Localized Prostate Cancer Articles

Articles

  • A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

    {{header-clinical-trials-navigation}}

    A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy


    Condition: Prostatic Neoplasms

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03767244

    Sponsor: Janssen Research & Development, LLC

    Phase: Phase 3

    Eligibility:

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

    Inclusion Criteria:

    • Histologically confirmed adenocarcinoma of the prostate
    • High-risk disease defined by a total Gleason Sum Score greater than equal to (>=) 4+3 (=Grade Groups [GG] 3 5) and >=1 of the following 4 criteria: a) Any combination of Gleason Score 4+3 (= 3) and Gleason Score 8 (4+4 or 5+3) in >= 6 systematic cores (with >=1 core Gleason Score 8 [4+4 or 5+3] included); b) Any combination of Gleason Score 4+3 (=GG 3) and Gleason Score 8 (4+4 or 5+3) in >=3 systematic cores and Prostate-specific antigen (PSA) >=20 ng/mL (with >= 1 core Gleason Score 8 [4+4 or 5+3] included); c) Gleason Score >=9 (=GG 5) in at least 1 systematic or targeted core; d) At least 2 systematic or targeted cores with continuous Gleason Score >=8 (=GG 4), each with > 80 percent (%) involvement
    • Candidate for radical prostatectomy with pelvic lymph node dissection as per the investigator
    • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
    • Contraceptive use by male participants (and female partners of male participants enrolled in the study who are of childbearing potential or are pregnant) should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
    • Able to receive androgen deprivation therapy (ADT) for at least 13 months

    Exclusion Criteria:

    • Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Participants are considered eligible only if the central radiological review confirms clinical stage M0
    • (a) Prior treatment with androgen receptor antagonists; (b) Treatment with gonadotropin-releasing hormone analog (GnRHa) prior to informed consent form (ICF) signature
    • History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer
    • Use of any investigational agent less than or equals to (<=)4 weeks prior to randomization or any therapeutic procedure for prostate cancer at any time
    • Major surgery <=4 weeks prior to randomization
    • Any of the following within 12 months prior to first dose of study drug: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (example, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published December 6, 2018
  • A Study Into the Pharmacodynamic Biomarker Effects of Olaparib (a PARP Inhibitor) ± Degarelix (a GnRH Antagonist) Given Prior to Radical Prostatectomy

    {{header-clinical-trials-navigation}}

    A Study Into the Pharmacodynamic Biomarker Effects of Olaparib (a PARP Inhibitor) ± Degarelix (a GnRH Antagonist) Given Prior to Radical Prostatectomy


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02324998

    Sponsor: Cambridge University Hospitals NHS Foundation Trust

    Phase: Phase 1

    Eligibility:

    • Age: minimum 18 Years maximum 73 Years
    • Gender: Male

    Inclusion Criteria:

    • To be included in the trial the patient must:
    • Have given written informed consent to participate*
    • Men aged 18 years or over
    • Patients suitable for radical prostatectomy
    • ECOG performance status of 0 or 1
    • Access to archived diagnostic tissue or consent to undergo repeat biopsy, if necessary
    • Diagnosis of High risk or Intermediate risk prostate cancer, defined as:
    • High risk disease: one or more of stage T2c
    • 3a, or PSA level >20ng/mL, or Gleason score ≥ 8
    • Intermediate risk disease: two or more of: Stage T2 (any), PSA > 10, Gleason of ≥ 7
    • Adequate bone marrow reserve and organ function (measured within 28 days prior to planned first olaparib administration) as demonstrated by the following values:
    • Absolute neutrophil count ≥ 1.8 x 109/L
    • Haemoglobin ≥ 117g/L
    • Platelet count ≥ 135 x 109/L
    • WBC ≥ 3.6 x 109/L
    • Peripheral blood smear with no features of MDS/AML
    • Adequate hepatic function:
    • Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 1.5 times the upper limit of normal (ULN) AND
    • Total bilirubin ≤ 1.5 times the ULN unless in the presence of Gilbert's syndrome with an elevated indirect fraction
    • Adequate renal function:
    • Serum creatinine ≤ 1.5 times the ULN concurrent with creatinine clearance ≥ 50mL/min (calculated by Cockcroft and Gault equation)
    • Willing to use two highly effective forms of contraception (see section 11.8) throughout their participation in the trial and for three months after their last dose of olaparib. Patients must refrain from donating sperm from the start of dosing up until sixteen weeks after discontinuing trial treatment
    • Normal chest radiograph (CXR) and oxygen saturations
    • Patients who are currently/have recently been involved in non-drug-based research are eligible to participate
    • If the patient does not consent to participate in the optional genetic research (ctDNA studies on blood) or to optional additional biopsies there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the trial.

    Exclusion Criteria:

    • The presence of any of the following will preclude patient inclusion:
    • Contraindication to olaparib or degarelix
    • History of hypersensitivity to active or inactive excipients of olaparib
    • Patients with known hypersensitivity to the degarelix active substance or mannitol must not receive degarelix.
    • Current refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of olaparib
    • As judged by the Investigator, any patient considered a poor medical risk due to a serious uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection including but not limited to:
    • Uncontrolled ventricular arrhythmia
    • Recent myocardial infarction (within three months)
    • Unstable spinal cord compression
    • Superior vena cava syndrome
    • Extensive bilateral lung disease on High Resolution Computed Tomography (HRCT)
    • History of pneumonitis
    • Active infection including hepatitis B, hepatitis C and Human Immunodeficiency Virus. Screening for chronic conditions is not required.
    • Major surgery within 4 weeks prior to entry into the trial (excluding placement of vascular access). Patients must have recovered from side effects of any major surgery. Minor surgery (not including the diagnostic prostate biopsy) within 2 weeks prior to entry into the trial.
    • Patients who have received (within last 3 months of trial entry) an investigational drug within a clinical trial will not be eligible to participate.
    • Concomitant use of known potent CYP3A4 inhibitors and inducers. See section 10.4.1.1 for list and consider wash out periods.
    • Blood transfusions within 1 month prior to the trial start
    • ECG with mean resting QTc of ≥ 470ms (Fridericia; as per local reading) on two or more time points within a 24 hour period or family history of long QT syndrome
    • Concomitant medications known to prolong the QT interval (see Appendix 1) or with factors that increase the risk of QTc prolongation or risk of arrhythmic events (such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age), History of Torsades de pointes.
    • Judgement by the Investigator that the patient is unsuitable to participate in the trial and the patient is unlikely to comply with trial procedures, restrictions and requirements
    • Patients with MDS or AML, or other previous malignancy except patients that have undergone treatment with curative intent for prior malignancy with no evidence of active prior malignancy are eligible.
    • With the exception of alopecia, any unresolved toxicities from prior chemotherapy should be no greater than CTCAE (version 4.03) Grade 1 at the time of starting olaparib treatment.
    • Patients with a desire to have children following the trial will not be recruited

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published January 30, 2017
  • A Trial to Assess Robot-assisted Surgery and Laparoscopy-assisted Surgery in Patients With Mid or Low Rectal Cancer

    {{header-clinical-trials-navigation}}

    A Trial to Assess Robot-assisted Surgery and Laparoscopy-assisted Surgery in Patients With Mid or Low Rectal Cancer


    Condition: Rectal Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01423214

    Sponsor: Kyungpook National University Hospital

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum 80 Years
    • Gender: All

    Inclusion Criteria:

    • Eligibility rule of enrollment
    • Rectal adenocarcinoma that were 10 cm or less from the anal verge
    • at least 18 years old & at most 80 years old
    • Clinically diagnosed cT3N0-2 disease
    • Clinical diagnosis of carcinoma involving a single rectal segment
    • Patients with adequate hepatic, renal, and bone marrow function, and a left ventricular ejection fraction of 55% or higher measured by echocardiography

    Exclusion Criteria:

    • The presence of metastasis to the liver, lung, brain, bone, abdominal aortic lymph node, lateral pelvic wall lymph node and inguinal lymph node
    • A past history of the cancer occurring in other body areas than the rectal cancer (except for a past history of the radical resection due to skin cancer)
    • Severe cardiac diseases or failure
    • Severe pulmonary diseases or dysfunction
    • The presence of psychiatric diseases
    • The concurrent presence of other severe medical diseases
    • An ineligibility to participate in the clinical study based on the judgment of investigators from a legal perspective

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2017
  • Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer

    {{header-clinical-trials-navigation}}

    Active Surveillance of 2 Groups of Patients With Localized Prostate Cancer


    Condition: Adenocarcinoma of the Prostate

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01795365

    Sponsor: Centre Hospitalier Universitaire Vaudois

    Eligibility:

    • Age: minimum 18 Years maximum 75 Years
    • Gender: Male

    Inclusion Criteria:

    • Localized adenocarcinoma of the prostate with a Gleason score of 3+3 (group I patients) or 3+4 (group II patients)
    • Percentage of tumor biopsy invasion <50% and/or with a size of maximum 8 mm
    • With a number of positive tumor biopsies ≤3 (group I patients) or ≤ 5 (group II patients)
    • TNM stage T1-2a N0 M0 (group I patients); TNM stage T1-2c N0 M0 (group II patients)
    • PSA level at diagnosis < 10 ng/ml for group I patients; < 15 ng/ml for group II patients
    • Tumor volume negative (group I patients); positive (group II patients)
    • Absence of extra-capsular extension
    • Life expectancy > 10 years
    • Signed informed consent
    • Patient has elected active surveillance as preferred management plan for the prostate cancer

    Exclusion Criteria:

    • Previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery or chemotherapy)
    • Patients with hypogonadism

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2017
  • Active Surveillance With or Without a 6 Months Apalutamide Treatment in Low Risk Prostate Cancer: A Phase II Randomized Multicenter Trial

    {{header-clinical-trials-navigation}}

    Active Surveillance With or Without a 6 Months Apalutamide Treatment in Low Risk Prostate Cancer: A Phase II Randomized Multicenter Trial


    Condition: Low Risk Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03088124

    Sponsor: Institut Paoli-Calmettes

    Phase: Phase 2

    Eligibility:

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

    Inclusion Criteria:

    • 1. Out-patient aged ≥ 18 years old 2. With life expectancy of more than 5 years 3. With ECOG performance status = 0 or 1 4. Having read, understood, signed and dated the informed consent, 5. With a Localized prostate cancer diagnozes within less than 7 months and defined by:
    • Clinical Stage: T1c or T2a
    • Sampled biopsy with less of 3 positive cores and tumor length < 3 mm per core (<7 mm for targeted cores)
    • Gleason score < 7 (3+4 for patients >70years if small volume tumor)
    • PSA levels ≤ 10 ng/ml or PSA density <0.2ng/ml/ml 6. Clinical laboratory values at screening: 1. Hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization 2. Platelet count ≥100,000 x 109/µL independent of transfusion and/or growth factors within 3 months prior to randomization 3. Serum albumin ≥3.0 g/dL 4. Serum creatinine <2.0 × upper limit of normal (ULN) 5. Serum potassium ≥3.5 mmol/L 6. Serum total bilirubin ≤1.5 × ULN (Note: In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject may be eligible) 7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN 7. Medications known to lower the seizure threshold (see list in appendix 2) must be discontinued or substituted at least 4 weeks prior to study entry. 8. Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug. 9. Having accepted the principle of active surveillance 10. Who is willing to participate to the study for a minimum period of 36 months 11. Able to swallow the study drug and comply with study requirements 12. Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen.

