Prostate Cancer

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Observational Study of Immune Responses in Prostate, Lung, Melanoma and Breast Cancer Patients Following Stereotactic Body Radiotherapy (SBRT), Intensity Modulated Radiotherapy (IMRT) or Brachytherapy


Condition: Prostate Cancer, Breast Cancer, Lung Cancer, Melanoma

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT01777802

Sponsor: Mayo Clinic

Phase:

Eligibility:

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

Inclusion Criteria:

  • Hormone Refractory, Metastatic Prostate Cancer, Lung Cancer, and Melanoma or Breast Cancer

Exclusion Criteria:

  1. -Life expectancy of less than 3 months

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A Randomized, Double-Blind, Placebo-Controlled Trial of Metformin in Reducing Progression Among Men on Expectant Management for Low Risk Prostate Cancer: The MAST (Metformin Active Surveillance Trial) Study


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01864096

Sponsor: University Health Network, Toronto

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum 79 Years
  • Gender: Male

Inclusion Criteria:

  1. Must be male > 18 and < 80 years of age
  2. Have biopsy proven, low-risk, localized prostate cancer choosing expectant management as primary treatment ≤ 1year. [For the purposes of assessing subject eligibility a diagnostic biopsy must have included at least 10 cores, ≤1/3 of total number of cores sampled and < 50% of any one core positive) and must have been obtained within 6 months of screening]. Initial diagnosis of T1a/T1b obtained during a TURP is not allowed
  3. Gleason score ≤ 6 [Gleason pattern 4 or above must not be present on any biopsy (initial or entry)]
  4. Clinical stage T1c-T2a
  5. Serum PSA ≤10 ng/mL (prior to biopsy)
  6. Life expectancy greater than 5 years, as judged by the treating clinician/urologist
  7. Able to swallow and retain oral medication
  8. Hemoglobin A1c < 6.5%
  9. Able and willing to participate in the full 3 years of the study
  10. Able to understand instructions related to study procedures
  11. Able to read and write (health outcome questionnaires are self-administered), understand instructions related to study procedures and give written informed consent

Exclusion Criteria:

  • 1. Subject that has ever been treated for prostate cancer with any of the following:
  • Radiotherapy (external beam or brachytherapy)
  • Chemotherapy
  • Hormonal therapy (e.g., megestrol, medoxyprogesterone, cyproterone)
  • Oral glucocorticoids
  • GnRH analogues (e.g., leuprolide, goserelin, degarelix) 2. Current and/or previous use of the following medications:
  • Use of 5α-reductase inhibitors (eg. Finasteride, Dutasteride) within the past 6 months of screening
  • Drugs with antiandrogenic properties (e.g., flutamide, bicalutamide, ketoconazole, progestational agents) within 6 months prior to screening 3. Previous or current diagnosis of type 1 or type 2 diabetes 4. Exposure to metformin within 12 months of screening 5. Planned or concurrent use of metformin hydrochloride, sulfonylureas, thiazolidinediones, or insulin for any reason 6. Known hypersensitivity or intolerance to metformin hydrochloride 7. Any condition associated with increased risk of metformin hydrochloride-associated lactic acidosis (e.g. congestive heart failure defines as NYHA class III or IV, history of any type of acidosis, habitual intake of ≥ 4 alcoholic beverages per day) 8. Subject has had prior prostatic surgery including TUNA, TURP, TUIP, laser treatment, thermotherapy, balloon dilatation, prosthesis, and ultrasound ablation within 3 months of screening 9. Participation in any investigational or marketed drug trial within 30 days prior to screening or anytime during the study period. This includes any interventional or exercise trials 10. Any unstable serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit 11. Abnormal liver function test:
  • Total bilirubin > 1.8 X institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) > 1.8 X institutional ULN
  • Alanine aminotransferase (ALT) > 1.8 X institutional ULN
  • Alkaline phosphatase (ALP) > 1.8 X institutional ULN 12. Serum creatinine > 1.8 X ULN 13. History of other malignancies, with the exception of adequately treated nonmelanoma skin cancer, stage I melanoma, NMIBC or other solid tumors curatively treated with no evidence of disease for at least 5 years 14. History or current evidence of substance abuse, as defined in DSM-IV, within 12 months of screening 15. History of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject 16. No other concurrent metformin hydrochloride, sulfonylureas, thiazolidinediones, or insulin for any reason

