to hepatitis B surface antigen [antiHBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (antiHBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV deoxyribonucleic acid (DNA) by PCR. Seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy)

    Contact:

    • Sumit K. Subudhi, MD, PHD
    • 713-563-1602

    Location:

    • M D Anderson Cancer Center
    • Houston Texas 77030 United States

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • A Pilot Study of Geriatric Specific Interventions for Quality of Life in Elderly Patients With Cancer

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    A Pilot Study of Geriatric Specific Interventions for Quality of Life in Elderly Patients With Cancer


    Condition: Breast Cancer, Prostate Cancer, Lung Cancer, Lymphoma Cancer, Gynecological Cancers

    Intervention:

    • Behavioral: group intervention and questionnaires
    • Behavioral: individual phone intervention and questionnaires
    • Behavioral: expressive writing (arm will not be include in the randomization)

    Purpose: The purpose of this study is to examine whether psychoeducation counseling for older cancer patients undergoing treatment is feasible and worthwhile. The investigators will test this in a group or individual phone counseling format. Many cancer patients seek counseling to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. This geriatric-specific psychoeducation is intended to help older cancer patients cope with the burden of cancer and aging. The purpose of this study is to see if this type of counseling helps reduce depressive symptoms, anxiety, perception of loneliness and isolation. In addition this counseling aims to improve coping and quality of life (QOL). Individuals who choose not to take part in the intervention study will be asked if they are willing to participate in a brief refusal sub study. The purpose of the refusal substudy is to compare levels of distress in patients that choose to participate and those that decline. This will yield valuable data that will help us distinguish between patients that decline due to lack of interest in research and those that decline due to high levels of distress. Participation in the refusal sub study consists of completion of 2 brief questionnaires.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT00984321

    Sponsor: Memorial Sloan Kettering Cancer Center

    Primary Outcome Measures:

    • Measure: To test the feasibility, tolerability and acceptability of a Geriatric Specific Psychoeducational Intervention (GSPI) by examining the rates of eligibility, acceptance, and adherence.
    • Time Frame: 2 years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: To examine the impact of these GSPI in both formats on depressive symptoms, anxiety, demoralization, coping, loneliness and isolation, and spirituality compared to the control group.
    • Time Frame: 2 years
    • Safety Issue:

    Estimated Enrollment: 126

    Study Start Date: September 2009

    Eligibility:

    • Age: minimum 70 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • Have a diagnosis of prostate, breast cancer lung, lymphoma, or gynecological.
    • Are receiving active treatment (e.g., radiation, hormone, or chemotherapy)or have been receiving treatment in the past 6 months for prostate, breast, lung, lymphoma, or gynecological cancer
    • Are 70 years old or older
    • Greater than 6-months post diagnosis
    • Have a Distress Thermometer score of 4 or greater or a score of ≥ 6 on the Depression or Anxiety subscale of the HADS
    • Have a Karnofsky Performance Rating of 60 or greater
    • In the investigator's judgment, participants must have satisfactory cognitive function to provide valid informed consent and participate in Geriatric Specific Psychoeducational Intervention. The Blessed Orientation-Memory-Concentration test (BOMC) will be used as a cognitive screening tool. Patients must have a BOMC score of less than or equal to 11.
    • Able to converse, write and read in English. The questionnaires were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require a very lengthy process of reestablishing the reliability and validity and the establishment of norms for these measures. Therefore, participants must be able to communicate in English to complete the questionnaires.

    Exclusion Criteria:

    • Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in the intervention (e.g., acute psychiatric symptoms which requires individual treatment).
    • As per self-report or review of the patient's medical record, if the patient is taking anti-depressant medication, fewer than three months on the same dose of anti-depressant medication.
    • Actively participating in protocol 07-094 or 11-021

    Contact:

    • Andrew Roth, MD
    • 646-888-0024

    Locations:

    • Memorial Sloan Kettering Cancer Center
    • New York New York 10065 United States
    • Joan Karnell Cancer Center at Pennsylvania
    • Philadelphia Pennsylvania 19106 United States

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • A Pilot Study of High Dose Rate Brachytherapy in The Radiation Oncology Branch

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    A Pilot Study of High Dose Rate Brachytherapy in The Radiation Oncology Branch


    Condition: Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Prostate Cancer, Biliary Cancer

    Intervention:

    • Radiation: Brachytherapy

    Purpose: Background: - One standard way of giving radiation is to combine external beam treatments with internal brachytherapy treatments, which involve short-range radiation therapy that gives a high dose of radiation directly to a cancer or to the area where cancer cells were removed. - Brachytherapy is done by placing hollow implant device(s) into the area to be treated and then moving a radiation source into each. The type of device depends on the type of cancer and the site to be treated. These devices can range from hollow applicators and needles to balloon-like equipment. Objectives: - To evaluate the quality of the brachytherapy procedure at the National Institutes of Health s Radiation Oncology Branch. Eligibility: - Patients with cancer who could potentially benefit from high-dose brachytherapy as part of their treatment. Design: - In conjunction with their existing treatment, patients will be treated with high-dose brachytherapy as determined appropriate for their particular type of cancer and cancer history. - Each treatment will take place in the Radiation Oncology Clinic. - If the patient does not have implant devices, the clinic staff will insert them and check their placement through a computed tomography (CT) scan. - The calculations to determine the appropriate brachytherapy dose will take a few hours; the brachytherapy treatment itself will take between 10 and 30 minutes. - The number of brachytherapy treatments will vary according to the individual needs and requirements of each type of cancer and each patient. - Patients will return to the Radiation Oncology Clinic for followup visits at 1, 3, 6, 9, and 12 months after the completion of radiation therapy. Followup evaluations will include a medical history and physical examination, assessment of any side effects of radiation therapy, and a repeat of any imaging (i.e., CT, MRI, X-ray) that was done at baseline to evaluate the tumor response.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT00924027

    Sponsor: National Cancer Institute (NCI)

    Primary Outcome Measures:

    • Measure: To determine the quality of high dose rate brachytherapy implants performed in the radiation oncology branch.
    • Time Frame: Completion of treatment
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: To evaluate local control and late toxicity rates following brachytherapy at NCI ROB.
    • Time Frame: Completion of study
    • Safety Issue:
    • Measure: To increase the flow of oncology patients requiring brachytherapy to the NCI ROB. As these patients lend themselves to special study and have unique educational value for the purpose of educating nurses, medical students, residents, physicist...
    • Time Frame: Completion of study
    • Safety Issue:

    Estimated Enrollment: 112

    Study Start Date: April 14, 2009

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum 90 Years
    • Gender: All

    Inclusion Criteria:

    • 1. Pathologically confirmed malignancy for which high-dose rate brachytherapy is appropriate as a component of their therapeutic regimen. 2. Age greater than 18 years of age. 3. ECOG performance status of 0, 1, or 2. 4. Patient must have a primary medical or surgical oncologist in the community or at NCI who is willing to collaborate with the ROB staff in the clinical management of the patient. 5. Patients of childbearing or child- fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study. 6. Site-specific inclusion criteria (any one or more of the following): Gynecologic Cancers: Endometrial cancer
    • Patients at a higher risk of recurrence (because of either grade, myometrial invasion, lymphatic vascular space invasion, tumor size, lymph node status, tumor extension, presence or absence of surgical staging)
    • Patients who have suffered a recurrence at the vaginal cuff
    • Patients who are unable to undergo surgery and must have treatment for an inoperable primary endometrial cancer. Cervical cancer
    • Patients who are unable to undergo surgery and must have treatment for an inoperable primary cervical cancer.
    • Patients with locally advanced cervical cancer in whom brachytherapy will be integrated as a boost to external beam radiation either in a palliative or curative setting (definitive or post-operative setting). Lung cancer
    • Patients with an endobronchial component causing symptoms
    • Patients who can not undergo resection because of poor lung function or distant lung metastasis Breast cancer
    • Infiltrating ductal carcinoma or DCIS, stage T0, T1, and T2 less than or equal to 3.0 cm, N0 and M0,
    • Patients benefiting from HDR as either as a boost or accelerated partial breast irradiation regimen. Prostate Cancer -Patients with localized prostate cancer (T1b-T3b) in whom brachytherapy will be integrated as a boost to external beam radiation or used as monotherapy for definitive management.