    Exclusion Criteria:

    1. Prior treatment for prostate cancer with surgery or radiotherapy or including 5-alpha reductase inhibitor (finasteride or dutasteride) and antiandrogen
    2. Absolute neutrophil count < 1,500/μL,
    3. Seizure or known condition that may pre-dispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to randomization, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
    4. Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization
    5. Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
    6. Uncontrolled hypertension (SBP≥160 mmHg or DBP≥90 mmHg). Patients with a history of uncontrolled hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
    7. Gastrointestinal disorder affecting absorption
    8. Active infection (eg, human immunodeficiency virus [HIV] or viral hepatitis) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
    9. Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures
    10. Mental deficiency or any other reason that may hinder the understanding or the strict application of the Protocol
    11. Patient placed under judicial protection, tutorship, or curatorship
    12. Patient unlikely to attend control visits
    13. Patient currently enrolled in an investigational study or having participated to another investigational study within the past 3 months

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2017
  • Adoptive Transfer of Autologous T Cells Targeted to Prostate Specific Membrane Antigen (PSMA) for the Treatment of Castrate Metastatic Prostate Cancer (CMPC)

    {{header-clinical-trials-navigation}}

    Adoptive Transfer of Autologous T Cells Targeted to Prostate Specific Membrane Antigen (PSMA) for the Treatment of Castrate Metastatic Prostate Cancer (CMPC)


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01140373

    Sponsor: Memorial Sloan Kettering Cancer Center

    Phase: Phase 1

    Eligibility:

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

    Inclusion Criteria:

    • Male, over 18 years of age
    • Karnofsky Performance Scale (KPS) greater or = to 70%
    • Histologic confirmation of prostate cancer at Memorial Sloan-Kettering Cancer Center (MSKCC)
    • A diagnosis of progressive castrate metastatic prostate cancer defined as one or more of the following three criteria:
    • Soft tissue progression defined by RECIST 1.0
    • Bone disease progression defined by PCWG2 with two or more new lesions on bone scan
    • Post-hormonal therapy rising PSA values from a hormone therapy nadir on greater or = to 3 successive determinations at least two weeks apart, where the increase above the nadir is the greater of greater or = to 2.0 ng/mL or a greater or = to 10% change (Subjects with a rise in PSA but no evidence of metastases at any time by imaging studies will NOT be eligible.)
    • For subjects who have discontinued anti-androgen therapy, PSA rise as defined above must be documented:
    • Within two weeks after discontinuation if used following surgical or medical castration (second line therapy)
    • After four weeks discontinuation if used as first line therapy.
    • Evidence of metastatic disease in bone on bone scan, CT scan, and/or by MRI atany time following the initial diagnosis of prostate cancer.
    • Castrate level of serum testosterone (<50 ng/mL) achieved by prior hormonal therapy consisting of either a) orchiectomy or b) luteinizing hormone-releasing hormone (LHRH) agonists with or without an anti-androgen
    • Castrate level of serum testosterone (<50 ng/mL) achieved by prior hormonal therapy consisting of either a) orchiectomy or b) luteinizing hormone-releasing hormone (LHRH) agonists with or without an anti-androgen
    • Lab requirements (Hematology):
    • White blood count (WBC) ≥3,000/mm3
    • Absolute neutrophil count ≥1,500/mm3
    • Platelet ≥100,000/ mm3
    • Hemoglobin ≥10 gm/d Lab requirements (Serum Chemistry):
    • Bilirubin <1.5 X ULN (the upper limit of normal) (Subjects with confirmed Gilbert's Disease as the cause of their elevated bilirubin are to be permitted.)
    • Serum alanine aminotransferase/serum aspartate aminotransferase (ALT/AST) < 2.5 X ULN (the upper limit of normal)
    • Serum creatinine <1.5 X ULN(the upper limit of normal)
    • Negative screen for Human Immunodeficiency virus (HIV), Hepatitis B virus (HBV) antigen, and Hepatitis C virus (HCV). If testing was done within the past three months, there is no need to repeat testing, as long as documentation of results is provided to the study site. Subjects must receive counseling and sign a separate informed consent for HIV testing.
    • Subjects and their partners of reproductive potential must agree to use an effective form of contraception during the period of drug administration and for four weeks following the completion of the last administration of the study drug. An effective form of contraception is defined as oral contraceptives plus one form of barrier method or double barrier methods (condom with spermicide or condom with diaphragm).
    • Subjects must be able to understand the potential risks and benefits of the study, and be able to read and give written informed consent.

    Exclusion Criteria:

    • History of non-prostate, primary, malignant cancer, except for non-melanoma skin cancer within previous five years
    • History of splenectomy
    • Autoimmune- or Ab-mediated disease including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, temporal arteritis, and thyroiditis
    • Clinically significant cardiac disease (New York Heart Association Class III/IV) or severe debilitating pulmonary disease
    • Radiation therapy within four weeks prior to start of study treatment (Day -1)
    • Patients may not have received more than one prior chemotherapy
    • The following medications within four weeks prior to start of study treatment (Week 1): systemically administered radiopharmaceuticals such as bone seeking isotopes (e.g., samarium-153 Lexidronam); hematopoietic growth factors other than erythropoietin; medroxyprogesterone as an appetite stimulant; or alternative medicine treatments for prostate cancer, including Prostasol (formerly: PC-Plus), saw palmetto, or Zyflamend®
    • Active central nervous system (CNS) or symptomatic epidural metastatic disease
    • An infection requiring antibiotic treatment within seven days of starting study treatment (Day -1)
    • A requirement for daily systemic corticosteroids for any reason; or other immunosuppressive or immunomodulatory agents. Topical, nasal or physiologic corticosteroids are to be permitted.
    • Administration of live attenuated vaccines within eight weeks of start of study treatment (Day -1) and throughout the study
    • Administration of subunit or killed vaccines, such as influenza or pneumococcal vaccine, within two weeks prior to study treatment (Day-1) and throughout the study; EXCEPTION
    • Vaccination for influenza is permitted between Week 12 through Week 16 and after Week 20.
    • Positive stool guaiac, excluding hemorrhoids or documented radiation-induced proctitis if test is performed at the discretion of the treating physician (stool guaiac test is not required to screen for eligibility).
    • Any other medical condition that in the opinion of the Investigator may interfere with a subject's participation in, or compliance with, the study
    • Participation in a therapeutic research study or receipt of an investigational drug within 4 weeks leukapheresis.
    • Allergy to ganciclovir or acyclovir.

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2017
  • An Open Label, Randomized Phase 2 Trial of Prostvac and Ipilimumab as Monotherapy or in Combination for Men With Localized Prostate Cancer Undergoing Radical Prostatectomy

    {{header-clinical-trials-navigation}}

    An Open Label, Randomized Phase 2 Trial of Prostvac and Ipilimumab as Monotherapy or in Combination for Men With Localized Prostate Cancer Undergoing Radical Prostatectomy


    Condition: Prostatic Neoplasms

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02506114

    Sponsor: University of California, San Francisco

    Phase: Phase 2

    Eligibility:

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

    Inclusion Criteria:

    • For a subject to be eligible for participation in this study, all of the following criteria must be satisfied: 1. Patients must have histologically confirmed adenocarcinoma of the prostate without previous therapy for PC.
    • Treatment-naïve AND
    • Undergoing RP as initial, locally definitive therapy for PC AND
    • Eligible for RP in a 3 month timeframe AND
    • Consentable for RP 2. Subject's archival prostate biopsy specimen is available, and subject consents to provide tissue for study endpoint analysis. The prostate biopsy slides or blocks must be available prior to starting any study treatment. 3. Age ≥ 18 years 4. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Subject has adequate organ function, defined as:
    • White blood cell (WBC) count ≥ 3,000/microliter (mcL)
    • Absolute neutrophil count (ANC) ≥ 1,500/mcL
    • Platelet count ≥ 100,000/mcL
    • Hemoglobin (Hgb) ≥ 10.0 g/dL
    • Creatinine ≤ 1.5x institutional upper limit of normal (ULN)
    • Total bilirubin ≤ 1.5 x institutional ULN
    • Alanine aminotransferase (ALT) ≤ 1.5 x institutional ULN
    • Aspartate aminotransferase (AST) ≤ 1.5 x institutional ULN
    • Prothrombin time (PT) /International Normalized Ratio (INR), partial thromboplastin time (PTT) within institutional ULN 6. No known history of human immunodeficiency virus (HIV) 1 and 2, human T-cell lymphotropic virus (HTLV)-I/II, and Hepatitis B and C. 7. Ability to understand a written informed consent document, and the willingness to sign it. 8. Because of the unknown potential risk to a gamete and/or developing embryo from these investigational therapies, subjects must agree to use adequate contraception (i.e. barrier method) for the duration of study participation, and for three months after discontinuing therapy.

    Exclusion Criteria:

    • A subject will not be eligible for participation in this study if any of the following criteria apply. 1. Subject's biopsy specimen reveals neuroendocrine or small cell features. 2. Subject has any evidence of metastatic disease (pre-operative staging will be undertaken per urologic standard of care) as deemed by the Investigator. 3. Subject has prior use of any hormones, including luteinizing hormone-releasing hormone (LHRH) agonists, ketoconazole, antiandrogens (such as bicalutamide, flutamide, or nilutamide), or 5-α-reductase inhibitors. 4. Subject has prior use of any anti-cancer treatment or product, such as PC-SPES (or any other PC-x product: PC-HOPE, PC-CARE, PC-PLUS, etc). 5. Subject has received prior radiation therapy or chemotherapy for prostate cancer. 6. Chronic administration (defined as daily or every other day for continuous use >14 days) of systemic corticosteroids within 28 days of the first planned dose off PROSTVAC-V/F. Use of inhaled steroids, nasal sprays, and topical creams for small body areas are allowed. 7. Active atopic dermatitis or skin condition that disrupts the epidermis 8. Inflammatory eye disease requiring steroid treatment 9. History of prior solid organ or bone marrow transplant 10. Previous history of hypersensitivity to eggs or allergy or untoward reaction to prior vaccinia (smallpox) vaccination. 11. Splenectomy 12. Subject, or subject's close household contacts (defined as those who share housing or have close physical contact) have any of the following conditions during the screening and/or treatment periods:
    • active or a history of atopic dermatitis, eczema or other eczematoid skin disorders that disrupt the epidermis
    • other acute, chronic or exfoliative skin conditions (e.g., burns, impetigo, varicella zoster, severe acne or other open rashes or wounds) until condition resolves
    • pregnant or nursing
    • immunodeficient or immunosuppressed (by disease or therapy), including HIV infection 13. Subject's close household contacts include children less than the age of three 14. History of, or active autoimmune disease (e.g., autoimmune neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus erythematosis, Sjogren´s syndrome, scleroderma, myasthenia gravis, Goodpasture´s syndrome, Addison´s disease, Hashimotos´s thyroiditis, or Graves disease) as determined by the treating medical oncologist.
    • Persons with vitiligo are not excluded.
    • Diabetics are not excluded if the condition is well controlled: 1. Hemoglobin A1C < 7.0, and 2. No evidence of end-organ damage due to diabetes, such as diabetic retinopathy, nephropathy, or neuropathy 3. Persons with type 2 diabetes are not excluded since this is not an autoimmune disease, and do not need to meet these criteria.
    • Persons with hypothyroidism are not excluded if condition is well controlled, and condition is due to a non-autoimmune etiology. 15. Subject has received treatment with any investigational immunotherapy within 2 years prior to study screening or has received treatment with any other investigational product within 28 days prior to study screening. 16. Subject has participated in any previous study involving PROSTVAC-V/F, Sipuleucel-T or ipilimumab, regardless of whether the subject received PROSTVAC-V/F, Sipuleucel-T or ipilimumab. 17. Subject has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to PROSTVAC-V/F or ipilimumab. 18. Subject has a history of stage III or greater cancer, excluding prostate cancer. Subjects with a history of basal or squamous cell skin cancers are allowed, provided that the subject was adequately treated and is disease-free at the time of study screening. Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for ≥ 3 years prior to study screening. 19. Subject has any uncontrolled, concurrent illness including, but not limited to the following: ongoing or active infection (bacterial, viral, or fungal), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, stroke or myocardial infarction within 6 months, or psychiatric illness that would limit compliance with study requirements. 20. Subject requires any medical intervention(s) or has any other condition(s) that, in the Investigator's opinion, will 1) make the administration of PROSTVAC or ipilimumab hazardous, 2) obscure the interpretation of AEs, 3) compromise adherence with study requirements, or 4) otherwise compromise the study's objectives. 21. Subject has high-risk features (e.g., based on Gleason score, PSA, clinical stage, % positive biopsies), and the treating physician feels the subject should undergo radical prostatectomy sooner than planned within the protocol.