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Phase I-II Study HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer With or Without Metastatic Disease


Condition: Prostatic Neoplasms

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01913106

Sponsor: The Methodist Hospital System

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  • biopsy-proven local recurrence of prostate cancer without metastatic disease after the hormone therapy at least 2 year after the completion of definitive radiation therapy
  • Zubrod performance status 0-1
  • WBC ≥ 4,000/μl, platelets ≥ 100,000/μl
  • hemoglobin ≥ 8.5 mg/dl
  • normal partial thromboplastin time and prothrombin time
  • bilirubin < 1.5 mg/dl, and AST and alanine aminotransferase < 2.5 times the upper limit of normal
  • Serum creatinine ≤ 1.6 mg/dl
  • Must undergo pre-treatment evaluation of tumor extent and tumor measurement
  • Nutritional and general physical condition must be considered compatible with the proposed radio-therapeutic treatment
  • Not on any other experimental therapeutic cancer treatment
  • No active untreated infection
  • No major medical or psychiatric illness
  • International Prostate Symptom Score (IPSS) less than 15
  • Signed study-specific consent form prior to study entry
  • Prostate volume less than 50 cc
  • PSA > 10ng/ml within the past 3 months may enter study

Exclusion Criteria:

  • Symptomatic metastasis disease
  • Patients with a life expectancy < 10 years
  • Patients on corticosteroids or any immunosuppressive drugs.
  • HIV + patients
  • Patients with acute infections (viral, bacterial, or fungal infections requiring therapy)
  • Patients with cirrhosis.
  • Patients with collagen vascular diseases
  • International Prostate Symptom Score (IPSS) greater than 15
  • Prostate volume greater than 50 cc
  • Second active cancer except cutaneous cancer
  • Patients with history of allergies to valacyclovir, acyclovier or who cannot take oral pills

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MRI-Guided HDR Brachytherapy for Prostate Cancer


Condition: Patients With Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT00913939

Sponsor: University Health Network, Toronto

Eligibility:

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

Inclusion Criteria:

  • Prior enrollment of UHN 05-0641-C or UHN 12-5015-C (Arm 1)
  • Histological evidence of recurrent prostate adenocarcinoma (Arm 1)
  • PSA doubling time > 6 months (Arm 1)
  • High-risk localized prostate cancer (>T2 or G>7 or PSA>20) (Arm 2)
  • Planned for EBRT + HDR boost (+/- hormone therapy) (Arm 2)
  • ECOG 0 or 1
  • Age > 18 years
  • 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.

Exclusion Criteria:

  • Radiological evidence of regional or distant metastases
  • Contraindications to MRI (Patient weighing >136kg (scanner weight limit), Patients with pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic devices not compatible with MRI)
  • Bleeding diathesis and anti-coagulative therapy that cannot be temporarily ceased during brachytherapy
  • Previous prostate brachytherapy
  • Active hormonal therapy (Arm 1) ->50% of contiguous sextants involved with tumor (Arm 1)
  • Previous pelvic radiotherapy (Arm 2)
  • Contraindications to endorectal coil, surgically absent rectum, severe hemorrhoids or colorectal surgery.
  • Latex Allergy
  • Contraindications to conscious sedation, local anesthesia, or spinal/epidural anesthesia.
  • IPSS >18
  • Large TURP defect
  • TURP within the past 6 months
  • Prostate gland size >80cc
  • History of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or SLE
  • Other medical conditions deemed by the PI to make patient ineligible for MRI-guided Prostate HDR brachytherapy.