    Exclusion Criteria:

    • 1. Cognitively impaired patients who cannot give informed consent. 2. Patients currently receiving concurrent investigational chemotherapeutic agents. 3. Patients receiving concomitant chemotherapy administration in the 5 days preceding brachytherapy (except for gynecological cancer patients who may have received concurrent chemotherapy as a component of their treatment regimen) 4. Pregnant or breast-feeding females are excluded because of the potential mutagenic effects on a developing fetus or newborn. 5. Clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), which in the judgment of the Principal or Associate Investigator would compromise the patient s ability to tolerate this therapy or are likely to interfere with the study procedures or results. 6. Patients who are in the estimation of the PI, deemed unable or unlikely to adhere to protocol treatment. 7. Abnormal bleeding times or active anti-coagulation therapy.
    • platelets less than 100,000 per mm(3)
    • PT/PTT greater than 1.5 the upper normal limit (UNL) 8. Any patient or tumor/anatomical factors that may prevent brachytherapy apparatus from being properly and safely inserted and positioned and from radiation therapy being administered per ABS guidelines. 9. Patients whose malignancy has one or more of the following site-specific criteria disqualifying them from the study: 1. Breast cancer:
    • Patients inappropriate for standard breast conservation therapy (Multicentric disease, inability to achieve clear margins);
    • male patients with breast cancer
    • autoimmune disorders, including SLE, Scleroderma, etc
    • distant metastases; 2. Prostate cancer:
    • distant metastases
    • lymph node metastases

    Contact:

    • Theresa Cooley-Zgela, R.N.
    • (301) 451-8905

    Location:

    • National Institutes of Health Clinical Center, 9000 Rockville Pike
    • Bethesda Maryland 20892 United States

    View trial on ClinicalTrials.gov


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    Published March 5, 2017
  • A Pilot Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) to Detect High Grade Localized Prostate Cancer

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    A Pilot Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) to Detect High Grade Localized Prostate Cancer


    Condition: Prostate Cancer

    Intervention:

    • Drug: Pyruvate (13C)

    Purpose: This is a pilot study evaluating pre-surgical patients with histologically confirmed localized prostate cancer who receive infusion with hyperpolarized pyruvate (13C) injection and undergo metabolic MR imaging with endorectal coil within 12 weeks of subsequent radical prostatectomy.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02526368

    Sponsor: University of California, San Francisco

    Primary Outcome Measures:

    • Measure: Difference in peak lactate/pyruvate conversion with histologic grade of prostate cancer
    • Time Frame: Baseline
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Safety As measured by Adverse Events
    • Time Frame: Up to 2 years
    • Safety Issue:
    • Measure: Optimal cut-off value of lactate/pyruvate that accurately detects primary Gleason 4 component cancer.
    • Time Frame: Baseline
    • Safety Issue:

    Estimated Enrollment: 50

    Study Start Date: March 22, 2016

    Phase: Early Phase 1

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Biopsy-proven adenocarcinoma of the prostate. Biopsy may be performed outside of UCSF, if detailed results of sextant biopsy are available. A minimum of 20 patients out of a planned enrollment of 50 patients must have high-risk disease as defined by primary Gleason score of 4 or 5 on prior prostate biopsy.
    • Planned radical prostatectomy at University of California, San Francisco (UCSF) within 12 weeks following protocol MRI/magnetic resonance spectroscopic imaging (MRSI).
    • The subject is able and willing to comply with study procedures and provide signed and dated informed consent.
    • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
    • Adequate organ function, including absolute neutrophil count (ANC) ≥1500 cells/μL, hemoglobin ≥9.0 gm/dL, platelets ≥75,000 cells/μL, estimated creatinine clearance ≥50 mL/min (by the Cockcroft Gault equation), bilirubin <1.5x upper limit of normal (ULN) (unless Gilbert's is suspected), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <1.5x ULN.
    • For patients with partners of childbearing potential, willing to use adequate contraception for one month after undergoing hyperpolarized (HP) pyruvate infusion.

    Exclusion Criteria:

    • Patients who because of age less than 18 years old, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
    • Patients unwilling or unable to undergo MR imaging, including patients with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
    • Patients who cannot tolerate or have contra-indications to endorectal coil insertion; for example, patients with a prior abdominoperineal resection of the rectum or latex allergy.
    • Patients with contra-indications to injection of gadolinium contrast; for example patients with prior documented allergy or those with inadequate renal function.
    • Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging.
    • Cryosurgery, surgery for prostate cancer, prostatic or pelvic radiotherapy prior to study enrollment. No limit on number of prior prostate biopsies. Prior transurethral resection of the prostate (TURP) is not allowed.
    • Current or prior androgen deprivation therapy. A history of use of a 5-α reductase inhibitor is allowed, provided it was discontinued at least one month prior to study entry.
    • Poorly controlled hypertension, with blood pressure at study entry >160/100. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.
    • Congestive heart failure or New York Heart Association (NYHA) status ≥ 2.
    • A history of clinically significant EKG abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) within 6 months of study entry. Patients with rate-controlled atrial fibrillation/flutter will be allowed on study.

    Contact:

    • Rahul Aggarwal, MD
    • (415) 353-9278

    Location:

    • University of California, San Francisco
    • San Francisco California 94158 United States

    View trial on ClinicalTrials.gov


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    Published January 10, 2017
  • A Pilot Study to Evaluate the Reproducibility of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) and Its Ability to Reflect Treatment Effects in Patients With Prostate Cancer

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    A Pilot Study to Evaluate the Reproducibility of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) and Its Ability to Reflect Treatment Effects in Patients With Prostate Cancer


    Condition: Prostate Cancer

    Intervention:

    • Drug: Pyruvate

    Purpose: This is a pilot clinical study of hyperpolarized pyruvate (13C) injection that includes the acquisition of magnetic resonance (MR) data and will be performed in men with localized prostate cancer. Part 1: Five patients will be evaluated for reproducibility of 13C HP MR imaging measurements obtained 2-3 weeks apart with no interim treatment. Part 2: Five patients will be evaluated for the change in 13C HP MR imaging measurements after 2 months of ADT. 13C HP MR data will be acquired in two parts of the study (which can occur simultaneously): Part 1: Patients will undergo imaging at baseline and will be repeated two to three weeks later (with no intervention in the interim) to evaluate reproducibility. Part 2: Patients will undergo imaging at baseline, initiate androgen deprivation therapy, and undergo repeat imaging two months after initiation of ADT to evaluate the ability of the imaging to reflect a metabolic response to treatment. The change in pyruvate/lactate ratio and lactate levels will be measured and compared to baseline at these timepoints.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02450201

    Sponsor: University of California, San Francisco

    Primary Outcome Measures:

    • Measure: Difference in peak lactate/pyruvate ratio
    • Time Frame: Baseline and 2-3 weeks after 1st image
    • Safety Issue:
    • Measure: Difference in peak lactate/pyruvate ratio
    • Time Frame: Baseline and 2 months after 1st image
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Pyruvate area under the curve (AUC)
    • Time Frame: Baseline and 2-3 weeks after 1st image
    • Safety Issue:
    • Measure: Lactate area under the curve (AUC)
    • Time Frame: Baseline and 2-3 weeks after 1st image
    • Safety Issue:
    • Measure: Pyruvate area under the curve (AUC)
    • Time Frame: Baseline and 2 months after 1st image
    • Safety Issue:
    • Measure: Lactate area under the curve (AUC)
    • Time Frame: Baseline and 2 months after 1st image
    • Safety Issue:
    • Measure: Safety As measured by Adverse Events
    • Time Frame: Up to 2 years
    • Safety Issue:

    Estimated Enrollment: 10

    Study Start Date: June 2015

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • The subject has biopsy-proven adenocarcinoma of the prostate with intermediate to high risk disease by UCSF CAPRA scoring and possesses a Gleason 4 component to the tumor. Subjects will be enrolled either prior to radical prostatectomy (N=5) or prior to 2 months of androgen deprivation therapy (LHRH agonist +/- antiandrogen) followed by definitive radiation therapy as their primary treatment for prostate cancer (N=5).
    • The subject is able and willing to comply with study procedures and provide signed and dated informed consent.
    • At least 5 mm of tumor on biopsy (can have multiple cores to comprise 5 mm).
    • The subject has concordant MRI/1H MRSI findings from a MR staging exam at UCSF performed prior to the 13C MRSI exam performed in this study with IMP, or is willing to undergo MRI/1H MRSI in connection with the study exam.
    • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
    • Laboratory criteria for protocol entry:
    • Absolute neutrophil count (ANC) ≥1000 cells/µL
    • Hemoglobin ≥9.0 gm/dL
    • Platelets ≥75,000 cells/µL
    • Estimated creatinine clearance ≥50 mL/min
    • Total bilirubin ≤1.5x ULN (or if ≤4 gm/dL and direct bilirubin is WNL)
    • Aspartate aminotransferase (AST) ≤1.5x ULN
    • Alanine aminotransferase (ALT) ≤1.5x ULN
    • Willing to use contraception during and for 1 month after completion of the study.
    • For part 2 of the study: plans to initiate castrating therapy (with a GnRH antagonist, GnRH agonist, or orchiectomy). An antiandrogen may be started after initial imaging but can not be used prior to baseline imaging. An antiandrogen is allowed but not required.

