Localized Prostate Cancer Articles

Articles

  • [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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT00588185

    Sponsor: Memorial Sloan Kettering Cancer Center

    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

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT00464724

    Sponsor: M.D. Anderson Cancer Center

    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

    View trial on ClinicalTrials.gov


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    Published March 5, 2017
  • 68GA-PSMA FUSION PET/MRI FOR IMAGE-GUIDED PROSTATE BIOPSIES

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    68GA-PSMA FUSION PET/MRI FOR IMAGE-GUIDED PROSTATE BIOPSIES


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03689582

    Sponsor: University of Michigan Rogel Cancer Center

    Phase: Phase 2

    Eligibility:

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

    Inclusion Criteria:

    • Recent MRI of the prostate has resulted in at least one lesion suspected to represent prostate cancer (reported by the Radiologist as PI-RADS 3, 4 or 5 lesion)
    • Treating physician has already indicated a need for a prostate biopsy procedure.
    • Known Gleason 6 or 7 prostate cancer OR rising PSA with either a) no prior biopsy or b) single or multiple negative prior biopsies.

    Exclusion Criteria:

    • Prostate biopsy within 12 weeks before enrollment
    • Acute prostatitis within the last 6 months
    • Current non-urologic bacterial infection requiring active treatment with antibiotics
    • Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
    • Body weight greater than 350 lbs (158 Kg)
    • Inability or unwillingness to receive a prostate biopsy procedure
    • Unable to lie flat, still, or tolerate a PET/CT scan
    • Unable to provide own consent
    • Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 6 months prior to study participation, unstable and uncontrolled hypertension, acute renal failure of any intensity, chronic renal or hepatic disease, severe pulmonary disease).

    View trial on ClinicalTrials.gov


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    Published June 14, 2020
  • 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

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT00561444

    Sponsor: M.D. Anderson Cancer Center

    Phase:

    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.

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01342367

    Sponsor: University of Chicago

    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

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT00981578

    Sponsor: InSightec

    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

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01262664

    Sponsor: M.D. Anderson Cancer Center

    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.

    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

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT03193060

    Sponsor: AstraZeneca

    Phase:

    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.

    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

    Study Type: Observational [Patient Registry]

    Clinical Trials Identifier NCT 8-digits: NCT02546908

    Sponsor: Janssen Research & Development, LLC

    Phase:

    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

    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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    PROSPER: 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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02003924

    Sponsor: Pfizer

    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.

    View trial on ClinicalTrials.gov


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    Published March 29, 2018
  • 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 Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer


    Condition: Prostate Cancer Non-Metastatic, Castration-Resistant

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02200614

    Sponsor: Bayer

    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 (PSA) 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.

    View trial on ClinicalTrials.gov


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    Published March 29, 2018
  • 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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02111187

    Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    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.

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01391143

    Sponsor: MacroGenics

    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.

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01983709

    Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    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.

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02916537

    Sponsor: Cancer Targeted Technology

    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

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02064608

    Sponsor: Cambridge University Hospitals NHS Foundation Trust

    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

    View trial on ClinicalTrials.gov


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    Published January 12, 2017
  • A Phase 1/2 Study of Ibrutinib as Neoadjuvant Therapy in Patients With Localized Prostate Cancer

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    A Phase 2 Study of Ibrutinib as Neoadjuvant Therapy in Patients With Localized Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02643667

    Sponsor: Washington University School of Medicine

    Phase: Phase 1/Phase 2

    Eligibility:

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

    Inclusion Criteria:

    • 18 years of age or older
    • ECOG performance status 0 or 1
    • Histologically documented adenocarcinoma of the prostate
    • Patients must be suitable for and willing to undergo a radical prostatectomy at the completion of study therapy.
    • Adequate bone marrow function, defined as:
    • WBC >2,500 cells/mm3
    • ANC >1,500 cells/mm3
    • Hemoglobin >9 mg/dL
    • Platelet count >100,000 cells/mm3
    • Adequate renal function, defined as serum creatinine <2 mg/dL or CrCl >30 mL/min
    • Adequate liver function, defined as:
    • AST and ALT <2.5x institutional ULN
    • Serum bilirubin <1.5x institutional ULN
    • Adequate coagulation function, defined as normal PT/INR and PTT
    • Ability to understand and willingness to sign a written informed consent document
    • Available evaluable archival tumor tissue for correlative studies including assessment of immune infiltration and Btk expression is required. If archival tissue is unavailable, patients must be willing to undergo repeat prostate biopsy. Tissue is considered sufficient for correlative endpoint analyses if they are obtained from at least 2 prostate cores and consist of at least 15 unstained slides from the largest tumor volume and/or highest Gleason score. The availability of archival tissue or consent for repeat prostate biopsy is required for study eligibility; determination of tissue sufficiency is not required for study eligibility.
    • The effects of ibrutinib on the developing human fetus is unknown. Men treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of the study participation, and for 3 months after completion of treatment.

    Exclusion Criteria:

    • Patients with neuroendocrine or small cell features are not eligible.
    • Any evidence of metastatic disease. Pre-operative staging will be undertaken per urologic standard of care.
    • Any prior use of hormonal therapy, including:
    • GNRH agonists or GNRH antagonists (e.g., leuprorelin, degarelix)
    • Antiandrogens (e.g., bicalutamide, flutamide, nilutamide)
    • Novel androgen-directed therapies (e.g., abiraterone, enzalutamide)
    • Any estrogen containing compounds
    • 5-alpha reductase inhibitors (e.g., finasteride, dutasteride)
    • PC-SPES or PC-x products. Other herbal therapies or supplements will be considered by the Principle Investigator on a case by case basis based on their potential for hormonal or anti-cancer therapies.
    • Chemotherapy ≤ 21 days prior to first administration of study treatment and/or monoclonal antibody ≤ 6 weeks prior to first administration of study treatment
    • Prior radiation therapy for prostate cancer
    • Prior exposure to BTK inhibitors
    • Prior investigational therapy for prostate cancer
    • Patients may not receive any other concurrent investigational agents while on study.
    • Use of systemic steroid therapy within 28 days of study screening. Patients on inhaled or topical steroids are eligible.
    • Concurrent systemic immunosuppressive therapy within 21 days of the first dose of study drug.
    • Major surgery requiring the use of general anesthetic within 4 weeks of study enrollment
    • HIV, active hepatitis B (HBV) or active hepatitis C (HCV)
    • Patients with past HBV infection or resolved HBV infection, defined as the presence of hepatitis B core antibody (HBc Ab) and absence of hepatitis B surface antigen (HBsAg) are eligible. HBV DNA must be obtained in these patients prior to day 1 of ibrutinib therapy, but detection of HBV DNA in these patients will not exclude study participation.
    • Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
    • Inability to swallow capsules or presence of malabsorption syndromes, disease significantly affecting gastrointestinal function, history of resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete small obstruction.
    • Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Function Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to screening.
    • Uncontrolled concurrent illness, or any underlying medical condition, which in the Principal Investigator's opinion will make the administration of ibrutinib hazardous or obscure the interpretation of adverse events.
    • Recent infection requiring systemic treatment that was completed within 14 days prior to the first dose of study drug
    • Concurrent active malignancy other than non-melanoma skin cancers. Patients are considered to be free of active malignancy if they have completed curative therapy and have a <30% risk of relapse.
    • History of congenital bleeding diathesis.
    • Known bleeding disorders (e.g. von Willebrand's disease or hemophilia).
    • Concomitant use of anticoagulants including warfarin, other Vitamin K antagonists, and enoxaparin.
    • Subjects who received a strong or moderate cytochrome P450 (CYP) 3A4 inhibitor within 7 days prior to the first dose of ibrutinib or patients who require treatment with a strong or moderate cytochrome P450 (CYP) 3A inhibitor.
    • Vaccination with live, attenuated vaccines within 4 weeks of first dose of study drug.
    • Patients on anti-platelet agents including clopidogrel and glycoprotein IIb/IIIa inhibitors. Aspirin is allowed, but should be held before surgery according to standard practices.
    • Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child-Pugh classification
    • Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.
    • Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to CTCAE v 4.03 grade 0 or 1 or to the levels dictated in the

    Eligibility Criteria:

    1. with the exception of alopecia.