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published January 10, 2017
  • An Open Registry to Measure the Impact of Adding Genomic Testing (Prolaris®) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients at Intermountain Hospitals

    {{header-clinical-trials-navigation}}

    An Open Registry to Measure the Impact of Adding Genomic Testing (Prolaris®) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients at Intermountain Hospitals


    Condition: Prostate Cancer

    Study Type: Observational [Patient Registry]

    Clinical Trials Identifier NCT 8-digits: NCT02454595

    Sponsor: Myriad Genetic Laboratories, Inc.

    Phase:

    Eligibility:

    • Age: minimum 55 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Newly diagnosed (< or equal to 12 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics:
    • PSA less than or equal to 10 ng/dl and
    • Gleason's 7 (4+3 or 3+4) or Gleason's 6 and
    • Age greater than 55 years old and
    • Clinical Stage T1 or T2
    • Clinically localized (no evidence on clinical or imaging studies of advanced disease).
    • No hormonal therapy including luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, anti-androgen, estrogens or exogenous androgens, when applicable.

    Exclusion Criteria:

    • Known history of hypogonadism

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published January 10, 2017
  • Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial

    {{header-clinical-trials-navigation}}

    Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01368588

    Sponsor: Radiation Therapy Oncology Group

    Phase: Phase 3

    Eligibility:

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

    Disease Characteristics:

    • Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate- to high-risk for recurrence as determined by one of the following combinations:
    • Gleason score 7-10 + T1c-T2b (palpation) + prostate-specific antigen (PSA) < 50 ng/mL (includes intermediate- and high-risk patients)
    • Gleason score 6 + T2c-T4 (palpation) + PSA < 50 ng/mL OR
    • Gleason score 6 + >= 50% (positive) biopsies + PSA < 50 ng/ml
    • Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/mL Patients previously diagnosed with low risk prostate cancer undergoing active surveillance who are re-biopsied and found to have unfavorable intermediate risk disease or favorable high risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure.
    • History and/or physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration
    • Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal CT or MR), (but not by nodal sampling, or dissection) within 90 days prior to registration
    • Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm
    • Patients status post a negative lymph node dissection are not eligible
    • No evidence of bone metastases (M0) on bone scan within 120 days prior to registration (Na F PET/CT is an acceptable substitute)
    • Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis
    • Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 120 days prior to registration
    • Study entry PSA should not be obtained during the following time frames:
    • Ten-day period following prostate biopsy
    • Following initiation of hormonal therapy
    • Within 30 days after discontinuation of finasteride
    • Within 90 days after discontinuation of dutasteride

    Patient Characteristics:

    • Zubrod performance status 0-1
    • Absolute neutrophil count (ANC) ≥ 1,500/mm³
    • Platelet count ≥ 100,000/mm³
    • Hemoglobin (Hgb) ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable)
    • No prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 3 years (1,095 days) and not in the pelvis
    • E.g., carcinoma in situ of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed
    • No prior hematological (e.g., leukemia, lymphoma, or myeloma) malignancy
    • No previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
    • No previous pelvic irradiation, prostate brachytherapy or bilateral orchiectomy
    • No previous hormonal therapy, such as LHRH agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate), estrogens (e.g., DES), or surgical castration (orchiectomy)
    • Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 45 days prior to the date of registration.
    • No severe, active co-morbidity, defined as any of the following:
    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • Transmural myocardial infarction within the last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects or severe liver dysfunction
    • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition
    • Protocol-specific requirements may also exclude immuno-compromised patients
    • HIV testing is not required for entry into this protocol
    • No patients who are sexually active and not willing/able to use medically acceptable forms of contraception
    • No prior allergic reaction to the hormones involved in this protocol

    Prior Concurrent Therapy:

    • See Disease Characteristics
    • No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer
    • No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
    • No prior hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate), estrogens (e.g., diethylstilbestrol (DES) ), or surgical castration (orchiectomy)
    • No prior pharmacologic androgen ablation for prostate cancer unless the onset of androgen ablation is ≤ 45 days prior to the date of registration
    • No finasteride within 30 days prior to registration
    • No dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration
    • No prior or concurrent cytotoxic chemotherapy for prostate cancer
    • Prior chemotherapy for a different cancer is allowable
    • No prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2017
  • Ascertainment of Peripheral Blood or Saliva Samples for Genetic Epidemiology Studies of Familial Cancers

    {{header-clinical-trials-navigation}}

    Ascertainment of Peripheral Blood or Saliva Samples for Genetic Epidemiology Studies of Familial Cancers


    Condition: Breast Neoplasms, Ovarian Neoplasms, Colonic Neoplasms, Prostatic Neoplasms, Uterine Cervical Neoplasms, Leukemia, Lymphoma, Non-Hodgkin

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT00579163

    Sponsor: Memorial Sloan Kettering Cancer Center

    Phase:

    Eligibility:

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

    Inclusion Criteria:

    • Patients accepted for referral to the Cancer Family Clinic of the Department of Medicine at Memorial Sloan-Kettering Cancer Center are eligible for participation in this study. Such patients should have a history of cancers of the breast, ovary, colon, prostate, uterus, non-Hodgkin's lymphoma, leukemia, soft tissue sarcoma, endocrine neoplasms, or other malignancies presenting in first degree relatives or in successive generations as part of a suspected cancer family syndrome.
    • Family members of probands including parents, sisters, brothers, half-brothers and sisters, sons, daughters, grandparents, as well as aunts and uncles are also eligible.
    • This study involves research which presents no greater than minimal risk to children. The assent of any minor should be obtained before the patient is entered into this study.

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2017
  • Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection

    {{header-clinical-trials-navigation}}

    Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection


    Condition: Cancer Prostate

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT03157856

    Sponsor: University Hospital, Grenoble

    Phase:

    Eligibility:

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

    Inclusion Criteria:

    • male patient over 18 years old
    • patient with indication for radical prostatectomy
    • patient with a rectal palpable nodule or targeted MRI positive biopsies or with at least 4 positive biopsies in a hemi-prostate.
    • patient affiliated to French social security system or equivalent
    • patient who have signed a non-opposition form

    Exclusion Criteria:

    • patient with contraindication to radical prostatectomy
    • patient with remedial prostatectomy
    • patient with normal preoperative MRI or with absence of tumoral area
    • patient with history of hormonal therapy
    • person deprived of freedom by judicial or administrative decision
    • person under legal protection
    • person hospitalized for psychiatric care.

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2017
  • Assessment of Tumor Resistance and Stem Cells in Prostate Cancer

    {{header-clinical-trials-navigation}}

    Assessment of Tumor Resistance and Stem Cells in Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT00991315

    Sponsor: Rutgers, The State University of New Jersey

    Phase:

    Eligibility:

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

    Disease Characteristics:

    • Undergoing routine prostatectomy or transurethral resection of the prostate (TURP)

    Patient Characteristics:

    1. 5.1.1 Patient is undergoing routine prostatectomy or TURP. 5.1.2 Patient is ≥ 18 years old. 5.1.3 Patient must give informed consent.

    Prior Concurrent Therapy:

    • See Disease Characteristics

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published March 5, 2017
  • Biospecimen Acquisition From Human Subjects

    {{header-clinical-trials-navigation}}

    Biospecimen Acquisition From Human Subjects


    Condition: Prostate Cancer, Breast Cancer, Colon Cancer, Lung Cancer, Liver Cancer

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT00034216

    Sponsor: National Cancer Institute (NCI)

    Phase:

    Eligibility:

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

    Inclusion Criteria:

    1. Patients with a known or suspected malignancy and healthy volunteers 18 years of age and older are eligible. Performance status of ECOG 0, 1, 2, or 3 for admission to this protocol. Ability to understand and the willingness to sign a written informed consent document. INCLUSION FOR APHERESIS: Note: Effective with Amendment CC, participants will no longer be asked to undergo apheresis. This content is being retained for historical reference. Hemoglobin greater than or equal to 10 mg/dL and platelet count > 75,000/mm(3) Weight greater than 25 kg HIV negative Prothrombin Time within normal limits Partial Thromboplastin Time within normal limits Medically indicated central line in place or adequate peripheral venous access

    Exclusion Criteria:

    1. Children will not be eligible.

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2017
  • BrUOG 337: Olaparib Prior to Radical Prostatectomy For Patients With Locally Advanced Prostate Cancer and Defects in DNA Repair Genes

    {{header-clinical-trials-navigation}}

    BrUOG 337: Olaparib Prior to Radical Prostatectomy For Patients With Locally Advanced Prostate Cancer and Defects in DNA Repair Genes


    Condition: Prostate Cancer, Adenocarcinoma of the Prostate

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03432897

    Sponsor: Dr Anthony Mega

    Phase: Phase 2

    Eligibility:

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

    Inclusion Criteria:

    • Biopsy confirmed adenocarcinoma of the prostate.
    • High risk for recurrence after prostatectomy including any of the following
    • Lymph node involvement by radiographic criteria
    • T3 or T4 disease by radiographic criteria
    • T2 disease and either PSA > 20 or Gleason 8,9 or 10
    • Defects in any of the following genes:BRCA1, BRCA 2, ATM, CHEK1, CHEK2, FANCONIS ANEMIA (FANCL), HDAC2, PALB2, BARD1, BRIP1, CDK12, PPP2R2A, RAD51B, RAD51C, RAD51D, or RAD54L as assessed by Foundation Medicine FoundationOne assay on tumor tissue or cell-free DNA from peripheral blood via the FoundationACT assay.
    • No distant visceral metastases.
    • No prior chemotherapy or radiation for prostate cancer or PARP inhibitor. Prior and current hormone therapy (< 6 months from start date on study) for prostate cancer is allowed. Patients are allowed to remain on hormone therapy on study.
    • ECOG performance status 0-1.
    • Age>18.
    • Required entry laboratory parameters
    • ANC≥ 1,500 cells/mm3;
    • Hemoglobin > 10.0g/dL with no blood transfusion in the last 14 days
    • Platelet count ≥100 x 109/L,
    • Total bilirubin ≤ 1.5 x ULN,
    • AST and ALT ≤ 2.5 x ULN
    • Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of ≥51 mL/min
    • Life expectancy of at least 1 year as documented by treating physician.
    • All Men must be willing to consent to using two highly effective contraception while on treatment and for at least 4 months (120 days) after last treatment on study
    • Signed study-specific consent form prior to study entry.
    • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations- to be documented and submitted to BrUOG.
    • Formalin fixed, paraffin embedded (FFPE) tumor sample from the primary cancer must be available for central testing coordinated by Rhode Island Hospital pathology. If there is not written confirmation of the availability of an archived tumor sample prior to enrollment the patient is not eligible for the study. Submit this written certification to BrUOG
    • Patient agreed to not receiving any live virus and live bacterial vaccines while receiving study medication and during the 30 day follow up period. Patient should be made aware of this and it should be documented to BrUOG.
    • Patient agreed to not consume grapefruit juice while on study treatment. Submit documentation patient was instructed and agreed.