    Exclusion Criteria:

    • The subject has received, or is scheduled to receive, another IMP from 1 month before to 1 month after inclusion in this study.
    • Current or prior androgen deprivation therapy; previous use of a 5-α reductase inhibitor is allowed, provided it was discontinued at least one month prior to study entry.
    • Poorly controlled hypertension, with blood pressure at study entry>160/100.
    • Contraindication for or inability to tolerate MRI examination.
    • Prostate biopsy within 12 weeks prior to study entry.
    • BMI of less than 18.5 or greater than 32. Subject body weight should be less than or equal to 100 kg owing to limitations in the amount of IMP available.
    • Congestive heart failure or New York Heart Association (NYHA) status≥2.
    • A history of clinically significant EKG abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) less than 1 year ago with ensuing unstable EKG.
    • Ongoing acute or chronic pulmonary bronchospastic disease, including a history of chronic obstructive pulmonary disease or asthma, with an exacerbation within the past year.

    Contact:

    • Rahul Aggarwal, MD
    • 415-353-9278

    Location:

    • University of California, San Francisco
    • San Francisco California 94158 United States

    View trial on ClinicalTrials.gov


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    Published January 10, 2017
  • A Prospective Single-Arm Phase I/II Study Using 11C-Choline PET Scans for Dose Escalated Hypofractionated Image Guided Inversely Planned Intensity Modulated External Beam Radiotherapy With Boost to PET Defined Dominant Intraprostatic Lesions and as a Pred

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    A Prospective Single-Arm Phase I/II Study Using 11C-Choline PET Scans for Dose Escalated Hypofractionated Image Guided Inversely Planned Intensity Modulated External Beam Radiotherapy With Boost to PET Defined Dominant Intraprostatic Lesions and as a Predictive Factor for Biochemical Disease-Free Survival in Patients With Localized Prostate Cancer


    Condition: Prostatic Neoplasms

    Intervention:

    • Radiation: 11C-Choline

    Purpose: Patients with localized prostate cancer are routinely treated with radiation therapy to the entire prostate gland. The investigators can identify where the cancer is concentrated in the prostate gland using a newer specialized imaging technique called 11C Choline PET (stands for choline positron emission tomography). This is different from the older type of PET scan that has been used in the past (called FDG PET) which has not been as accurate as the new PET scan for identifying where the cancer is in the prostate gland. It has also been shown that delivering higher doses of radiation to prostate cancer cells in the prostate have resulted in better cure rates in patients with prostate cancer. Therefore for goal number one the investigators want to give higher radiation dose to the prostate cancer cells. But the challenge has been that delivering higher doses of radiation to the prostate gland may also increase the chance of complications from the higher doses of radiation to the rectum, bladder and surrounding area. Therefore for goal number two the investigators want to minimize radiation dose to the rectum, bladder and surrounding area. 3-Tesla Magnetic Resonance Imaging (3T MRI) is a new kink of scan that will be used in this study to identify the urethra in the prostate so that the investigators can minimize the radiation dose to the urethra. The investigators believe the 3T MRI scan is able to point to the areas of cancer that may be able to predict how well the treatments may work, as well as which areas of the tumor appear to be responding to failing. In this study, the investigators will keep the dose of radiation to the rectum and bladder as low as possible while increasing radiation dose to parts of the prostate with more cancer cells. The investigators will compare the cure rates in this study with the cure rates of other patients receiving the standard treatment in which the same dose of radiation is delivered throughout the prostate gland. The investigators will also compare the rates of complications in this study with the rates of complications in patients receiving the standard treatment in which the same dose of radiation is delivered throughout the prostate gland.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02004418

    Sponsor: AHS Cancer Control Alberta

    Primary Outcome Measures:

    • Measure: Determine the toxicity profile of 11C-Choline administration in PET scans, therapeutic response and biochemical recurrence in patients treated with EBRT.
    • Time Frame: After 3 months
    • Safety Issue:
    • Measure: Determine the toxicity profile of 11C-Choline administration in PET scans, therapeutic response and biochemical recurrence in patients treated with EBRT
    • Time Frame: After 3 years
    • Safety Issue:
    • Measure: Determine the toxicity profile of 11C-Choline administration in PET scans, therapeutic response and biochemical recurrence in patients treated with EBRT
    • Time Frame: After 5 years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Intraprostatic lesion delineation capabilities of 11C-Choline in selected prostate cancer subjects for facilitation of Enhanced EBRT
    • Time Frame: 3 months
    • Safety Issue:
    • Measure: Intraprostatic lesion delineation capabilities of 11C-Choline in selected prostate cancer subjects for facilitation of Enhanced EBRT
    • Time Frame: 6 months
    • Safety Issue:

    Estimated Enrollment: 63

    Study Start Date: March 2014

    Phase: Phase 1/Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    1. Age ≥ 18 years
    2. Biopsy proven prostate cancer with an intermediate risk feature defined as
    3. Gleason score 7, PSA <20, T1-T2C or
    4. Gleason score 6, PSA 10-20, T1-T2C or
    5. Gleason Score 6 or 7, PSA <20, T2C
    6. Localized disease based on staging investigations including bone scan, CT abdomen and pelvis, and any other clinically indicated staging investigations
    7. Eligible for curative intent external beam radiotherapy
    8. Able and willing to follow instructions and comply with protocol
    9. Provide written informed consent prior to participation in the study
    10. Karnofsky Performance Scale Score 70-100

    Exclusion Criteria:

    1. Have had a 11C-Choline PET scan performed within 4 weeks after any biopsies of the prostate (due to concern that acute post biopsy intraprostatic changes may affect scan accuracy)
    2. BMI ≥ 30
    3. The presence of a hip prosthesis
    4. Bilirubin ≥ 20 µmol/L
    5. AST or ALT ≥ 5 times the upper limits of normal
    6. Serious medical conditions which may prevent a patient from tolerating therapy such as: congestive heart failure, unstable angina, unstable ventricular arrhythmia, uncontrolled psychiatric conditions, serious infections and/or uncontrolled diabetes.
    7. Metastatic disease
    8. Prostate cancer with only low risk features or any high risk feature with a PSA ≥20 or T3 disease
    9. A history of previous carcinoma except for basal cell carcinoma
    10. Age < 18 years
    11. Prior treatment with hormonal therapy
    12. AUA prostate symptom score > 20
    13. Crohn's disease or ulcerative colitis
    14. Patient is unable to comply adequately iwth bowel or bladder prep during CT simulation

    Contact:

    • John Amanie, MD
    • 780-432-8518

    Location:

    • Cross Cancer Institute
    • Edmonton Alberta T6G 1Z2 Canada

    View trial on ClinicalTrials.gov


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    Published January 10, 2017
  • A Prospective Stage 2S Clinical Trial Evaluating Hemi-Ablative Low Dose Rate (LDR) Brachytherapy for Localised Prostate Cancer

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    A Prospective Stage 2S Clinical Trial Evaluating Hemi-Ablative Low Dose Rate (LDR) Brachytherapy for Localised Prostate Cancer


    Condition: Prostatic Neoplasms, Cancer of the Prostate

    Intervention:

    • Radiation: Hemi gland focal LDR brachytherapy

    Purpose: This clinical study will evaluate side effects, quality of life and cancer control in patients with prostate cancer diagnosed on only one side of the prostate gland. The diagnosis of unilateral prostate cancer will be made by means of a prostate transperineal template biopsy (TTB) and multiparametric magnetic resonance imaging (mpMRI). Patients will be treated with low dose rate brachytherapy, using permanent iodine seed implants.Treatment will be limited to the side of the gland where the cancer has been diagnosed and is therefore called "focal" brachytherapy. Prostate brachytherapy is usually applied to the whole prostate gland. After whole gland prostate brachytherapy urinary, bowel and sexual function may be affected. In this focal approach, the side effects will be evaluated by means of patient questionnaires.These will be repeated at various intervals after treatment.The results will be compared to the same questionnaires responded by patients who have undergone whole gland brachytherapy.Therefore an assessment can be made whether focal therapy produces fewer side effects than whole gland brachytherapy.The observation period will last for two years after treatment. A biopsy and mpMRI will be repeated after two years to evaluate prostate cancer control.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02632669

    Sponsor: Royal Surrey County Hospital NHS Foundation Trust

    Primary Outcome Measures:

    • Measure: Treatment related Urinary toxicity (symptoms) as recorded by the IPSS questionnaire score.
    • Time Frame: 2 years
    • Safety Issue:
    • Measure: Treatment related Quality of Life (QoL) due to urinary symptoms as recorded by the Quality of Life (QoL) component of the IPSS questionnaire score.
    • Time Frame: 2 years
    • Safety Issue:
    • Measure: Treatment related bowel toxicity (symptoms) as recorded by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) questionnaire (30 PR 25) score.
    • Time Frame: 2 years
    • Safety Issue:
    • Measure: Treatment related adverse events on Erectile function as recorded by the International Index of Erectile Function 5 (IIEF 5) questionnaire score.
    • Time Frame: 2 years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: To evaluate tumor control of hemigland focal brachytherapy
    • Time Frame: 2 years
    • Safety Issue:

    Estimated Enrollment: 34

    Study Start Date: November 2013

    Eligibility:

    • Age: minimum N/A maximum N/A
    • Gender: Male

    Inclusion Criteria:

    1. TRUS biopsy (if taken): unilateral disease only
    2. Template biopsy (TTB): unilateral disease only, AND Gleason < 7 (either 3+4 or 4+3)
    3. mp-MRI results: Disease must present as unilateral (left or right) only
    4. Stage T1-T2bN0M0 disease, as determined by local guidelines *
    5. Serum PSA < 15
    6. Prostate volume < 50cc
    7. Eligible for brachytherapy as outlined in local guidelines*
    8. Life expectancy > 10 years

    Exclusion Criteria:

    • 1. Men who have had previous radiation therapy 2. Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer 3. Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging.
    • https://www.rcr.ac.uk/quality-assurance-practice-guidelines-transperineal-ldr-per manent-seed-brachytherapy-prostate-cancer

    Contact:

    • Ceri Jamieson
    • 44(0)1483406612

    Location:

    • Royal Surrey NHS Foundation Trust
    • Guildford GU2 7XX United Kingdom

    View trial on ClinicalTrials.gov


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    Published January 12, 2017
  • A Prospective Study Assessing the Predictive Value of TMPRSS2-ERG Gene Fusion and PTEN Deletion in High Risk Prostate Cancer Patients

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    A Prospective Study Assessing the Predictive Value of TMPRSS2-ERG Gene Fusion and PTEN Deletion in High Risk Prostate Cancer Patients


    Condition: Prostate Cancer

    Purpose: One of the biggest problems facing prostate cancer patients and their treating physicians is who needs to be treated and when. Common clinical and pathological parameters are useful (PSA, Gleason score, etc.) but do not clearly predict who will benefit from treatment and who will fail. Genetic markers for tumor aggressivity would be of greater value. The finding that the TMPRSS2-ERG gene fusion is associated with an increase risk of cancer progression is important. TMPRSS2 is controlled by androgen (testosterone) and ERG is part of a family of proteins which have a role in controlling cell growth, cell specialization and producing tumors. As a consequence of this gene fusion, production of the ERG protein increases in the presence of testosterone and could be key to the development of prostate cancer, resistance to treatment and poor outcome. The PTEN gene is known to have a role as a tumor suppressor. Its deletion is a contributing factor in the development of prostate cancers and poor outcome. The coexistence of the two markers could be associated with a higher risk of recurrence. To date there have been no studies regarding the presence of either of these two markers or their coexistence in high risk prostate cancer patients who, despite radiation therapy and androgen suppression, develop biochemical failure (their PSA levels rise once again). Patients participating in the PCS IV study (high risk prostate cancer treated with radiation therapy plus either 18 or 36 months of hormonal suppression) who have had biochemical failure or 3 years of follow-up post hormonal therapy will be approached. Tumor blocks from consenting patients will be collected and analyzed for the presence of the TMPRSS2-ERG gene fusion and the PTEN deletion at the Pathology Department of the Jewish General Hospital. Statistical analysis will be carried out to see whether either or both markers are present, whether they are associated with certain clinical and pathological high risk factors, and whether they can be used to predict which patients will fail treatment.

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT01350180

    Sponsor: Dr. Tamim Niazi

    Primary Outcome Measures:

    • Measure: number of patients with biochemical failure showing the TMPRSS2-ERG gene fusion and/or PTEN deletion
    • Time Frame: recruitment over 2 years
    • Safety Issue:

    Estimated Enrollment: 132

    Study Start Date: September 2010

    Eligibility:

    • Age: minimum N/A maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • patients with prostate cancer post radical radiation therapy and LHRH agonist treated in PCSIV clinical trial
    • biochemical failure (PSA nadir + 2) or minimum follow-up of 3 years post completion of hormonal therapy
    • high risk group 1. gleason score 8-10 2. PSA ≥ 20 ng/ml 3. T3 or T4

    Contact:

    • Sarah Riggio
    • 514-340-8222 Ext. 26771

    Locations:

    • Hôpital de Gatineau
    • Gatineau Quebec Canada
    • CHUM-Notre- Dame
    • Montreal Quebec Canada
    • Hôpital Maisonneuve-Rosemont
    • Montreal Quebec Canada
    • Jewish General Hospital
    • Montreal Quebec Canada
    • Montreal General Hospital
    • Montreal Quebec Canada
    • CHUS - Hôpital Fleurimont - Sherbrooke
    • Sherbrooke Quebec Canada
    • Centre Hospitalier régional de Trois-Rivières
    • Trois-Rivières Quebec Canada
    • CHUQ, L'Hôtel-Dieu de Québec
    • Quebec Canada

    View trial on ClinicalTrials.gov


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    Published June 29, 2017
  • A Randomised Feasibility Trial to Investigate the Timing of HDR Brachytherapy With EBRT in Intermediate and High Risk Localised Prostate CAncer Patients and Its Effects on Toxicity and Quality of Life

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    A Randomised Feasibility Trial to Investigate the Timing of HDR Brachytherapy With EBRT in Intermediate and High Risk Localised Prostate CAncer Patients and Its Effects on Toxicity and Quality of Life


    Condition: Prostate Cancer

    Intervention:

    • Radiation: Timing of HDR Brachytherapy to EBRT

    Purpose: TITLE Timing of HDR brachytherapy with EBRT in intermediate and high risk localised Prostate CAncer patients and its effects on Toxicity and Quality of life - randomised feasibility trial. SHORT TITLE THEPCA trial Protocol Version Number and Date Version 2.1, dated 16 DEC 2014 Study Duration Recruitment Duration 18-24 months Study Centre Southend University Hospital NHS Foundation Trust Objectives Assessment of acute toxicities: Genitourinary, gastrointestinal and sexual dysfunction at various time points. Number of Participants 50 participants Main Inclusion Criteria - Patient age >18 years - Histologically diagnosed Prostate cancer, stages T1b-T3bN0M0 - Any Gleason score - Any PSA level - Patient able to consent and fill in the questionnaires Exclusion Criteria - Previous TURP/HoLEP Laser Prostatectomy - Any Metastatic Disease - IPSS>20 - Pubic arch interference - Lithotomy position or anaesthesia not possible - Rectal fistula - Prior pelvic radiotherapy Statistical Methodology and Analysis Percentages of adverse events will be compared using Fisher's Exact Test. Toxicity score means will be compared using two-sample permutation t-tests, and PSA relapse-free survival will be estimated using Kaplan-Meier and compared using log-rank tests.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02618161

    Sponsor: Southend University Hospital Foundation NHS Trust

    Primary Outcome Measures:

    • Measure: Prospective assessment of genitourinary toxicities according to the treatment sequence of HDR Brachytherapy and EBRT
    • Time Frame: 12 months
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Biochemical response and survival
    • Time Frame: 12 months
    • Safety Issue:
    • Measure: Gastrointestinal toxicities according to the treatment sequence of HDR Brachytherapy and EBRT
    • Time Frame: 12 months
    • Safety Issue:
    • Measure: Radiotherapy Planning Challenges including Image Guided Radiotherapy
    • Time Frame: 12 months
    • Safety Issue:

    Estimated Enrollment: 52

    Study Start Date: September 2014

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Patient age >18 years
    • Histologically diagnosed Prostate cancer, stages T1b-T3bN0M0
    • Any Gleason score
    • Any PSA level
    • Patient able to consent and fill in the questionnaires

    Exclusion Criteria:

    • Previous TURP/HoLEP Laser Prostatectomy
    • Any Metastatic Disease
    • IPSS>20
    • Pubic arch interference
    • Lithotomy position
    • If Anaesthesia is not possible
    • Rectal fistula
    • Prior pelvic radiotherapy

    Contact:

    • Micheal Harrison
    • 08451964938

    Location:

    • Southend University Hospital NHS Foundation trust
    • Westcliff on sea Essex SS0 0RY United Kingdom

    View trial on ClinicalTrials.gov


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    Published January 22, 2017
  • A Randomized Clinical Trial Comparing the Efficacy of MRI Versus PSA for Prostate Cancer Screening: The MVP Study (MRI vs PSA)

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    A Randomized Clinical Trial Comparing the Efficacy of MRI Versus PSA for Prostate Cancer Screening: The MVP Study (MRI vs PSA)


    Condition: Prostate Cancer

    Intervention:

    • Device: Multi-parametric MRI
    • Other: PSA testing

    Purpose: In this open randomized controlled trial, we seek to study whether prostate cancer screening using multiparametric prostate magnetic resonance imaging (mpMRI) improves the detection rate of clinically-significant prostate cancer (defined as Gleason score ≥7 on prostate biopsy) compared with prostate cancer screening using prostate-specific antigen (PSA). The current paradigm of prostate cancer screening relies upon an initial PSA blood test, with subsequent investigations driven by the serum PSA level. This model has proven highly controversial due to the inability of PSA level to discern between indolent and aggressive forms of prostate cancer. As a result, numerous government-sponsored bodies have recommended against PSA screening. Evidence suggests that prostate cancer screening has led to an increased proportion of men being diagnosed with potentially curable prostate cancer. However, due to the inability of the PSA level to accurately distinguish patients with indolent and lethal forms of prostate cancer, it has led to a significant rate of over-diagnosis of indolent disease. Magnetic resonance imaging has been gaining an increasingly large role in the management of patients with clinically-localized prostate cancer including diagnosis in patients with abnormal PSA levels, monitoring of patients on active surveillance and staging prior to definitive interventions. MRI-based prostate cancer risk assessment has been shown to better distinguish between clinically-significant and insignificant tumors than PSA test. Therefore, a randomized controlled trial of MRI-based prostate cancer screening and PSA-based prostate cancer screening is warranted.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02799303

    Sponsor: Sunnybrook Health Sciences Centre

    Primary Outcome Measures:

    • Measure: Clinically-significant prostate cancer
    • Time Frame: Within 3 years of randomization
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Clinically-insignificant prostate cancer
    • Time Frame: Within 3 years of randomizations
    • Safety Issue:

    Estimated Enrollment: 1010

    Study Start Date: June 2016

    Phase: Phase 3

    Eligibility:

    • Age: minimum 50 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • age greater than or equal to 50 years old
    • life expectancy greater than or equal to 10 years, according to the clinical judgement of study investigators

    Exclusion Criteria:

    • history of previous prostate biopsy
    • PSA level measurement within 3 years of recruitment date
    • abnormal digital rectal examination of the prostate consistent with prostate cancer
    • history of prostate cancer in one or more first-degree relatives diagnosed at less than 50 years of age
    • lower urinary tract voiding symptoms (IPSS greater than or equal to 8)
    • prior or current use of 5-alpha reductase inhibitor medications (finasteride or dutasteride)
    • patient unable to communicate in English in order to give proper informed consent
    • claustrophobia or other medical indication which would preclude MRI
    • any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives

    Contact:

    • Robert Nam, MD
    • 416-480-5075

    Location:

    • Sunnybrook Health Sciences Centre
    • Toronto Ontario M4N3M5 Canada

    View trial on ClinicalTrials.gov


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    Published January 10, 2017
  • A Randomized Clinical Trial of Exercise vs. Usual Care Among Men Opting for Active Surveillance for Prostate Cancer

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    A Randomized Clinical Trial of Exercise vs. Usual Care Among Men Opting for Active Surveillance for Prostate Cancer


    Condition: Localized Prostate Cancer, Active Surveillance for Prostate Cancer

    Intervention:

    • Behavioral: Exercise

    Purpose: The AS RCT study is a randomized controlled trial of 16-weeks aerobic exercise (home-based walking) vs. usual care among 150 men with prostate cancer on active surveillance.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02435472

    Sponsor: University of California, San Francisco

    Primary Outcome Measures:

    • Measure: Genomic signature changes
    • Time Frame: At baseline and 16 weeks after start of intervention
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Messenger ribonucleic acid (mRNA) expression patterns in tumor and surrounding stromal (normal) tissue
    • Time Frame: At baseline and 16 weeks after start of intervention
    • Safety Issue:
    • Measure: Effect of aerobic training on general anxiety
    • Time Frame: At baseline and 16 weeks, 12 months and 24 months after start of intervention
    • Safety Issue:
    • Measure: Effect of aerobic training on specific prostate cancer anxiety
    • Time Frame: At baseline and 16 weeks, 12 months and 24 months after start of intervention
    • Safety Issue:
    • Measure: Adherence to active surveillance
    • Time Frame: At 12 and 24 months
    • Safety Issue:

    Estimated Enrollment: 150

    Study Start Date: May 2016

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Histologically-documented localized (stage
    • Patient has selected active surveillance as their management strategy for low- or low-intermediate risk prostate cancer as defined below;
    • ≥10 core prostate biopsy completed prior to randomization with at least 2mm of tumor and Gleason sum ≤6 with no pattern 4, or Gleason 3+4 in <34% of all cores;
    • Diagnostic or most recent PSA ≤15 ng/ml, or PSA density (PSAD) <0.15;
    • Low to Moderate fitness level at baseline (to be assessed via interview with the exercise Protocol Protocol staff and through CPET);
    • Medical clearance based on medical chart review and normal ECG (administered by a trained health professional) to undergo a symptom-limited cardiopulmonary exercise test and aerobic training intervention
    • Able to achieve and complete an acceptable cardiopulmonary exercise test defined as follows: achieving peak or plateau in oxygen consumption concurrent with increased power output; a respiratory exchange ratio ≥ 1.1 or volitional exhaustion- rating of perceived exertion >19
    • English-speaking A priori, we will allow men with concurrent benign prostatic hyperplasia (prostate volume >50g) to have a PSA between 10-15 ng/ml; and include men with low volume Gleason 3+4 disease. Also a priori, we will allow men with < than a 10 core biopsy at the discretion of the urologist if s/he classifies the patient as "low-risk" and a good candidate for active surveillance based on other favorable features (e.g., tumor molecular tests, prostate imaging, etc.). Sufficient tumor will be determined based on review of pathology notes and if needed, consultation with study pathologist. Current criteria for "sufficient" includes: >=1mm tumor and >=25% of available sample is tumor. Non-Randomized Observational Component Eligibility: Eligibility for the non-randomized observational component are:
    • Histologically-documented localized (stage
    • Undergoing or initiating active surveillance;
    • Medical clearance based on medical chart review and normal ECG (administered by a trained health professional) to undergo a symptom-limited cardiopulmonary exercise test and aerobic training intervention
    • English-speaking Exclusion Criteria:
    • Any prior or concurrent treatment for prostate cancer;
    • Use of finasteride or dutasteride within 3 weeks or 6 months, respectively, of study entry;57
    • Uncontrolled illness, physical disability, or other contraindication to aerobic exercise training including, but not limited to:
    • Acute myocardial Infarction (within 5 days of any planned study procedure);
    • Unstable angina;
    • Uncontrolled arrhythmia causing symptoms or hemodynamic compromise;
    • Recurrent syncope;
    • Active endocarditis;
    • Acute myocarditis or pericarditis;
    • Symptomatic severe aortic stenosis;
    • Uncontrolled heart failure;
    • Acute (within 3 months) pulmonary embolus or pulmonary infarction;
    • Thrombosis of lower extremities;
    • Suspected dissecting aneurysm;
    • Uncontrolled asthma;
    • Pulmonary edema;
    • Room air desaturation at rest ≤85%;
    • Respiratory failure;
    • Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (ie infection, renal failure, thyrotoxicosis); and
    • Mental impairment leading to inability to cooperate. Non-Randomized Observational Component:
    • The same

    Exclusion Criteria:

    • Any prior or concurrent treatment for prostate cancer;
    • Use of finasteride or dutasteride within 3 weeks or 6 months, respectively, of study entry;57
    • Uncontrolled illness, physical disability, or other contraindication to aerobic exercise training including, but not limited to:
    • Acute myocardial Infarction (within 5 days of any planned study procedure);
    • Unstable angina;
    • Uncontrolled arrhythmia causing symptoms or hemodynamic compromise;
    • Recurrent syncope;
    • Active endocarditis;
    • Acute myocarditis or pericarditis;
    • Symptomatic severe aortic stenosis;
    • Uncontrolled heart failure;
    • Acute (within 3 months) pulmonary embolus or pulmonary infarction;
    • Thrombosis of lower extremities;
    • Suspected dissecting aneurysm;
    • Uncontrolled asthma;
    • Pulmonary edema;
    • Room air desaturation at rest ≤85%;
    • Respiratory failure;
    • Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (ie infection, renal failure, thyrotoxicosis); and
    • Mental impairment leading to inability to cooperate. Non-Randomized Observational Component:
    • The same exclusion criteria apply as above.

    Contact:

    • June Chan
    • 877-827-3222

    Location:

    • University of CA San Francisco
    • San Francisco California 94158 United States

    View trial on ClinicalTrials.gov


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    Published July 23, 2019
  • A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer

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    A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer


    Condition: Prostate Cancer

    Intervention:

    • Biological: aglatimagene besadenovec
    • Biological: placebo
    • Drug: valacyclovir

    Purpose: The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in patients undergoing active surveillance for localized prostate cancer. ProstAtak® involves the use of aglatimagene besadenovec (AdV-tk) to kill tumor cells and stimulate a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak® has been well tolerated in previous trials in patients with prostate cancer and other tumor types. Biochemical, pathologic and immune responses have been demonstrated in newly diagnosed and recurrent prostate cancer. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak® or control arm at a 2:1 ratio. Both arms receive standard of care active surveillance evaluations.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02768363

    Sponsor: Advantagene, Inc.