    View trial on ClinicalTrials.gov


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    Published December 31, 2015
  • 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

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT01418040

    Sponsor: Calvary Mater Newcastle, Australia

    Phase:

    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

    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, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02985957

    Sponsor: Bristol-Myers Squibb

    Phase: Phase 2

    Eligibility:

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

    Inclusion Criteria:

    • Evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria) on previous bone, CT and/or MRI scan.
    • 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)
    • Participants with skeletal system symptoms who are already on medications to strengthen bones are allowed if they were started ˃28 days before study treatment 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)
    • Prior whole pelvic radiotherapy, or radiotherapy to >30% of bone marrow. Bone-directed radiotherapy for palliation of painful bone metastases to pelvic region is allowed up to 14 days before treatment assignment. 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)
    • Prior whole pelvic radiotherapy, or radiotherapy to >30% of bone marrow. Bone-directed radiotherapy for palliation of painful bone metastases to pelvic region is allowed up to 14 days before treatment assignment. Other protocol defined inclusion/exclusion criteria could apply

    View trial on ClinicalTrials.gov


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    Published August 1, 2017
  • A Phase 3, Multi-Center, Open-Label Study to Assess the Diagnostic Performance and Clinical Impact of 18F-DCFPyL PET/CT Imaging Results in Men With Suspected Recurrence of Prostate Cancer

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    A Phase 3, Multi-Center, Open-Label Study to Assess the Diagnostic Performance and Clinical Impact of 18F-DCFPyL PET/CT Imaging Results in Men With Suspected Recurrence of Prostate Cancer


    Condition: Prostate Cancer, Prostate Adenocarcinoma, Prostate Cancer Recurrent, Prostate Cancer Metastatic

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03739684

    Sponsor: Progenics Pharmaceuticals, Inc.

    Phase: Phase 3

    Eligibility:

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

    Inclusion Criteria:

    • Male >/= 18 years of age
    • Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy
    • Suspected recurrence of prostate cancer based on rising PSA after definitive therapy on the basis of: 1. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (American Urological Association [AUA]); or 2. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (American Society for Therapeutic Radiology and Oncology [ASTRO]-Phoenix)
    • Negative or equivocal findings for prostate cancer on conventional imaging performed as part of standard of care workup within 60 days prior to Day 1
    • Life expectancy ≥6 months as determined by the investigator
    • Able and willing to provide informed consent and comply with protocol requirements

    Exclusion Criteria:

    • Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within five (5) physical half-lives prior to Day 1
    • Ongoing treatment with any systemic therapy (e.g. ADT, antiandrogen, GnRH, LHRH agonist or antagonist) for prostate cancer
    • Treatment with ADT in the past 3 months of Day 1
    • Receipt of investigational therapy for prostate cancer within 60 days of Day 1
    • Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or completing the study

    View trial on ClinicalTrials.gov


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    Published November 14, 2018
  • 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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02254746

    Sponsor: Centre Hospitalier Universitaire Vaudois

    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

    View trial on ClinicalTrials.gov


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    Published January 21, 2018
  • 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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03572478

    Sponsor: University of Chicago

    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.

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01488968

    Sponsor: AHS Cancer Control Alberta

    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.

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02628041

    Sponsor: CHU de Quebec-Universite Laval

    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.