    Exclusion Criteria:

    • Participation in another clinical study with an investigational anticancer product during the last 2 months (from day 1 of treatment on this trial). This pertains to treatment no trials the patient may only be seen in follow-up.
    • Any previous treatment with PARP inhibitor for this or another cancer, including olaparib.
    • Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumors including lymphomas (without bone marrow involvement) which was curatively treated with no evidence of disease for ≥5 years. Diagnosis date and treatment confirmation required to be sent to BrUOG. Certification from treating physician that patient is disease free is required.
    • Resting ECG with QTc > 470 msec on 2 time-points within a 24 hour period or known family history of long QT syndrome
    • Patients receiving any systemic chemotherapy or radiotherapy within 3 weeks prior to study treatment
    • Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
    • Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort ) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
    • Concomitant use of the substrates of CYP3A4, CYP1A2, 2B6, 2C9, 2C19 and P-gp should be cautioned while on study. CYP3A4
    • hormonal contraceptive, simvastatin, cisapride, cyclosporine, ergot alkaloids, fentanyl, pimozide, sirolimus, tacrolimus and quetiapine CYP1A2
    • duloxetine, melatonin CYP2B6
    • bupropion, efavirenz CYP2C9
    • warfarin CYP2C19
    • lansoprazole, omeprazole, S-mephenytoin P-gp
    • simvastatin, pravastatin, digoxin, dabigatran, colchicine OATP1B1
    • bosentan, glibenclamide, repaglinide, statins and valsartan OCT1, MATE1, MATE2K
    • metformin OCT2
    • serum creatinine OAT3 -furosemide, methotrexate
    • Persistent toxicities deemed related to previous cancer therapy, excluding alopecia.
    • Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
    • Patients with brain metastases.
    • Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any prior major surgery.
    • Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
    • Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
    • Immunocompromised patients that according to treating investigator would increase their risk to protocol treatment, or Patients who are known to be serologically positive for human immunodeficiency virus (HIV).
    • Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
    • Patients with known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids
    • Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
    • Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable as long as not within 28 days from study registration).
    • Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published August 19, 2019
  • C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma

    {{header-clinical-trials-navigation}}

    C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma


    Condition: Prostate Cancer, Prostate Adenocarcinoma

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01530269

    Sponsor: Phoenix Molecular Imaging

    Phase: Phase 2

    Eligibility:

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

    Inclusion Criteria:

    • Male patients will be studied who have prostate cancer:
    • Diagnosed with prostate adenocarcinoma
    • Has completed conventional staging examinations, including histologic evaluation with Gleason score, CT scan of the abdomen and pelvis, and whole-body bone scintigraphy Candidate for curative prostatectomy OR curative radiotherapy OR staging lymphadenectomy prior to surgery
    • Deemed to be at intermediate or high risk for recurrence or metastatic disease after initial curative treatment, as defined by of one of the following:
    • Gleason score >= 7 or PSA >= 10
    • Gleason score < 7 or PSA <10 ng/mL with positive surgical margins, biopsy proven or suspected regional nodal involvement or conventional imaging showing limited metastatic disease that may be amenable to directed radiotherapy
    • Rising or non-responding PSA

    Exclusion Criteria:

    • < 18 years old
    • claustrophobic patients

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2017
  • Canary Prostate Active Surveillance Study

    {{header-clinical-trials-navigation}}

    Canary Prostate Active Surveillance Study


    Condition: Prostatic Neoplasms

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT00756665

    Sponsor: University of Washington

    Phase:

    Eligibility:

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

    Inclusion Criteria:

    • Histologically confirmed adenocarcinoma of the prostate.
    • Clinically localized prostate cancer: T1-2, NX or N0, MX or M0.
    • No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
    • ECOG Performance Status 0 or 1.
    • Patient has elected Active Surveillance as preferred management plan for prostate cancer.
    • Patient consent has been obtained according to local Institutional Review Board for acquisition of research specimens.
    • Patient is accessible and compliant for follow-up.
    • Prostate biopsy requirements: 1. If diagnosis was within one year of baseline visit, participant must have at least one biopsy with at least 10 cores. 2. If diagnosis was more than 1 year prior to baseline visit, participant must have a minimum of 2 biopsies, one of which must be within 2 years prior to baseline visit.

    Exclusion Criteria:

    • Unwillingness or inability to undergo serial prostate biopsy.
    • History of other malignancies, except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer (Ta) or other solid tumors curatively treated with no evidence of disease for > 5 years.

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published March 5, 2017
  • Cancer Experience Registry: An Online Initiative to Change the Future of Cancer Care

    {{header-clinical-trials-navigation}}

    Cancer Survivor Registry: The Breast Cancer M.A.P. (Mind Affects the Physical) Project


    Condition: Cancers

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT01295658

    Sponsor: Cancer Support Community, Research and Training Institute, Philadelphia

    Phase:

    Eligibility:

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

    Inclusion Criteria:

    • Having received a cancer diagnosis

    Exclusion Criteria:

    • None

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2017
  • Carbon Ion Radiotherapy for the Treatment of Localized Prostate Cancer

    {{header-clinical-trials-navigation}}

    Carbon Ion Radiotherapy for the Treatment of Localized Prostate Cancer


    Condition: Prostate Carcinoma

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02739659

    Sponsor: Shanghai Proton and Heavy Ion Center

    Eligibility:

    • Age: minimum 20 Years maximum 85 Years
    • Gender: Male

    Inclusion Criteria:

    • Pathologically confirmed adenocarcinoma of the prostate
    • No lymph node and distant metastasis
    • Age ≥ 20 and < 85 years of age
    • Karnofsky Performance Score ≥70
    • No previous pelvic radiation therapy (RT)
    • No previous prostatectomy
    • No previous invasive cancer (within 5 years before the prostate cancer diagnosis)except for skin non-melanoma cancer
    • Ability to understand character and individual consequences of the clinical trial
    • Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial

    Exclusion Criteria:

    • No pathologically confirmed adenocarcinoma of the prostate
    • Pelvic lymph node metastasis (N1)
    • Distant metastasis (M1)
    • Urinary obstructive symptoms (IPSS > 20)
    • Previous pelvic radiotherapy
    • Previous prostatectomy
    • Severe systemic disorders
    • Concomitant disorders including: chronic urinary or intestinal inflammatory conditions (for example, ulcerous recto-colitis, Crohn disease), anti-coagulant treatment (warfarin, heparin)
    • Previous malignancy except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like non muscle invasive bladder cancer
    • Non conformity of the radiotherapy dose distribution when compared to the dose constraints
    • Psychiatric disorders or any other condition that can make unreliable the informed consent

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2017
  • Changes of Immunologic Function in Patients of Prostate Cancer Induced After Cryoablation.

    {{header-clinical-trials-navigation}}

    Changes of Immunologic Function in Patients of Prostate Cancer Induced After Cryoablation.


    Condition: Prostate Cancer

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT02739048

    Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Phase:

    Eligibility:

    • Age: minimum 40 Years maximum 80 Years
    • Gender: Male

    Inclusion Criteria:

    • patients diagnosed with prostate cancer by pathology
    • the age of patients should be from 40 to 80 years old
    • do not receive other treatments like radical prostatectomy, radiotherapy, etc

    Exclusion Criteria:

    • can not receive surgery because of bad performance status
    • abnormal coagulation function
    • receive other treatment before CSAP
    • do not want to achieve CSAP because of any reasons

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2017
  • Characteristics of the Intestinal Microbiota in Patients With Cancer (Catalogue-Onco)

    {{header-clinical-trials-navigation}}

    Characteristics of the Intestinal Microbiota in Patients With Cancer (Catalogue-Onco)


    Condition: Oncology

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03196609

    Sponsor: Centre Georges Francois Leclerc

    Eligibility:

    • Age: minimum 18 Years maximum 75 Years
    • Gender: All

    Inclusion Criteria:

    • Men or women between 18 and 75 years of age.
    • Patients with one of the following types of cancer: non-small cell lung cancer, hepatocellular carcinoma, colorectal cancer, breast cancer, prostate cancer and glioblastoma
    • Patients with informed consent to participate in the study.
    • Affiliation to the social security system

    Exclusion Criteria:

    • For patients with hepatocellular cancer, patients infected with the human immunodeficiency virus (HIV)
    • Patients who are unable to understand, read and / or sign informed consent
    • Patients who can not collect / send stools for geographical, social or psychological reasons
    • Patients with previous cancer in the 5 years preceding this study
    • Persons benefiting from a system of protection for adults (including guardianship and curatorship)
    • Pregnant or nursing women
    • Patients with another synchronous tumor
    • Patients with fecal transplant
    • Patients with chronic inflammatory bowel disease (IBD)
    • Patients having had in the 3 months preceding the collection of stool: colonoscopy, bariatric surgery, surgical removal of a segment of the small intestine (enteritomy or enterostomy), parenteral nutrition.
    • Patients who had had antibiotic therapy within 1 month before stool collection

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2017
  • Circulating Tumor Cell Analysis in Patients With Localized Prostate Cancer Undergoing Prostatectomy

    {{header-clinical-trials-navigation}}

    Circulating Tumor Cell Analysis in Patients With Localized Prostate Cancer Undergoing Prostatectomy


    Condition: Prostate Cancer

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT01961713

    Sponsor: Massachusetts General Hospital

    Phase:

    Eligibility:

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

    Inclusion Criteria:

    • Male
    • 18 years of age or older
    • Pathologically confirmed diagnosis of prostate adenocarcinoma
    • Non-metastatic prostate cancer
    • Planned radical prostatectomy at Massachusetts General Hospital

    Exclusion Criteria:

    • Patients must not have received prior radiation therapy, hormone therapy, or other medical therapy for prostate cancer prior to prostatectomy. Post-prostatectomy therapy at the discretion of the patient's treating physician(s) is allowed.
    • Patients must not have metastatic prostate cancer
    • No prior or current diagnosis of epithelial malignancy, except for skin cancer (squamous cell carcinoma or basal cell carcinoma)

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published January 21, 2018
  • Clinical Validation of a Microfluidic Device for Isolation and Molecular Characterization of Circulating Tumor Cells