    Primary Outcome Measures:

    • Measure: Proactive surveillance score
    • Time Frame: 12 months
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Biochemical response (change in PSA)
    • Time Frame: Assessed at each visit at 3, 6, 9 and 12 months
    • Safety Issue:
    • Measure: Patient reported Health Related Quality of Life
    • Time Frame: Assessed at each visit at 3, 6, 9 and 12 months
    • Safety Issue:
    • Measure: Time to radical treatment
    • Time Frame: 5 years
    • Safety Issue:
    • Measure: The safety profile will be characterized by collection of adverse event information and laboratory values during the treatment phase.
    • Time Frame: Assessed at each visit at 3, 6, 9 and 12 months
    • Safety Issue:

    Estimated Enrollment: 156

    Study Start Date: May 2016

    Phase: Phase 2/Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • include:
    • Histologically confirmed adenocarcinoma of the prostate
    • Patients choosing active surveillance
    • Patients meeting definition of NCCN low risk, intermediate risk OR patients having only one NCCN high-risk feature
    • NCCN Low Risk is defined as having all of the following: PSA < 10 ng/ml, Gleason ≤ 6, T1-T2a
    • NCCN Intermediate Risk is defined as having at least one of the following and no high risk features: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c
    • High Risk with a single high risk feature is defined as having only one of the following: PSA>20 ng/ml, Gleason score 8-10, or T3a
    • Excluded are those in the following risk groups: High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1
    • Patients must be planning and medically able to tolerate multiple transrectal ultrasound guided injections.
    • ECOG Performance status 0-2

    Exclusion Criteria:

    • include:
    • Active liver disease, including known cirrhosis or active hepatitis
    • Patients on systemic corticosteroids (>10 mg prednisone per day) or other immunosuppressive drugs
    • Known HIV+ patients
    • Regional lymph node involvement or distant metastases
    • Other current malignancy (except squamous or basal cell skin cancers)
    • Other serious co-morbid illness or compromised organ function that, in the opinion of the investigator, would interfere with treatment or follow up
    • Prior treatment for prostate cancer except TURP. If prior TURP, patients must be deemed able to receive prostate biopsy and multiple intra-prostatic injections by the investigator
    • Patients taking 5-alpha-reductase inhibitors (e.g. finasteride, dutasteride)
    • Patients who had or plan to use ADT or have history of an orchiectomy.
    • Patients who are planning to undergo radical treatment for prostate cancer within 12 months.
    • Known sensitivity or allergic reactions to acyclovir or valacyclovir

    Locations:

    • Foothills Urology
    • Golden Colorado 80401 United States
    • 21st Century Oncology
    • Fort Lauderdale Florida 33301 United States
    • Jesse Brown VA Medical Center
    • Chicago Illinois 60612 United States
    • The University of Chicago
    • Chicago Illinois 60637 United States
    • Southeast Louisiana Veterans Health Care System
    • New Orleans Louisiana 70119 United States
    • Walter Reed National Military Medical Center
    • Bethesda Maryland 20889 United States
    • University of Massachusetts Medical School
    • Worcester Massachusetts 01605 United States
    • Kansas City VA Medical Center
    • Kansas City Missouri 64128 United States
    • Sierra Nevada Health Care System VA
    • Reno Nevada 89502 United States
    • Urologic Research and Consulting LLC / New Jersey Urology
    • Englewood New Jersey 07631 United States
    • Hackensack University Medical Center
    • Hackensack New Jersey 07601 United States
    • Albany Stratton VA Medical Center
    • Albany New York 12208 United States
    • Advanced Radiation Centers of New York (Integrated Medical Professionals)
    • North Hills New York 11042 United States
    • Associated Medical Professionals of NY, PLLC
    • Syracuse New York 13210 United States
    • Southwest Urology, Clinical Research Solutions
    • Middleburg Heights Ohio 44130 United States
    • Oklahoma City VA Healthcare System
    • Oklahoma City Oklahoma 73104 United States
    • VA Portland Health Care System
    • Portland Oregon 97239 United States
    • Oregon Urology Insitute
    • Springfield Oregon 97477 United States
    • Lancaster Urology
    • Lancaster Pennsylvania 17604 United States
    • Allegheny Health Network-Triangle Urological Group
    • Pittsburgh Pennsylvania 15212 United States
    • Ralph H. Johnson Veterans Affairs Medical Center
    • Charleston South Carolina 29401 United States
    • San Antonio VA Healthcare System
    • San Antonio Texas 78229-4404 United States
    • Woodland Center
    • The Woodlands Texas 77384 United States
    • Texas Urology Specialists
    • Tomball Texas 77375 United States
    • Hunter Holmes McGuire VA Medical Center
    • Richmond Virginia 23249 United States
    • Salem VA Medical Center
    • Salem Virginia 24153 United States
    • Instituto Nacional de Ciencias Medicas y Nutrición, Salvador Subirán
    • Mexico City Mexico

    View trial on ClinicalTrials.gov


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    Published January 12, 2017
  • A Randomized Controlled Trial of ProstAtak® as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer

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    A Randomized Controlled Trial of ProstAtak® as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer


    Condition: Prostate Cancer

    Intervention:

    • Biological: ProstAtak®(AdV-tk) + valacyclovir
    • Biological: Placebo + valacyclovir

    Purpose: The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in combination with radiation therapy for patients with intermediate-high risk localized prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak has shown synergy with radiation without added toxicity and lower than expected recurrence rates in previous clinical trials. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak or control arm at a 2:1 ratio. Both arms receive standard external beam radiation therapy. Short-term androgen deprivation therapy may be given but is not required.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01436968

    Sponsor: Advantagene, Inc.

    Primary Outcome Measures:

    • Measure: Disease free survival defined as the time from randomization until the date of the first failure event will be compared for the ProstAtak® arm versus the placebo control arm. The analyses will be based on the intent to treat population.
    • Time Frame: Assessed at each visit every 6 months through year 5 until event occurs.
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Prostate cancer specific survival and overall survival will be compared for the ProstAtak® arm versus the placebo control arm.
    • Time Frame: Assessed at each visit every 6 months through year 5 after which long-term follow up of general health status will continue yearly.
    • Safety Issue:
    • Measure: PSA nadir will be compared for the ProstAtak® arm versus the placebo control arm.
    • Time Frame: Assessed at each visit every 6 months through year 5.
    • Safety Issue:
    • Measure: Patient reported Health Related Quality of Life outcomes will be collected using the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire. The change in QOL over time will be compared for the ProstAtak® arm versus the placebo control arm.
    • Time Frame: Assessed at baseline and at 3, 6, 12, 18 and 24 months after completion of radiation.
    • Safety Issue:
    • Measure: The safety profile will be characterized by collection of adverse event information and laboratory values during the treatment phase (until the completion of radiation). Data on late effects will be collected after radiation completion.
    • Time Frame: Assessed at each visit and continuously throughout the study.
    • Safety Issue:

    Estimated Enrollment: 711

    Study Start Date: September 2011

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • include:
    • Localized prostate cancer meeting the NCCN criteria of Intermediate Risk or patients having only one NCCN high-risk feature
    • NCCN Intermediate Risk is defined as having at least one of the following: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c
    • High Risk with a single high risk feature is defined as having only one of the following: PSA>20 ng/ml, Gleason score 8-10, or T3a
    • Excluded are those in the following risk groups: Low risk; High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1
    • Planning to undergo standard prostate-only external beam radiation therapy
    • ECOG Performance Status 0-2

    Exclusion Criteria:

    • include:
    • Liver disease, including known cirrhosis or active hepatitis
    • Patients on systemic corticosteroids (>10mg prednisone per day) or other immunosuppressive drugs
    • Known HIV+ patients
    • Regional lymph node involvement or distant metastases
    • Patients planning to receive whole pelvic irradiation
    • Prior treatment for prostate cancer, except TURP or ADT. For ADT, it may only be given for a maximum of 6 months
    • Patients who had or plan to have orchiectomy as the form of hormonal ablation
    • Known sensitivity or allergic reactions to acyclovir or valacyclovir

    Locations:

    • Arizona Oncology Services Foundation
    • Multiple Locations Arizona 85260 United States
    • Southern Arizona VA Health Care System
    • Tucson Arizona 85723 United States
    • Precision Radiation Oncology
    • Tustin California 92780 United States
    • Valley View Hospital
    • Glenwood Springs Colorado 81601 United States
    • Foothills Urology
    • Golden Colorado 80401 United States
    • Advanced Urology
    • Parker Colorado 80134 United States
    • Sibley Memorial Hospital
    • Washington District of Columbia 20016 United States
    • 21st Century Oncology
    • Fort Lauderdale Florida 33324 United States
    • 21st Century Oncology
    • Lakewood Ranch Florida 34202 United States
    • 21st Century Oncology
    • Naples Florida 34102 United States
    • 21st Century Oncology
    • Plantation Florida 33324 United States
    • Clinical Research Center of Florida
    • Pompano Beach Florida 33060 United States
    • James A. Haley Veteran's Hospital
    • Tampa Florida 33612 United States
    • Florida Urology Partners
    • Tampa Florida 33615 United States
    • Jesse Brown VA Medical Center
    • Chicago Illinois 60612 United States
    • The University of Chicago
    • Chicago Illinois 60637 United States
    • Silver Cross Hospital
    • New Lenox Illinois 60451 United States
    • Southeast Louisiana Veterans Health Care System
    • New Orleans Louisiana 70119 United States
    • VA Maryland Health Care System
    • Baltimore Maryland 21201 United States
    • The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer Center
    • Baltimore Maryland 21231 United States
    • Walter Reed National Military Medical Center
    • Bethesda Maryland 20889 United States
    • University of Massachusetts Medical School
    • Worcester Massachusetts 01605 United States
    • Kansas City VA Medical Center
    • Kansas City Missouri 64128 United States
    • Sheldon Freedman MD, Ltd.
    • Las Vegas Nevada 89144 United States
    • VA Sierra Nevada Health Care System
    • Reno Nevada 89502 United States
    • John Theurer Cancer Center at Hackensack University Medical Center
    • Hackensack New Jersey 07601 United States
    • Urologic Research and Consulting LLC / NJU Cancer Treatment Centers
    • Saddle Brook New Jersey 07663 United States
    • New Mexico Oncology Hematology Consultants (NMOHC)
    • Albuquerque New Mexico 87109 United States
    • University of New Mexico Cancer Center
    • Albuquerque New Mexico 87131 United States
    • James J. Peters VA Medical Center
    • Bronx New York 10468 United States
    • Advanced Radiation Centers of New York (Integrated Medical Professionals)
    • North Hills New York 11042 United States
    • Associated Medical Professionals of NY, PLLC
    • Syracuse New York 13210 United States
    • Southwest Urology, Clinical Research Solutions
    • Middleburg Heights Ohio 44130 United States
    • VA Portland Health Care System
    • Portland Oregon 97239 United States
    • Oregon Urology Institute
    • Springfield Oregon 97477 United States
    • Lancaster Urology
    • Lancaster Pennsylvania 17604 United States
    • Fox Chase Cancer Center
    • Philadelphia Pennsylvania 19111-2497 United States
    • Allegheny General Hospital, Allegheny Health Network
    • Pittsburgh Pennsylvania 15212 United States
    • Triangle Urological Group, Allegheny Health Network
    • Pittsburgh Pennsylvania 15212 United States
    • Wexford Health and Wellness Pavilion, Cancer Institute
    • Wexford Pennsylvania 15090 United States
    • Ralph H. Johnson Veterans Affairs Medical Center
    • Charleston South Carolina 29401 United States
    • VA North Texas Health Care System
    • Dallas Texas 75216 United States
    • Urology Clinics of North Texas
    • Dallas Texas 75231 United States
    • Dr. Irving Fishman's Office
    • Houston Texas 77030 United States
    • Houston Willowbrook Radiation Oncology
    • Houston Texas 77070 United States
    • Dr. Ned Stein's Office
    • Houston Texas 77074 United States
    • South Texas San Antonio VA Healthcare System
    • San Antonio Texas 78229-4404 United States
    • Texas Urology Specialists-The Woodlands
    • The Woodlands Texas 77385 United States
    • The Methodist Hospital - The Woodlands
    • The Woodlands Texas 77385 United States
    • Texas Urology Specialists
    • Tomball Texas 77375 United States
    • Salem VA Medical Center
    • Salem Virginia 24153 United States
    • MultiCare Regional Cancer Center - Gig Harbor
    • Gig Harbor Washington 98335 United States
    • MultiCare Regional Cancer Center - Tacoma
    • Tacoma Washington 98405 United States
    • VA Caribbean Healthcare System
    • San Juan 00921 Puerto Rico

    View trial on ClinicalTrials.gov


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    Published October 13, 2018
  • A Randomized Multicenter Phase III Trial Comparing Enzalutamide vs. a Combination of Ra223 and Enzalutamide in Asymptomatic or Mildly Symptomatic Castration Resistant Prostate Cancer Patients Metastatic to Bone.

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    A Randomized Multicenter Phase III Trial Comparing Enzalutamide vs. a Combination of Ra223 and Enzalutamide in Asymptomatic or Mildly Symptomatic Castration Resistant Prostate Cancer Patients Metastatic to Bone.


    Condition: Prostate Cancer

    Intervention:

    • Drug: Ra223
    • Drug: Enzalutamide

    Purpose: The objective of this randomized phase III open label trial is to assess if upfront combination of enzalutamide and Ra223 improves radiological progression-free survival compared to enzalutamide single agent in asymptomatic or mildly symptomatic castration resistant prostate cancer patients metastatic to bone.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02194842

    Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

    Primary Outcome Measures:

    • Measure: radiological progression-free survival
    • Time Frame: 46 months after first patient entry
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Overall survival
    • Time Frame: 63 months after first patient entry
    • Safety Issue:
    • Measure: prostate cancer specific survival
    • Time Frame: 63 months after first patient entry
    • Safety Issue:
    • Measure: First symptomatic skeletal event
    • Time Frame: 46 and 63 months after first patient entry
    • Safety Issue:
    • Measure: Time and incidence of first skeletal progression-free
    • Time Frame: 46 and 63 months after first patient entry
    • Safety Issue:
    • Measure: Time from entry to initiation of next systemic therapy
    • Time Frame: 46 and 63 months after first patient entry
    • Safety Issue:
    • Measure: Treatments elected after first disease progression
    • Time Frame: 46 and 63 months after first patient entry
    • Safety Issue:
    • Measure: Second progression-free survival in sequential regimen
    • Time Frame: 46 and 63 months after first patient entry
    • Safety Issue:
    • Measure: Pain
    • Time Frame: 46 and 63 months after first patient entry
    • Safety Issue:
    • Measure: Time to pain progression
    • Time Frame: 63 months after first patient entry
    • Safety Issue:
    • Measure: Occurence of adverse events
    • Time Frame: 63 months after first patient entry
    • Safety Issue:
    • Measure: Time to use of opioid analgesics
    • Time Frame: 63 months after first patient entry
    • Safety Issue:
    • Measure: Quality of Life
    • Time Frame: 46 and 63 months after first patient entry
    • Safety Issue:

    Estimated Enrollment: 560

    Study Start Date: October 2015

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Histologically confirmed diagnosis of prostate adenocarcinoma: 1. Asymptomatic or mildly symptomatic (defined as no opioids and Brief Pain Inventory score) 2. Metastatic to bone with ≥ 2 bone metastases (area of increase uptake on 99mTC BS (Technetium-99m bone scintigraphy) confirmed by standard X-Ray, Computed tomography (CT), or Magnetic resonance imaging (MRI)) with or without additional lymph node metastases. Visceral metastases are not allowed 3. Progressive Castration-resistant prostate cancer (CRPC) according to Prostate Cancer Working Group 2 (PCWG2) i.e. either of:
    • For patients who manifest disease progression solely as a rising Prostate-specific antigen (PSA) level. PCWG2 criteria require documentation of a sequence of rising PSA values at a minimum of 1-week intervals with the last value ≥ 2 ng/ml.
    • For patients with disease progression manifest in the bone, irrespective of progression by rising PSA, PCWG2 guidelines require appearance of 2 or more new lesions. Ambiguous results should be confirmed by other imaging modalities than bone scan and x-ray (e.g.: CT-scan or MRI).
    • For patients with disease progression manifest at nodal sites, irrespective of progression by rising PSA, PCWG2 requires progression according to RECIST 1.1.
    • Ongoing androgen deprivation therapy with LHRH (Human luteinizing hormone-releasing hormone) agonist or antagonist or bilateral orchiectomy
    • Patients must be at least 18 years old
    • WHO Performance status 0-1
    • Charlson score ≤ 3
    • Castrate serum levels of testosterone (< 50 ng/dL)
    • Biochemistry and hematology: 1. Adequate bone marrow function (absolute neutrophil count 1.5109/L; platelets 100 109/L, and hemoglobin > or = 10.0 g/dl.). 2. Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN), except for patient with Gilbert's disease 5.0 ULN 3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < or = 2.5 x ULN 4. Creatinine < or= 1.5 x ULN 5. Albumin > 25 g/L
    • Normal cardiac function according to local standard by 12-lead Electrocardiogram (ECG) (complete, standardized 12-lead recording)
    • Able to swallow the study drug and comply with study requirements
    • Prior or concomitant therapy 1. Prior docetaxel is permitted under the following conditions: start within 2 months of Androgen deprivation therapy (ADT) initiation, given for a maximum of 6 cycles and progression within 6 months of the last dose of docetaxel. 2. Previous treatment with bicalutamide, flutamide, prednisone, or dexamethasone is allowed if it was stopped at least 4 weeks prior to entry in the study 3. Patients taking bisphosphonates or denosumab are eligible if they have received a stable dose for 4 weeks or more prior to randomization. (These treatments may then be continued on study)
    • use of adequate birth control measures during the study treatment period and for at least 3 months after last dose of enzalutamide and 6 months after the last dose of Ra223.
    • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    • Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations

    Exclusion Criteria:

    • No known history of central nervous system metastases or leptomeningeal tumor spread.
    • No significant cardiovascular disease including: 1. Myocardial infarction within 6 months prior to screening 2. Uncontrolled angina within 3 months prior to screening 3. Congestive heart failure New York Heart Association (NYHA) class III or IV, or patients with history of congestive heart failure NYHA class III or IV in the past, unless a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is ≥ 45% 4. History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes) 5. History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place 6. Uncontrolled hypertension as indicated by a resting systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg at screening 7. Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mm Hg) at screening 8. Bradycardia as indicated by a heart rate of < 45 beats per minute on the screening ECG and on physical examination
    • patients having received docetaxel for CRPC are excluded.
    • No prior treatment with enzalutamide or Ra223
    • No prior and concomitant treatment with Cyp17 inhibitors (abiraterone, orteronel) and ketoconazole
    • No prior hemibody external radiotherapy. Patients who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count and platelets
    • No prior therapy with other radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188)
    • No involvement in another therapeutic trial involving an experimental drug
    • No anticancer therapy or treatment with another investigational agent within the last 4 weeks prior to randomization
    • No known hypersensitivity to compounds related to enzalutamide or Ra223
    • No prior history of malignancies other than prostate adenocarcinoma (except patients with basal cell, squamous cell carcinoma of the skin, in-situ carcinoma or low-grade superficial bladder cancer), or the patient has been free of malignancy for a period of 3 years prior to randomization date
    • No history of seizure, including any febrile seizure, loss of consciousness, or transient ischemic attack within 12 months of enrollment (registration date), or any condition that may pre-dispose to seizure (e.g., prior stroke, brain arterio-venous malformation, head trauma with loss of consciousness requiring hospitalization)
    • No major surgery within 4 weeks prior to treatment
    • No intake of narcotic analgesia for bone pain
    • No drug or alcohol abuse
    • No other serious illness or medical condition, such as but not limited to: 1. Any infection ≥ Grade 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4 2. No gastrointestinal disorder affecting absorption (e.g., gastrectomy or active peptic ulcer disease) 3. Crohn's disease or ulcerative colitis 4. Bone marrow dysplasia 5. Fecal incontinence 6. Life-threatening illness unrelated to cancer
    • No condition which, in the investigator's opinion, makes the patient unsuitable for trial participation

    Contact:

    • Evelien Nollet, PhD
    • +3227741571

    Locations:

    • Hopital Universitaire Brugmann
    • Brussels 1020 Belgium
    • Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme
    • Brussels 1070 Belgium
    • Cliniques Universitaires Saint-Luc
    • Brussels 1200 Belgium
    • Universitair Ziekenhuis Antwerpen
    • Edegem 2650 Belgium
    • AZ Groeninge Kortrijk
    • Kortrijk Belgium
    • CHU UCL Namur - Site Sainte-Elisabeth
    • Namur 5000 Belgium
    • AZ Turnhout
    • Turnhout Belgium
    • CHU Dinant Godinne - UCL Namur
    • Yvoir 5530 Belgium
    • Rigshospitalet
    • Copenhagen Denmark
    • Institut J. Paoli & I. Calmettes
    • Marseille 13273 France
    • Institut régional du Cancer Montpellier
    • Montpellier 34298 France
    • Gustave Roussy
    • Villejuif 94805 France
    • The Adelaide and Meath Hospital
    • Dublin Ireland
    • Ospedale B.Ramazzini
    • Carpi 41012 Italy
    • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
    • Meldola Italy
    • Istituto Europeo di Oncologia
    • Milano Italy
    • Medical University Of Gdansk
    • Gdańsk 80211 Poland
    • Maria Sklodowska-Curie Memorial Cancer Centre
    • Warsaw Poland
    • Hospital Del Mar
    • Barcelona 08003 Spain
    • Hospital De La Santa Creu I Sant Pau
    • Barcelona 08041 Spain
    • Hospital Universitario de Gran Canaria Doctor Negrin
    • Las Palmas de Gran Canaria Spain
    • Corporacio Sanitaria Parc Tauli
    • Sabadell Spain
    • Hospital Universitario de Salamanca
    • Salamanca 37007 Spain
    • Inselspital
    • Bern Switzerland
    • Kantonsspital St Gallen
    • St Gallen Switzerland
    • UniversitaetsSpital Zurich
    • Zurich 8091 Switzerland
    • The Christie NHS Foundation Trust
    • Manchester United Kingdom
    • Nottingham University Hospitals NHS Trust - City Hospital
    • Nottingham United Kingdom

    View trial on ClinicalTrials.gov


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    Published November 13, 2017
  • A Randomized Phase 2 Trial of 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With High-Risk Castrate Biochemically Relapsed Prostate Cancer After Local Therapy

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    A Randomized Phase 2 Trial of 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With High-Risk Castrate Biochemically Relapsed Prostate Cancer After Local Therapy


    Condition: Prostate Cancer

    Intervention:

    • Drug: 177Lu-J591
    • Drug: Ketoconazole
    • Drug: Hydrocortisone
    • Drug: 111In-J591

    Purpose: The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591 in combination with ketoconazole and hydrocortisone against prostate cancer.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT00859781

    Sponsor: Weill Medical College of Cornell University

    Primary Outcome Measures:

    • Measure: Proportion free of radiographically evident metastases at 18 months by CT and/or MRI scan of the abdomen and pelvis, chest x-ray or CT scan of the chest and bone scan
    • Time Frame: 18 months
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: PSA response rate
    • Time Frame: every 4 weeks
    • Safety Issue:

    Estimated Enrollment: 140

    Study Start Date: June 2009

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Histologically or cytologically confirmed adenocarcinoma of the prostate previously treated with surgery and/or radiotherapy.
    • Biochemical progression (rising PSA) after medical or surgical castration
    • High risk of systemic progression defined as: 1. Rising PSA as defined above and either: 2. Absolute PSA > 20 ng/mL AND/OR 3. PSA doubling time < 8 months
    • No evidence of local recurrence or distant metastases
    • Age >18 years.
    • Serum testosterone < 50 ng/ml
    • Patients capable of fathering children must agree to use an effective method of contraception for the duration of the trial.
    • Subjects on bisphosphonate therapy must be on a stable dose and must have started therapy > 4 weeks prior to protocol therapy.
    • Ability to understand and the willingness to sign a written informed consent document.

    Exclusion Criteria:

    • Use of red blood cell or platelet transfusions within 4 weeks of treatment
    • Use of hematopoietic growth factors within 4 weeks of treatment
    • Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment
    • Prior radiation therapy encompassing >25% of skeleton
    • Prior treatment with 89-Strontium or 153-Samarium containing compounds (e.g. Metastron®, Quadramet®)
    • Platelet count <150,000/mm3
    • Absolute neutrophil count (ANC) <2,000/mm3
    • Hematocrit <30 percent or Hemoglobin < 10 g/dL
    • Abnormal coagulation profile (PT or INR, PTT) > 1.3x ULN
    • Serum creatinine >2.5 mg/dL
    • AST (SGOT) >2x ULN
    • Bilirubin (total) >1.5x ULN
    • Serum calcium >11 mg/dL
    • Active serious infection
    • Active angina pectoris or NY Heart Association Class III-IV
    • Karnofsky Performance Status <70
    • Life expectancy <12 months
    • History of deep vein thrombosis and/or pulmonary embolus within 3 months of study entry
    • Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
    • Prior investigational therapy (medications or devices) within 6 weeks of treatment.
    • Prior use of ketoconazole for the purposes of prostate cancer therapy
    • Known history of HIV.
    • Currently active other malignancy other than non-melanoma skin cancer.

    Contact:

    • GUONC Research Team

    Locations:

    • University of Arizona Cancer Center
    • Tucson Arizona 85719 United States
    • Cedars Sinai
    • Los Angeles California 90048 United States
    • USC/Norris Comprehensive cancer center
    • Los Angeles California 90089 United States
    • Georgetown University Medical Center
    • Washington District of Columbia 20007 United States
    • University of Florida, Orlando Health
    • Orlando Florida 32806 United States
    • Emory University
    • Atlanta Georgia 30322 United States
    • Indiana University Melvin and Bren Simon Cancer Center
    • Indianapolis Indiana 46202 United States
    • University of Iowa Hospitals and Clinics
    • Iowa City Iowa 52242 United States
    • The University of Kansas Cancer Center
    • Westwood Kansas 66205 United States
    • North Shore Hematology Oncology Associates
    • East Setauket New York 11733 United States
    • Weill Cornell Medical College
    • New York New York 10021 United States
    • UPMC Cancer Center
    • Pittsburgh Pennsylvania 15232 United States
    • UPMC Hillman Cancer Center
    • Pittsburgh Pennsylvania 15232 United States
    • University of Utah
    • Salt Lake City Utah 84108 United States

    View trial on ClinicalTrials.gov


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    Published June 29, 2017

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