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STAMPEDE: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: A Multi-Stage Multi-Arm Randomised Controlled Trial


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT00268476

Sponsor: Medical Research Council

Phase: Phase 2/Phase 3

Eligibility:

  • Age: minimum N/A maximum 120 Years
  • Gender: Male

Inclusion Criteria:

  • Participants must fulfil all the criteria in one of the following three categories. Additionally, all patients must fulfil the criteria in Section 4. 1. High-Risk Newly-Diagnosed Non-Metastatic Node-Negative (N0/Nx) Disease Both: • At least two of: T category T3/4, PSA≥40ng/ml or Gleason sum score 8-10 • Intention to treat with radical radiotherapy (unless there is a contra-indication) OR 2. Newly-Diagnosed Metastatic Or Node-Positive Disease At least one of:
  • Stage Tany N+ M0
  • Stage Tany Nany M+ OR 3. Previously Radically Treated, Now Relapsing (Prior Radical Surgery And/or Radiotherapy) At least one of: • PSA ≥4ng/ml and rising with doubling time less than 6 months • PSA ≥20ng/ml • N+ • M+ AND 4. General Inclusion Criteria Required For All Participants 1. Histologically confirmed prostate adenocarcinoma 2. Intention to treat with long-term androgen deprivation therapy 3. Fit for all protocol treatment and follow up, WHO performance status 0-2 4. Have completed the appropriate investigations prior to randomisation 5. Adequate haematological function: neutrophil count ≥1.5x109/l and platelets ≥100x109/l 6. Adequate renal function, defined as GFR ≥30ml/min/1.73m2 7. Written informed consent 8. Willing and expected to comply with follow up schedule 9. Using effective contraceptive method if applicable 1. Medical contraindications to the trial medications are given in Section 6 2. For WHO performance status definitions see Appendix A 5. General Exclusion Criteria Patients must not fulfil any of the criteria below: 1. Prior systemic therapy for locally-advanced or metastatic prostate cancer (1) (except as listed in the protocol section 4.3) 2. Prior exposure to hormone therapy for a duration of > 12 months, or prior exposure completing < 12 months before randomisation (see section 4.3.1 for permitted prior exposure details) 3. Metastatic brain disease or leptomeningeal disease 4. Abnormal liver functions consisting of any of the following: • Serum bilirubin ≥1.5 x ULN (except for patients with Gilbert's disease, for whom the upper limit of serum bilirubin is 51.3μmol/l or 3mg/dl) • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 x ULN
  • site must indicate at randomisation whether one or both tests are performed at site. Where both results are available both must confirm eligibility. 5. Any other previous or current malignant disease which, in the judgement of the responsible clinician, is likely to interfere with STAMPEDE treatment or assessment 6. Any surgical wound (e.g. TURP) which in the judgement of the responsible clinician may interfere with or be exacerbated by protocol treatment 7. Participant with significant cardiovascular disease, including: • Severe/unstable angina • Myocardial infarction less than 6 months prior to randomisation • Arterial thrombotic events less than 6 months prior to randomisation • Clinically significant cardiac failure requiring treatment, defined as New York Heart Association (NYHA) class II or above (1) • Cerebrovascular disease (e.g. stroke or transient ischaemic episode) less than 6 months prior to randomisation
  • Any other significant cardiovascular disease that in the investigator's opinion means the participant is unfit for any of the study treatments. 1. Excluding participants receiving docetaxel as part of SOC 2. NYHA classifications can be found in Appendix A 6. Comparison-specific eligibility criteria In addition to the general inclusion and exclusion criteria, the following comparison-specific eligibility criteria apply. For Randomisation to the "Metformin Comparison" Please note from protocol v20 only patients willing to participate in the metabolic sub study should be randomised to the metformin comparison. The sub study will be conducted in a limited number of sites, see section 4.7.4 for further information. In addition to the general inclusion and general exclusion criteria the following comparison-specific inclusion criteria must be met to be eligible for randomisation to the "metformin comparison": • HbA1c <48mmol/mol (equivalent to <6.5%) (1) • Adequate renal function, defined as GFR ≥45ml/min/1.73m (except for Switzerland (2)) • No history of lactic acidosis or pre-disposing conditions
  • Not current or previous treatment with metformin
  • No contra-indications to metformin
  • No current or previous medication for treatment of diabetes
  • Willingness to join the metabolic sub study The method used to determine glomerular filtration rate may vary according to local practice. Equations that either estimate glomerular filtration rate (eGFR) or creatinine clearance (CrCl) may be used and the same threshold value applies. Where possible, HbA1c should be performed prior to commencing SOC docetaxel to reduce the likelihood of corticosteroid-related hyperglycaemia impacting on eligibility. All participants with abnormal baseline HbA1c (i.e. 6.5% or higher) should be informed and referred to their GP for further management. (2) Except Switzerland, please refer to SAKK appendix for local guidance For Randomisation To The "Transdermal Oestradiol Comparison" In addition to the general inclusion and