    {{header-clinical-trials-navigation}}

    Clinical Validation of a Microfluidic Device for Isolation and Molecular Characterization of Circulating Tumor Cells


    Condition: Cancer

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT01022723

    Sponsor: National Cancer Centre, Singapore

    Phase:

    Eligibility:

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

    Inclusion Criteria:

    • Patients with newly diagnosed metastatic disease planned for palliative chemotherapy
    • Tumor types as specified: non smokers with lung adenocarcinoma, undifferentiated EBV-ISH positive nasopharyneal carcinoma, breast cancer, colorectal cancer, prostate cancer, gastric cancer
    • Informed consent given for the purposes of blood sampling for this study
    • Measurable disease by RECIST criteria of at least 1cm is preferred but not a sine qua non for study accrual

    Exclusion Criteria:

    • N/A

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2017
  • Collection of Blood From Patients With Cancer for Analysis of Genetic Differences in Drug Disposition

    {{header-clinical-trials-navigation}}

    Collection of Blood From Patients With Cancer, Other Tumors, or Tumor Predisposition Syndromes for Analysis of Genetic Differences in Drug Disposition


    Condition: Prostate Cancer, Breast Cancer, Lung Cancer, Ovarian Cancer, Lymphoma

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT01441089

    Sponsor: National Cancer Institute (NCI)

    Phase:

    Eligibility:

    • Age: minimum 3 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    1. Patients with cancer, other tumors, or tumor predisposition syndromes currently enrolled in NIH intramural research program therapeutic trials. Ability of participant or Legally Authorized Representative (LAR) to understand and be willing to sign the informed consent document. Age >= 3 years old

    Exclusion Criteria:

    1. N/A

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2017
  • Collection of Blood From Patients With Prostate Cancer

    {{header-clinical-trials-navigation}}

    Collection of Blood From Patients With Prostate Cancer


    Condition: Cancer Of Prostate, Prostate Cancer, Prostatic Neoplasms, Metastatic Prostate Cancer, Prostate

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT00923221

    Sponsor: National Cancer Institute (NCI)

    Phase:

    Eligibility:

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

    Inclusion Criteria:

    1. Patients 18 years of age and older are eligible. Patients with a diagnosis of prostate cancer are eligible.

    Exclusion Criteria:

    1. Children are not eligible.

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published March 5, 2017
  • Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

    {{header-clinical-trials-navigation}}

    Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Diseases


    Condition: Malignant Neoplasms, Hereditary Neoplastic Syndromes, Kidney Cancer, Renal Cancer, Bladder Cancer

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT00026884

    Sponsor: National Cancer Institute (NCI)

    Phase:

    Eligibility:

    • Age: minimum 2 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • Adult and minor patients with biopsy-proven malignant disease
    • Adult and minor patients suspected of having a malignant disease
    • Patients who have or are suspected of having an inherited genitourinary malignant disorder
    • Participants must be >= 2 years of age
    • Family members (related by blood) of patients who have or are suspected of having a malignant disease or an inherited genitourinary malignant disorder.
    • All patients and guardians, for children younger than 18 years of age, must sign an informed consent document indicating their understanding of the investigational nature and the risks of this study before any protocol related studies are performed. Patients under the age of 18 but who are age 13 or older will be asked to sign an assent document prior to participation.

    Exclusion Criteria:

    • Subjects whose co-morbidities preclude surgical intervention.

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2017
  • Comparative effectiveness of radical prostatectomy and curative radiotherapy in localized prostate cancer: long-term follow-up.

    We sought to investigate the long-term outcomes after radical prostatectomy (RP) and external-beam radiation therapy (EBRT) for the treatment of localized prostate cancer in Japanese patients. RP and radiation therapy are curative treatments for localized prostate cancer.

    Published December 27, 2016
  • Comparison of High-dose- Versus Low-dose-rate Brachytherapy as Monotherapy in the Treatment of Early, Organ Confined Prostate Cancer.

    {{header-clinical-trials-navigation}}

    Comparison of High-dose- Versus Low-dose-rate Brachytherapy as Monotherapy in the Treatment of Early, Organ Confined Prostate Cancer.


    Condition: Adenocarcinoma of Prostate

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02258087

    Sponsor: National Institute of Oncology, Hungary

    Phase: Phase 2/Phase 3

    Eligibility:

    • Age: minimum 40 Years maximum 75 Years
    • Gender: Male

    Inclusion Criteria:

    • Eastern Cooperative Oncology Group (ECOG) status <=1
    • 40-75 years old
    • expected life expectancy>10 years
    • low risk prostate cancer (Prostate specific antigen (PSA)<=10ng/ml, gleason score <7, T status<=2a), less than 50 % positive biopsy cores
    • selected intermediate prostate cancer (PSA)=10-<15ng/ml or gleason score =3+4(but not 4+3), or T2b-c, less than 50 % positive biopsy cores)
    • International prostate symptom score (IPSS) <=15
    • Prostate volume<=50cm3
    • no pubic interference
    • no prior prostate operation, except biopsy
    • no prior radiation to pelvis
    • patient signed the informed consent

    Exclusion Criteria:

    • <40 years or >75 years old
    • PSA>15 ng/ml gleason score 4+3 , score 8-10
    • ECOG>=2
    • T3-4
    • percent core positivity >50 %
    • TUR operation within six months prior to the brachytherapy prostate volume<10 cm3 or >50 cm3 IPSS >15

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published January 10, 2017
  • Comparisons of oncological and functional outcomes among radical retropubic prostatectomy, high dose rate brachytherapy, cryoablation and high-intensity focused ultrasound for localized prostate cancer.

    To conduct a retrospective, single institutional and comparative study for radical retropubic prostatectomy (RRP), high dose rate brachytherapy (HDRBT), cryoablation and high-intensity focused ultrasound (HIFU) in localized prostate cancer with respect to oncological and functional outcomes.

    Published December 27, 2016
  • Comprehensive Analysis of Hypoxia in Prostate Cancer: Diagnostic Markers and Prognostic Significance

    {{header-clinical-trials-navigation}}

    Comprehensive Analysis of Hypoxia in Prostate Cancer: Diagnostic Markers and Prognostic Significance


    Condition: Prostate Cancer

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT01191099

    Sponsor: University of Zurich

    Phase:

    Eligibility:

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

    Inclusion Criteria:

    • Patients with biopsy-proven adenocarcinoma of the prostate who are to be treated with radical prostatectomy at the Department of Urology, University Hospital of Zurich
    • Written informed consent

    Exclusion Criteria:

    • Metastatic prostate cancer
    • Contraindications to the class of investigational product under study, e.g. known hypersensitivity or allergy to the investigational product
    • Severe heart or lung disease
    • Severe liver or kidney dysfunction
    • Severe stridor
    • Distant metastases
    • Concurrent treatment for other malignant disease
    • Prior hormonal therapy or radiotherapy

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2017
  • Conventional and Contrast-Assisted Frequency Functional Ultrasound for Imaging of Prostate Cancer Extent and Response in Human Cancer Patients

    {{header-clinical-trials-navigation}}

    Conventional and Contrast-Assisted Frequency Functional Ultrasound for Imaging of Prostate Cancer Extent and Response in Human Cancer Patients


    Condition: Prostate Cancer

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT01401972

    Sponsor: Sunnybrook Health Sciences Centre

    Phase:

    Eligibility:

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

    Inclusion Criteria:

    • Prostate Cancer

    Exclusion Criteria:

    • Not having radical prostatectomy surgery

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2017
  • Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Men Managed With Active Surveillance for Prostate Cancer

    {{header-clinical-trials-navigation}}

    Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Men Managed With Active Surveillance for Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03290417

    Sponsor: Case Comprehensive Cancer Center

    Eligibility:

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

    Inclusion Criteria:

    • Subjects must have the diagnosis of prostate cancer and be on active surveillance. For the purpose of this study, Active surveillance implies prostate-specific antigen (PSA)<10 ng/mL, biopsy Gleason sum
    • Subjects must be followed at the Cleveland Clinic for active surveillance.
    • Subjects must be willing to adhere to the dietary modification outlined in the protocol.
    • Subjects must be willing to have prostate biopsies at the baseline, and six months after enrollment into the protocol
    • Subjects must have the ability to understand and the willingness to sign a written informed consent document.

    Exclusion Criteria:

    • Subjects receiving any treatment other than AS for prostate cancer.
    • Subjects not followed by the Cleveland Clinic.
    • Subjects unable to adhere to the dietary modification outlined in the protocol.

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 4, 2018
  • Cystoprostatectomy Versus Radiotherapy Combined With Androgen Deprivation Therapy for the Treatment of Clinical T4 Prostate Cancer With Bladder Invasion: a Multicentre, Prospective, Open, Randomized Clinical Trial

    {{header-clinical-trials-navigation}}

    Cystoprostatectomy Versus Radiotherapy Combined With Androgen Deprivation Therapy for the Treatment of Clinical T4 Prostate Cancer With Bladder Invasion: a Multicentre, Prospective, Open, Randomized Clinical Trial


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03482089

    Sponsor: Tongji Hospital

    Eligibility:

    • Age: minimum 18 Years maximum 75 Years
    • Gender: Male

    Inclusion Criteria:

    1. Age ≤75, at the time of randomization
    2. Newly diagnosed primary prostatic adenocarcinoma confirmed by pathological examination of biopsy;diagnosed within 6 months prior to randomization
    3. Untreated for surgery, radiotherapy, or androgen deprivation therapy
    4. Eastern Cooperative Oncology Group (ECOG) performance status 0- 2; American Standards Association (ASA) classification I-III
    5. A life expectation of at least 10 years
    6. Tumor stage (T, M, N): Clinical T4N0M0 with bladder invasion (confirmed by MRI)
    7. Eligible for either treatment of cystoprostatectomy or radiotherapy
    8. Signed informed consent should be obtained from both the patient or one authorized legal relative.

    Exclusion Criteria:

    1. Patients with a history of other cancer diagnoses except non-melanoma skin cancer
    2. Patients with pelvic surgery
    3. Patients with severe systemic diseases
    4. severe kidney function -glomerular filtration rate (GFR) < 30 ml/min or elevated liver transaminases above > 10 upper limit of normal (ULN)
    5. Patients who are not able comply with scheduled follow-up visits and examinations with the consideration of patients' physical or mental condition

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published December 12, 2018
  • Detection and Localization of Carcinoma Using High Resolution Transrectal Imaging - Proof of Concept Study

    {{header-clinical-trials-navigation}}

    Detection and Localization of Carcinoma Using High Resolution Transrectal Imaging - Proof of Concept Study


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02786459

    Sponsor: University Health Network, Toronto

    Eligibility:

    • Age: minimum 30 Years maximum 75 Years
    • Gender: Male

    Inclusion Criteria:

    • Group 1: Rising PSA (biochemical failure) following radical prostatectomy. Group 2: Rising PSA (>10ng/ml) and/or abnormal digital rectal exam suspicious for prostate cancer. Previously negative prostate biopsies. Group 3: Scheduled biopsy for known PCa (patient on AS). At least 1 previously positive prostate biopsy for adenocarcinoma of the prostate. Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    • Sufficient time period to complete the imaging protocol and 7 to 9 day safety follow-up assessment without therapeutic intervention.
    • Patient is judged by the Investigator to have the initiative and means to provide written consent and be compliant with the protocol and be able and commits to make the required study visits.
    • Ambulatory with ECOG performance status of 0 or 1 (see appendix section).
    • Patient is between 35 and 75 years of age.