    View trial on ClinicalTrials.gov


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    Published January 21, 2018
  • 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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02176902

    Sponsor: Jonsson Comprehensive Cancer Center

    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

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02559115

    Sponsor: Memorial Sloan Kettering Cancer Center

    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

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03069937

    Sponsor: Medical University of South Carolina

    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.

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02788773

    Sponsor: Canadian Cancer Trials Group

    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.

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01045226

    Sponsor: Abramson Cancer Center of the University of Pennsylvania

    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

    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

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT01352429

    Sponsor: Abramson Cancer Center of the University of Pennsylvania

    Phase:

    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.

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01858688

    Sponsor: Dana-Farber Cancer Institute

    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

    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: PSA Level Less Than or Equal to Fifteen, PSA Level Less Than Ten, Stage I Prostate Cancer AJCC v7, Stage II Prostate Cancer AJCC v7, Stage IIA Prostate Cancer AJCC v7, Stage IIB Prostate Cancer AJCC v7

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02095145

    Sponsor: National Cancer Institute (NCI)

    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-alpha-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

    View trial on ClinicalTrials.gov


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    Published October 13, 2018
  • 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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01230866

    Sponsor: Proton Collaborative Group

    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).

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02934685

    Sponsor: Beijing Hospital

    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

    View trial on ClinicalTrials.gov


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    Published January 21, 2018
  • 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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01809691

    Sponsor: Southwest Oncology Group

    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.

    View trial on ClinicalTrials.gov


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

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


    Condition: Prostate Cancer, Prostate Adenocarcinoma

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01411345

    Sponsor: University of Miami

    Phase: Phase 2/Phase 3

    Eligibility:

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

    Inclusion Criteria:

    1. 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.
    2. Patients with or without palpable abnormalities on digital rectal exam (DRE) are eligible.
    3. Minimum of 3 months since prostatectomy to allow for return of urinary continence and healing.
    4. Imaging detectable lesion or lesions in prostate bed or regional lymph node (LN). Each lesion should be at least 0.4 cc and a maximum of 6 cc and was obtained ≤ 3 months prior to protocol entry or enrollment.
    5. No evidence of metastatic (distant) disease (pelvic nodes are allowed up to common iliac).
    6. Negative bone scan if deemed necessary by treating physician obtained ≤ 4 months prior to protocol entry or enrollment.
    7. No previous pelvic radiotherapy.
    8. Serum total testosterone taken within 3 months prior to enrollment.
    9. 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 ≥ 3 years then the patient is eligible.
    10. Ability to understand and the willingness to sign a written informed consent document.
    11. Zubrod performance status <
    12. Patients must agree to fill out quality of life/psychosocial questionnaires.
    13. Age ≥ 35 and ≤ 85 years.

    Exclusion Criteria:

    1. 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).

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01411332

    Sponsor: University of Miami

    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.

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03016312

    Sponsor: Hoffmann-La Roche

    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

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03177460

    Sponsor: M.D. Anderson Cancer Center

    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)

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT00984321

    Sponsor: Memorial Sloan Kettering Cancer Center

    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

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT00924027

    Sponsor: National Cancer Institute (NCI)

    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

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02526368

    Sponsor: University of California, San Francisco

    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.

    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.

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02450201

    Sponsor: University of California, San Francisco

    Phase: Early Phase 1

    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.

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02004418

    Sponsor: AHS Cancer Control Alberta

    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

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02632669

    Sponsor: Royal Surrey County Hospital NHS Foundation Trust

    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

    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

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT01350180

    Sponsor: Dr. Tamim Niazi

    Phase:

    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

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02618161

    Sponsor: Southend University Hospital Foundation NHS Trust

    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

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02799303

    Sponsor: Sunnybrook Health Sciences Centre

    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

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02435472

    Sponsor: University of California, San Francisco

    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.

    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

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02768363

    Sponsor: Advantagene, Inc.

    Phase: Phase 2

    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

    View trial on ClinicalTrials.gov


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    Published January 12, 2017

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