Exclusion Criteria:

  • Patients must not fulfil any of the criteria below: 1. Prior systemic therapy for locally-advanced or metastatic prostate cancer (1) (except as listed in the protocol section 4.3) 2. Prior exposure to hormone therapy for a duration of > 12 months, or prior exposure completing < 12 months before randomisation (see section 4.3.1 for permitted prior exposure details) 3. Metastatic brain disease or leptomeningeal disease 4. Abnormal liver functions consisting of any of the following: • Serum bilirubin ≥1.5 x ULN (except for patients with Gilbert's disease, for whom the upper limit of serum bilirubin is 51.3μmol/l or 3mg/dl) • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 x ULN
  • site must indicate at randomisation whether one or both tests are performed at site. Where both results are available both must confirm eligibility. 5. Any other previous or current malignant disease which, in the judgement of the responsible clinician, is likely to interfere with STAMPEDE treatment or assessment 6. Any surgical wound (e.g. TURP) which in the judgement of the responsible clinician may interfere with or be exacerbated by protocol treatment 7. Participant with significant cardiovascular disease, including: • Severe/unstable angina • Myocardial infarction less than 6 months prior to randomisation • Arterial thrombotic events less than 6 months prior to randomisation • Clinically significant cardiac failure requiring treatment, defined as New York Heart Association (NYHA) class II or above (1) • Cerebrovascular disease (e.g. stroke or transient ischaemic episode) less than 6 months prior to randomisation
  • Any other significant cardiovascular disease that in the investigator's opinion means the participant is unfit for any of the study treatments. 1. Excluding participants receiving docetaxel as part of SOC 2. NYHA classifications can be found in Appendix A 6. Comparison-specific eligibility criteria In addition to the general inclusion and exclusion criteria, the following comparison-specific

Eligibility Criteria:

  • In addition to the general inclusion and exclusion criteria, the following comparison-specific eligibility criteria apply. For Randomisation to the "Metformin Comparison" Please note from protocol v20 only patients willing to participate in the metabolic sub study should be randomised to the metformin comparison. The sub study will be conducted in a limited number of sites, see section 4.7.4 for further information. In addition to the general inclusion and general exclusion criteria the following comparison-specific inclusion criteria must be met to be eligible for randomisation to the "metformin comparison": • HbA1c <48mmol/mol (equivalent to <6.5%) (1) • Adequate renal function, defined as GFR ≥45ml/min/1.73m (except for Switzerland (2)) • No history of lactic acidosis or pre-disposing conditions
  • Not current or previous treatment with metformin
  • No contra-indications to metformin
  • No current or previous medication for treatment of diabetes
  • Willingness to join the metabolic sub study The method used to determine glomerular filtration rate may vary according to local practice. Equations that either estimate glomerular filtration rate (eGFR) or creatinine clearance (CrCl) may be used and the same threshold value applies. Where possible, HbA1c should be performed prior to commencing SOC docetaxel to reduce the likelihood of corticosteroid-related hyperglycaemia impacting on eligibility. All participants with abnormal baseline HbA1c (i.e. 6.5% or higher) should be informed and referred to their GP for further management. (2) Except Switzerland, please refer to SAKK appendix for local guidance For Randomisation To The "Transdermal Oestradiol Comparison" In addition to the general inclusion and exclusion criteria, participants fulfilling all of the following are eligible for the "transdermal oestradiol comparison": • ≤8 weeks of anti-androgen (AR-antagonists) use • Maximum of 1 dose of monthly or 4-weekly LHRH agonist/antagonist • No prior LHRH agonist injection with a stated duration of effect greater than 1 month • ≤12 weeks since first dose of any hormone therapy • Not had a bilateral orchidectomy • No use of cyproterone acetate (36) prior to randomisation • No known porphyria
  • No known history of deep vein thrombosis or pulmonary embolism confirmed radiologically
  • No known thrombophilic disorder (e.g. Protein C, Protein S, antithrombin deficiency)
  • Not yet started SOC abiraterone, enzalutamide or apalutamide