    Exclusion Criteria:

    • The presence of any of the following will exclude a patient from study enrollment:
    • Patient or physician plans definitive concomitant chemotherapy, therapeutic radiation treatment, biologic treatment and/or local ablative treatment for cancer within the interval of study participation.
    • Patients with pacemakers, neurostimulators, and foreign metal bodies will be excluded as they will be unable to undergo an MRI and SPECT-CT.
    • Prior history of murine antibody infusion, patients who are hypersensitive to products of murine origin or indium-111 chloride.
    • Prior therapeutic pelvic irradiation.
    • Recent prostate biopsy, within 1 month of study enrollment.
    • Patient with contraindications to TRUS-guided prostate biopsy (continuous need for anti-coagulation, no rectum, etc.)
    • Clinical evidence of prostatitis, or other benign prostate gland abnormality, that would explain elevated PSA and/or (digital rectal exam) DRE findings.
    • Active malignancy or therapy for malignancy within 6 months, other than basal or squamous cell carcinoma of the skin.
    • Patient received a radiopharmaceutical which was within 5 physical half-lives at the time of study imaging.
    • Severe psychiatric or medical illness that may interfere with compliance with the study protocol or follow-up as deemed by the investigator.

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published January 22, 2017
  • Development and Testing of a Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer

    {{header-clinical-trials-navigation}}

    Development and Testing of a Culturally Tailored Decision Aid for Hispanic Patients Diagnosed With Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03157947

    Sponsor: Case Comprehensive Cancer Center

    Eligibility:

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

    Inclusion Criteria:

    • Subjects utilize English or Spanish as their primary spoken or written language and identify with a Latino ethnicity and/or culture
    • Men with a new histologic diagnosis of localized prostate cancer
    • PSA level of 0.1
    • 50 ng/dl
    • Gleason score of 6
    • 10
    • Cancer stage: T1
    • 4N x M0

    Exclusion Criteria:

    • Metastatic disease, including lymph nodes or distant metastasis
    • PSA > 50 ng/dl
    • Individuals with a medical condition that necessitates a specific prostate cancer treatment plan
    • Individuals that are unwilling or unable to attend study visits or are planning to move out of a study site coverage area during the subject's anticipated participation in the study

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published October 16, 2017
  • Diagnosing Clinically Significant Prostate Cancer in African American and White Men Phase II, Randomized Clinical Trial, Multi-center, MR-Guided vs. 12-core Systematic Random Biopsy, Localized Prostate Cancer

    {{header-clinical-trials-navigation}}

    Diagnosing Clinically Significant Prostate Cancer in African American and White Men Phase II, Randomized Clinical Trial, Multi-center, MR-Guided vs. 12-core Systematic Random Biopsy, Localized Prostate Cancer


    Condition: Health Status Unknown, Elevated PSA

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03234556

    Sponsor: University of Southern California

    Eligibility:

    • Age: minimum 40 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
    • Note: HIPAA authorization may be included in the informed consent or obtained separately
    • Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 3 months (93 days) prior to being registered for protocol
    • African-American or white men (Hispanic or non-Hispanic)
    • Prostate biopsy-naive or a single negative biopsy
    • Having elevated prostate specific antigen (PSA) (> 2.5 ng/ml) and no palpable nodule on digital rectal exam (DRE)
    • Ability to understand the willingness to sign a written informed consent
    • Patients must be willing to undergo a radiologic imaging before and after biopsy of the prostate
    • Patients must be willing to undergo a biopsy of the prostate

    Exclusion Criteria:

    • Patients who have had chemotherapy or radiotherapy within 12 months of the study for other diagnoses not related to prostate cancer
    • Patients receiving any other investigational agents
    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
    • Patients with active inflammatory bowel disease
    • Patients who are unable to undergo MRI
    • Patients who had any surgery of the prostate including TURP (transurethral resection of the prostate)
    • Patients who had > 1 prior prostate biopsy

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published October 16, 2017
  • Early Changes in Multiparametric MRI in Response to Neoadjuvant Androgen Deprivation and External Beam Radiation Therapy for Prostate Cancer

    {{header-clinical-trials-navigation}}

    Early Changes in Multiparametric MRI in Response to Neoadjuvant Androgen Deprivation and External Beam Radiation Therapy for Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01959542

    Sponsor: Dana-Farber Cancer Institute

    Eligibility:

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

    Inclusion Criteria:

    • Adult males with unfavorable intermediate- to high-risk localized disease, defined as having one of the following three categories, Clinical or radiographic T2b-T4 primary tumor or Gleason score 7-10 in any core, or PSA ≥ 10 prior to initiation of therapy
    • Patients are deemed suitable for therapy with ADT and EBRT.
    • Subjects must to able to provide informed written consent prior to study entry. Exclusion Criteria:
    • The standard

    Exclusion Criteria:

    • The standard exclusion criteria for MRI exams will apply which include patients with pacemakers, non-compatible intra-cranial vascular clips, inner ear implants, and severe claustrophobia.
    • Patients who because of age, general medical or psychiatric condition, or physiologic status unrelated to the presence of prostate cancer are unlikely to be candidates for repeat MRIs, or cannot give valid informed consent.
    • Patients unwilling or unable to undergo the multiparametric MRI exam (non-endorectal coil).
    • Patients with a history of allergic reaction to latex or Gadolinium containing intravenous contrast agents.
    • Individuals with renal disease or other contraindications to gadolinium will be excluded. The BWH standard MRI contrast screening criteria will be used to establish renal status.
    • Patients who have had prior prostatectomy or prior androgen therapy.
    • Patients with hip implant or any other metallic implant or device that results in significant distortion of the local magnetic field and compromise of the quality of the multiparametric MRI data.

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published January 10, 2017
  • Effect of Different Exercise Regimens on Intratumoral Natural Killer (NK) Cell Variability in Men With Localized Prostate Cancer Undergoing Radical Prostatectomy - a Randomized Controlled Pilot Study

    {{header-clinical-trials-navigation}}

    Effect of Different Exercise Regimens on Intratumoral Natural Killer (NK) Cell Variability in Men With Localized Prostate Cancer Undergoing Radical Prostatectomy - a Randomized Controlled Pilot Study


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02954783

    Sponsor: Rigshospitalet, Denmark

    Eligibility:

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

    Inclusion Criteria:

    • Pathologically verified localized prostate cancer
    • Eligible for curative radical prostatectomy

    Exclusion Criteria:

    • Any other known malignancy requiring active treatment
    • Performance status > 1
    • Ongoing treatment with beta blockers
    • Physical disabilities precluding physical testing and/or exercise
    • Inability to read and understand Danish

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published January 10, 2017
  • Epidural or Patient-controlled Analgesia for Colorectal Cancer Surgery. Long-term Outcomes.

    {{header-clinical-trials-navigation}}

    Epidural or Patient-controlled Analgesia for Colorectal Cancer Surgery. Long-term Outcomes.


    Condition: Colorectal Cancer, Pain, Other Complications

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01318161

    Sponsor: Örebro University, Sweden

    Phase: Phase 3

    Eligibility:

    • Age: minimum 40 Years maximum 80 Years
    • Gender: All

    Inclusion Criteria:

    • ASA status 1-3
    • Age group 40-80 years old
    • Undergoing elective surgery for colorectal cancer

    Exclusion Criteria:

    • All contraindications to epidural analgesia
    • Chronic opiate medication/drug abuse
    • Allergy to morphine

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2017
  • Erythropoietin to Enhance Erection Recovery in Men Following Radical Prostatectomy

    {{header-clinical-trials-navigation}}

    Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy: a Prospective Randomized Controlled Trial (ERECT)


    Condition: Prostate Cancer, Erectile Dysfunction

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT00737893

    Sponsor: Johns Hopkins University

    Phase: Phase 2

    Eligibility:

    • Age: minimum 40 Years maximum 65 Years
    • Gender: Male

    Inclusion Criteria:

    • Patient eligibility consists of men 40 to 65 years of age
    • Localized prostate cancer
    • clinical stage T2a or lower
    • Gleason grade of 3+4 or 3+3
    • prostate specific antigen (PSA) < 10
    • Scheduled to undergo curative prostatectomy applying bilateral nerve-sparing procedure, with intact pre-surgical erectile function
    • International Index of Erectile Function-5 [IIEF-5] score of 22-25.
    • The patient has a sexual partner, of at least 6 months.
    • The patient's pre-surgical hematocrit is ≤ 48.
    • The patient is willing to attempt intercourse at least 5 times per month following recovery from surgery.

    Exclusion Criteria:

    • The patient has known penile deformity or a history of Peyronie's disease.
    • The patient has planned pre or post operative androgen therapy.
    • The patient has planned pre or post operative radiation therapy.
    • The patient is on anticoagulation therapy.
    • The patient has a history of sickle cell anemia.
    • The patient has a history of high or low blood pressure that is not controlled.
    • The patient is taking medications called "nitrates"
    • The patient has a history of heart problems such as angina, heart failure, irregular heartbeats, or myocardial infarction
    • The patient has a history of history of drug or alcohol abuse.
    • The patient currently smokes or has a 20 pack/year history of cigarette smoking.
    • The patient has a history of acute or chronic depression
    • The patient has a history liver problems, or kidney problems.
    • The patient has a history of retinitis pigmentosa or severe vision loss, including a condition called NAION, Nonarteritic Anterior Ischemic Optic Neuropathy.
    • The patient has a history of spinal trauma or surgery to the brain or spinal cord.
    • The patient has contraindications to the use of phosphodiesterase type 5 (PDE 5) inhibitors.
    • Patient is currently participating in another clinical investigation that would serve as a contraindication to administering erythropoietin.

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published January 10, 2017
  • Evaluation for NCI Radiation Oncology Branch Clinical Research Protocols

    {{header-clinical-trials-navigation}}

    Evaluation for NCI Radiation Oncology Branch Clinical Research Protocols


    Condition: Prostate, Brain, Breast, Lung, Endometrial

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT00026689

    Sponsor: National Cancer Institute (NCI)

    Phase:

    Eligibility:

    • Age: minimum N/A maximum 90 Years
    • Gender: All

    Inclusion Criteria:

    1. Patients suspected of having, or with biopsy proven malignant disease or patients with a benign condition for whom radiotherapy is a potential treatment. Patient or guardian is able to provide informed consent.

    Exclusion Criteria:

    1. Candidates who do not meet the inclusion criteria.

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published February 6, 2017
  • Evaluation of the TULSA-PRO MRI-guided Transurethral Ultrasound Prostate Ablation Device in Patients With Localized Prostate Cancer

    {{header-clinical-trials-navigation}}

    Evaluation of the TULSA-PRO MRI-Guided Transurethral Ultrasound Prostate Ablation Device in Patients With Localized Prostate Cancer: a Prospective, Single-Arm, Pivotal Clinical Study


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02766543

    Sponsor: Profound Medical Inc.

    Eligibility:

    • Age: minimum 45 Years maximum 80 Years
    • Gender: Male

    Inclusion Criteria:

    1. Male, age 45 to 80 years
    2. Biopsy-confirmed adenocarcinoma of the prostate. Biopsy (minimum 10 cores) obtained ≥ 6 weeks and ≤ 6 months before treatment (or at the discretion of PI and approval by the Sponsor).
    3. Clinical stage ≤ T2b 4.1 Gleason score ≤ 3 + 4 (Part I only) 4.2 Gleason score 3+4 (Part II only) *now recruiting
    4. PSA ≤ 15 ng/ml
    5. Eligible for MRI [Form GCP-10131]
    6. Eligible for general anesthesia (ASA category ≤ 3)
    7. Prostate volume ≤ 90 cc, on Baseline MRI
    8. Prostate size ≤ 5.0 cm in sagittal length, and ≤ 6.0 cm in axial diameter, on Baseline MRI
    9. Life expectancy ≥ 10 years
    10. No calcifications in the planned ultrasound beam path, or at the discretion of the investigator with approval from the Sponsor. Exclusion Criteria:
    11. Evidence (including Baseline MRI and bone scan) of extracapsular extension, sphincter involvement, seminal vesicle invasion, lymph node invasion or metastases
    12. Suspected tumour on Baseline MRI within 3 mm of the prostatic urethra, or in the prostate apex within 3 mm from the sphincter plane
    13. Prior definitive treatment of prostate cancer
    14. Prior transurethral resection of the prostate (TURP)
    15. Use of 5-alpha reductase inhibitors (5-ARIs) or hormone therapy within 3 months prior to the baseline visit. Baseline PSA must be established after a minimum of 3 months following 5-ARIs discontinuation. Additionally, use of 5-ARIs is not permitted following treatment during the study follow-up period.
    16. Prostate calcifications > 1 cm in largest diameter, on Baseline Ultrasound
    17. Cysts > 1 cm in largest diameter, on Baseline MRI
    18. Bleeding disorder (INR > ULN and PTT > ULN)
    19. Abnormal coagulation and current anticoagulant therapy. Patients whose anticoagulation therapy can be temporarily reversed within 7 days prior to treatment are eligible. Platelet inhibitors (ie: ASA) and heparin are not

    Exclusion Criteria:

    1. Evidence (including Baseline MRI and bone scan) of extracapsular extension, sphincter involvement, seminal vesicle invasion, lymph node invasion or metastases
    2. Suspected tumour on Baseline MRI within 3 mm of the prostatic urethra, or in the prostate apex within 3 mm from the sphincter plane
    3. Prior definitive treatment of prostate cancer
    4. Prior transurethral resection of the prostate (TURP)
    5. Use of 5-alpha reductase inhibitors (5-ARIs) or hormone therapy within 3 months prior to the baseline visit. Baseline PSA must be established after a minimum of 3 months following 5-ARIs discontinuation. Additionally, use of 5-ARIs is not permitted following treatment during the study follow-up period.
    6. Prostate calcifications > 1 cm in largest diameter, on Baseline Ultrasound
    7. Cysts > 1 cm in largest diameter, on Baseline MRI
    8. Bleeding disorder (INR > ULN and PTT > ULN)
    9. Abnormal coagulation and current anticoagulant therapy. Patients whose anticoagulation therapy can be temporarily reversed within 7 days prior to treatment are eligible. Platelet inhibitors (ie: ASA) and heparin are not exclusion criteria.
    10. Acute unresolved Urinary Tract Infection (UTI)
    11. Interest in future fertility
    12. History of any other malignancy other than skin cancer, or low grade bladder cancer which has been completely resected, within the previous 2 years. Patients that have had curative treatment of a previous malignancy and no recurrence of that malignancy within the past 2 years will be allowed.
    13. Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome
    14. Patients with diabetes who have evidence of complications from their diabetes, such as end organ sequelae of diabetes or Hemoglobin A1c > 7%.
    15. History of any major rectal or pelvic surgery or radiotherapy
    16. History of ulcerative colitis or other chronic inflammatory conditions affecting rectum (includes rectal fistula, anal stenosis)
    17. Documented clinical prostatitis requiring therapy within 6 months prior to Treatment
    18. History of urethral and bladder outlet disorders, including urethral stricture disease, urethral diverticulae, bladder neck contracture, urethral fistulae, urethral stenting, urethral sling, urethroplasty or chronic indwelling urethral catheter
    19. Patients with artificial urinary sphincter or any penile implant
    20. Severe neurogenic bladder
    21. Untreated bladder stones
    22. History of acute urinary retention within the last 12 months
    23. Active untreated gross hematuria for any cause
    24. Post Void Residual (PVR) bladder volume > 250 mL
    25. Obstructing median lobe enlarged out of proportion to the rest of the prostate and protruding significantly into the bladder, sometimes referred to as "ball valve" median lobe, determined on Baseline MRI
    26. Any prostate related investigational therapy within 6 months of Visit 1
    27. History of Parkinson's disease or multiple sclerosis
    28. History of drug abuse
    29. Known infectious disease including HIV positivity or AIDS-related illness, HBV and HCV
    30. Current unilateral or bilateral hydronephrosis
    31. Allergy or contraindications to administration of the GI anti-spasmodic drug:
    32. Patients in the USA: Glucagon
    33. Patients in Canada and Europe: Buscopan (Hyoscine)
    34. Contraindications to administration of gadolinium-based MRI contrast agent (e.g. Magnevist), such as chronic, severe kidney disease, acute kidney injury, history of Sickle Cell Disease, history of anemia, or intolerance/allergy to the contrast agent
    35. Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published January 21, 2018
  • Feasibility Study of Radiation Therapy and IRreversible Electroporation for Intermediate Risk Prostate Cancer (RTIRE)

    {{header-clinical-trials-navigation}}

    Radiation Therapy and IRreversible Electroporation for Intermediate Risk Prostate Cancer (RTIRE)


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT05345444

    Sponsor: Weill Medical College of Cornell University

    Eligibility:

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

    Inclusion Criteria:

    • 1. Men aged ≥ 18 2. ECOG 0
    • 1 3. Histologically confirmed intermediate risk prostate cancer per NCCN guidelines. 4. Focal grade group 2 or 3 (GS 3+4 or GS 4 + 3) cancer in MRI target 5. Gland size < 80 cc 6. Ability to undergo IRE 7. Ability to receive MRI-guided radiotherapy. 8. Ability to complete the HRQOL assessment surveys 9. Willingness to undergo 12 month follow up biopsy

    Exclusion Criteria:

    1. Prior history of focal therapy.
    2. Prior history of receiving pelvic radiotherapy.
    3. Patient with metastatic prostate cancer.
    4. Patient with history of inflammatory bowel disease.
    5. Inability to undergo general anesthesia
    6. Inability to be placed within the lithotomy position for a transperineal approach to both biopsy and treatment.
    7. Patients with a prior or concurrent disease whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ or low-grade non-muscle invasive bladder cancer) who has been disease-free for less than 3 years must contact the Principal Investigator.
    8. History of bladder neck or urethral stricture.

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2023
  • Focal Low Dose Rate ( LDR) Brachytherapy: Hemi-ablative Treatment With LDR for Patients With Low and Low-tier Intermediate Risk Prostate Cancer

    {{header-clinical-trials-navigation}}

    Focal Low Dose Rate ( LDR) Brachytherapy: Hemi-ablative Treatment With LDR for Patients With Low and Low-tier Intermediate Risk Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02643511

    Sponsor: St George Hospital, Australia

    Phase: Phase 2

    Eligibility:

    • Age: minimum 60 Years maximum N/A
    • Gender: Male

    Inclusion Criteria:

    • 1. Patients must have histologically proven adenocarcinoma of the prostate. 2. Patients must have low or low-tier intermediate prostate cancer
    • Low risk prostate cancer patients must have:
    • Clinical stage ≤ T2a,
    • Gleason score =6 and iPSA ≤ 10 ng/ml
    • < 25% cores positive, < 50 % cancer in each core involved
    • Low tier Intermediate risk patients may have:
    • Clinical stageT2a
    • Gleason score ≤ 3+4=7
    • PSA ≤ 10 ng/ml
    • < 25% cores positive, < 50 % cancer in each core 3. Patients must be fit for general anesthetic. 4. Patients must have unilateral disease on biopsy 5. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0
    • 2. 6. Men ≥ 65 years of age with a life expectancy estimated to be >10 years. 7. Patients must have no contraindications to interstitial prostate brachytherapy. 8. Patients on anticoagulant therapy must be able to stop therapy safely for at least 7 days. 9. Patients must not have any contraindications to MRI 10. IPSS <=16

    Exclusion Criteria:

    1. Does not meet staging criteria for low risk or low tier intermediate risk prostate cancer
    2. Bilateral prostatic disease
    3. Prior hormonal therapy
    4. Prior Transurethral resection or middle lobe resection
    5. Recent IPSS>
    6. Unfit for general anesthetic
    7. MRI contraindicated
    8. Unable to cease anticoagulant therapy
    9. Life expectancy < 10 years
    10. IPSS>16

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published January 12, 2017
  • Focal MR-Guided Focused Ultrasound Treatment of Localized Low and Intermediate Risk Prostate Cancer: Feasibility Study

    {{header-clinical-trials-navigation}}

    Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions


    Condition: Localized Intermediate Risk Prostate Lesions

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01657942

    Sponsor: InSightec

    Eligibility:

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

    Inclusion Criteria:

    • Biopsy proven adenocarcinoma of the prostate (using a IMAGE-guided 14+ core mapping biopsy), and targeted cores as needed obtained up to 6 months prior to scheduled treatment
    • Patient with intermediate risk, early-stage organ-confined prostate cancer (T1a up to T2b, N0, M0) and voluntarily chooses ExAblate thermal ablation as the non-invasive treatment, who may currently be on watchful waiting or active surveillance and not in need of imminent radical therapy.
    • Patient with PSA less than or equal to 20 ng/mL
    • Gleason score 7 (4 + 3 or 3 + 4), based on mapping prostate biopsy, with no more than 15mm cancer in maximal linear dimension in any single core
    • Single hemilateral index Gleason 7 lesion, identified in the prostate based on biopsy mapping with supporting MRI; may have secondary Gleason 6 lesion on ipsilateral or contralateral side confirmed with biopsy and/or MRI

    Exclusion Criteria:

    • Contraindications to MRI
    • History of orchiectomy, PCa-specific chemotherapy, brachytherapy, cryotherapy, Photodynamic therapy or radical prostatectomy for treatment of prostate cancer; any prior radiation therapy to the pelvis for prostate cancer or any other malignancy
    • Patient under medications that can affect PSA for the last 3 months prior to MRgFUS treatment (Androgen Deprivation Treatment; alpha reductase inhibitors)
    • Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (approximately 3 hrs. sonication time)
    • Any rectal pathology, anomaly or previous treatment, which could change acoustic properties of rectal wall or prevent safe probe insertion (e.g., stenosis, fibrosis, inflammatory bowel disease, etc.)
    • Evidence of distant prostate cancer, i.e., including lymph nodes and/or metastasis of cancer on imaging
    • Bladder cancer
    • Urethral stricture/bladder neck contracture
    • Prostatitis NIH categories I, II and III
    • Implant near (<1 cm) the prostate

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published January 12, 2017
  • Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Intermediate Risk Prostate Cancer: Feasibility Study

    {{header-clinical-trials-navigation}}

    Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Intermediate Risk Prostate Cancer: Feasibility Study


    Condition: Localized Low-Intermediate Risk Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT01226576

    Sponsor: InSightec

    Eligibility:

    • Age: minimum 50 Years maximum 75 Years
    • Gender: Male

    Inclusion Criteria:

    1. Patient of age between 50 to 75 years, inclusive.
    2. Biopsy confirmed adenocarcinoma of the prostate, performed up to 6 months prior to scheduled treatment.
    3. Patient with low-intermediate risk, early-stage organ-confined prostate cancer (cT1c and cT2a, N0, M0), diagnosed with TRUS guided transperineal biopsy (TPBx) and voluntarily chooses MRgFUS as the non-invasive treatment, who may currently be on watchful waiting or active surveillance and not in need of imminent radical therapy.
    4. Patient with PSA less than or equal to 10 ng/mL
    5. Gleason score 6 or 7 (no 5 grades), based on TRUS guided Transperineal Mapping Biopsy, as defined in the protocol.
    6. Up to two (2) cancerous lesions may be identified in the prostate; each tumor is not more than 10 mm in maximal linear dimension; each tumor should comply with the maximal 7 Gleason score requirement.
    7. Positive TRUS-guided transperineal biopsy (TPBx) cores, detected in a maximum of four (4) sectors, (2 for each cancerous focus) out of 16 sectors (or out of 12 sectors in prostates with volume <20 cc)
    8. Low grade tumors may or may not be visible by multi-parametric MRI. Thus, in case of MRI-visible tumor, tumor should be in capsular contact of less than 5 mm, on axial images.
    9. No definite evidence of extracapsular extension or seminal invasion by MRI
    10. Patient eligible for epidural anesthesia, and general anesthesia (in case of complication, requiring intervention).
    11. Patient is willing and able to give consent and attend all study visits as defined in the protocol
    12. Prostate gland volume should be no greater than 70 cc, volumetrically measured.

    Exclusion Criteria:

    1. ASA status > 2
    2. Contraindications to MRI 2.
    3. Claustrophobia 2.
    4. Implanted ferromagnetic materials or foreign objects 2.
    5. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist) 2.
    6. Known contraindication to utilization of MRI contrast agent
    7. Severely abnormal coagulation (INR>1.5)
    8. Patient with unstable cardiac status including: 4.
    9. Unstable angina pectoris on medication 4.
    10. Documented myocardial infarction within 40 days prior to enrolment 4.
    11. Congestive heart failure NYHA class IV 4.
    12. Unstable arrhythmia status, already on anti-arrhythmic drugs
    13. Severe hypertension (diastolic BP > 100 on medication)
    14. Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
    15. History of orchiectomy, PCa-specific chemotherapy, cryotherapy, Photodynamic therapy or radical prostatectomy for treatment of prostate cancer; any prior radiation therapy to the pelvis for prostate cancer or any other malignancy.
    16. Patient under medications that can affect PSA for the last 3 months prior to MRgFUS treatment (Androgen Deprivation Treatment; alpha reductase inhibitors)
    17. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (approximately 3 hrs.)
    18. Any rectal pathology, anomaly or previous treatment, which can change acoustic properties of rectal wall or prevent safe probe insertion (e.g., fistula, stenosis, fibrosis).
    19. Any spinal pathology which can prevent safe administration of epidural anesthesia
    20. Identified calcification of 2 mm or more in largest diameter neighboring the rectal wall (in a distance of less than 5 mm) and interfering with the acoustic beam path.
    21. Lower limb musculo-skeletal fixed deformities.
    22. Prostate with multiple cystic lesions.
    23. Evidence for seminal vesicle/lymph node involvement of cancer.
    24. Subjects with distance of the less than 2mm margin between the tumor and the prostate capsule
    25. Bladder cancer
    26. Patient that had TURP procedure before
    27. Urethral stricture/bladder neck contracture
    28. Patient with baseline symptoms of incontinence defined as urine leak in any of the following circumstances: 20.
    29. Before the patient can get to the toilet 20.
    30. When coughing or sneezing 20.
    31. While being asleep 20.
    32. While being physically active/exercising 20.
    33. After finishing urinating and being dressed 20.
    34. Leaking for no obvious reason
    35. Patient with baseline impotence scoring 17 or below in the IIEF-5 (SHIM) questionnaire
    36. Active UTI
    37. Prostatitis NIH categories I, II and III
    38. Implant near (<1 cm) the prostate
    39. Interest in future fertility
    40. Current participation in another clinical investigation of a medical device or a drug or has participated in such a study within 30 days prior to study enrollment

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published January 12, 2017
  • Focal Prostate Radio-Frequency Ablation for the Treatment of Prostate Cancer

    {{header-clinical-trials-navigation}}

    Focal Prostate Radio-Frequency Ablation for the Treatment of Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02328807

    Sponsor: H. Lee Moffitt Cancer Center and Research Institute

    Eligibility:

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

    Inclusion Criteria:

    • Men 18 years of age or older
    • Diagnosis of adenocarcinoma of the prostate, confirmed by H.L. Moffitt Cancer Center review
    • No prior treatment for prostate cancer
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or1
    • Prostate Cancer Clinical Stage T2a and below
    • PSA <10 ng/ml (this will be the prostatic specific antigen (PSA) level prompting the initial prostate biopsy)
    • Prostate size <60 cc on transrectal ultrasound
    • Pre-enrollment biopsy parameters (as per H.L. Moffitt C.C. review): Minimum of 10 biopsy cores; Gleason score 6 aor 7; Unilateral cancer (only right-sided or left-sided, not bilateral).

    Exclusion Criteria:

    • Men less than 18 years of age
    • Medically unfit for anesthesia
    • Histology other than adenocarcinoma
    • Biopsy does not meet inclusion criteria
    • Men who have received any hormonal manipulation (antiandrogens; Luteinizing Hormone Releasing Hormone (LHRH) agonist; 5-alpha-reductase inhibitors) within the previous 6 months

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published January 10, 2017
  • Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR): A Randomized Multi-center Study for Men With Newly Diagnosed Favorable Risk Prostate Cancer

    {{header-clinical-trials-navigation}}

    Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR): A Randomized Multi-center Study for Men With Newly Diagnosed Favorable Risk Prostate Cancer


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT04396808

    Sponsor: University of Michigan Rogel Cancer Center

    Eligibility:

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

    Inclusion Criteria:

    • Prostate cancer patients who have undergone diagnostic prostate biopsy in the past 9 months.
    • Prostate biopsy tumor tissue (FFPR block) available for processing
    • Age 18 years or older
    • PSA <20 ng/ml
    • Grade Group (GG) 1 cancer with > 2 biopsy cores involved with cancer OR GG2 cancer
    • Ability to understand and the willingness to sign a written informed consent. A subject's legally acceptable representative may sign the consent form.

    Exclusion Criteria:

    • Clinical (on digital rectal exam) or radiographic evidence (if MRI performed) of T3 disease
    • Nodal or metastatic prostate cancer (if staging imaging performed)
    • Prior prostate cancer treatment, including prostatectomy, radiation therapy, or hormone therapy.
    • Prior prostate gene expression classier testing

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published November 27, 2023
  • Germline Alterations of Tumor Susceptibility Genes in New York Cancer Patients

    {{header-clinical-trials-navigation}}

    Germline Alterations of Tumor Susceptibility Genes in New York Cancer Patients


    Condition: Breast Cancer, Bladder Cancer, Kidney Cancer, Colon Cancer, Prostate Cancer, Lung Cancer, Ovarian Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT00579514

    Sponsor: Memorial Sloan Kettering Cancer Center

    Eligibility:

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

    Inclusion Criteria:

    • Patients with a histologic diagnosis of cancer of the colon, breast, bladder, kidney, testicles, lungs, prostate, head and neck, or lymphoid organs, who have donated a diagnostic blood sample as either an inpatient or outpatient at MSKCC.
    • All patients who have two or more histologic diagnoses of the same primary tumor type involving the above sites.
    • Patients of Ashkenazi Jewish ancestry with a histologic diagnosis of cancer of any type.
    • Samples ascertained as part of protocol 98-024A(1) are also eligible for ascertainment in this study.

    Exclusion Criteria:

    • MSKCC patients without a histologic diagnosis of cancer of the breast, bladder, kidney, colon, testicles, lungs, prostate, or lymphoid malignancy (including all types of lymphoma) will not be eligible for the AMDeC sponsored component of the study.

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published March 5, 2017
  • HDR Monotherapy for Prostate Cancer: A Feasibility Study of Focal Radiotherapy Yields

    {{header-clinical-trials-navigation}}

    HDR Monotherapy for Prostate Cancer: A Feasibility Study of Focal Radiotherapy Yields


    Condition: Prostate Cancer

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02918253

    Sponsor: University Health Network, Toronto

    Eligibility:

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

    Inclusion Criteria:

    • Age ≥ 18 years
    • ECOG performance status 0
    • 2
    • Histological evidence of prostate adenocarcinoma
    • Low- and favorable intermediate-risk prostate cancer
    • Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed
    • No contraindications to MRI:
    • Absent or unifocal intraprostatic disease (<2 separate/distinct lesions), on multiparametric MRI
    • Prostate gland size <80cc
    • Baseline IPSS <18
    • No TRUP within the past 6 months, nor large TURP defect
    • Absence of radiological evidence of regional or distant metastases (optional evaluation, at physician discretion)
    • No previous pelvic and/or prostate EBRT and/or brachytherapy
    • No contraindications to general anesthesia, or spinal/epidural anesthesia
    • Absence of bleeding diathesis and/or anti-coagulative therapy that cannot be temporarily ceased during brachytherapy
    • No contraindications to endorectal coil, surgically absent rectum, severe hemorrhoids or colorectal surgery
    • Negative past medical history of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or SLE
    • Absence of latex allergy
    • No other medical conditions deemed by the PI to make patient ineligible for prostate HDR brachytherapy

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2017
  • Hereditary Leiomyomatosis Renal Cell Cancer (HLRCC): Identification of the Disease Gene and Characterization of the Predisposition to Renal Cancer

    {{header-clinical-trials-navigation}}

    Hereditary Leiomyomatosis Renal Cell Cancer (HLRCC): Identification of the Disease Gene, and Characterization of the Predisposition to Renal Cancer


    Condition: Renal Tumor Histology, Cutaneous Leiomyoma, Kidney Cancer

    Study Type: Observational

    Clinical Trials Identifier NCT 8-digits: NCT00050752

    Sponsor: National Cancer Institute (NCI)

    Phase:

    Eligibility:

    • Age: minimum 2 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • Patients suspected or known to have phenotype or genotype suggestive of Hereditary Leiomyomatosis and Renal Cell Cancer Syndrome (HLRCC), such as:
    • Cutaneous leiomyoma and kidney cancer
    • Cutaneous leiomyoma and uterine leiomyoma
    • Multiple cutaneous leiomyoma
    • Kidney cancer and uterine leiomyomata
    • Renal tumor histology consistent with HRLRCC including, but not limited to: Collecting Duct and/or Papillary, Type II
    • All patients and parents/guardians, for children younger than 18 years of age, must sign an informed consent document indicating their understanding of the investigational nature and the risks of this study before any protocol related studies are performed. Patients under the age of 18 but who are age 13 or older will be asked to sign an assent document prior to participation.
    • Participants must be >= 2 years of age.
    • A relative (related by blood) of a patient with a confirmed or suspected diagnosis of HLRCC.

    Exclusion Criteria:

    1. None

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 29, 2017

Page 2 of 5