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A Randomized-Controlled Trial of Transcutaneous Oestrogen Patches Versus LHRH Agonists in Prostate Cancer


Condition: Anemia, Cardiovascular Complications, Hot Flashes, Osteoporosis, Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT00303784

Sponsor: University College, London

Phase: Phase 3

Eligibility:

  • Age: minimum N/A maximum 120 Years
  • Gender: Male

Disease Characteristics:

  • Must meet 1 of the following criteria:
  • Newly diagnosed patients with any of the following:
  • Stage T3 or T4, NX, M0 histologically confirmed prostate adenocarcinoma with prostate-specific antigen (PSA) ≥ 20 ng/mL or Gleason score ≥ 6
  • Any T, N+, M0, or any T, any N, M+ histologically confirmed prostate adenocarcinoma
  • Multiple sclerotic bone metastases with a PSA ≥ 50 ng/mL without histological confirmation
  • Patients with histologically confirmed prostate adenocarcinoma previously treated with radical surgery or radiotherapy who are currently in relapse with on of the following:
  • PSA ≥ 4 ng/mL and rising with doubling time less than 6 months
  • PSA ≥ 20 ng/mL
  • Must have written informed consent
  • Intention to treat with long-term androgen-deprivation therapy
  • Normal testosterone level prior to hormonal treatment

Patient Characteristics:

  • WHO performance status 0-2
  • No other prior or current malignant disease or cardiovascular system disease that is likely to interfere with study treatment or assessment
  • No cardiovascular disease, including any of the following:
  • History of cerebral ischemia (e.g., stroke or transient ischemic attack) within the past 2 years
  • History of deep vein thrombosis or pulmonary embolism confirmed radiologically
  • History of myocardial infarction (MI) within the past 6 months OR MI more than 6 months ago with evidence of q-wave anterior infarct on ECG
  • ECHO or MUGA required for patients with history of ischemic heart disease
  • Left Ventricular Ejection Fraction ≤ 40%
  • No condition or situation that could preclude protocol treatment or compliance with follow-up schedule

Prior Concurrent Therapy:

  • See Disease Characteristics
  • At least 12 months since prior adjuvant or neoadjuvant hormonal therapy for localized prostate cancer AND therapy lasted ≤ 12 months in duration
  • No prior systemic therapy for locally advanced or metastatic prostate cancer
  • No concurrent participation in another clinical trial of prostate cancer treatment that would preclude study therapy or outcome measures
  • Concurrent prophylactic radiotherapy to prevent gynecomastia allowed

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Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)


Condition: Metastatic Castration-Resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02861573

Sponsor: Merck Sharp & Dohme LLC

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  • For Cohorts A, B, C, D, E, G: Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
  • For Cohorts F, H, I: Has t-NE or de novo metastatic prostate cancer defined by ≥1% neuroendocrine cells that are located in discrete regions of a recent biopsy specimen from a metastasis as determined by the investigational site and confirmed by central histology review prior to enrollment
  • Is able to provide tumor tissue from a site not previously irradiated as follows: Cohorts A, E, and G: must provide a core or excisional biopsy from soft tissue or bone biopsy within 1 year of screening and after developing mCRPC; Cohort B: must provide an archival tumor tissue sample or tumor tissue from a newly obtained core or excisional biopsy from soft tissue if the lesion is clinically accessible; Cohorts C and D with soft tissue disease: must provide a core or excisional biopsy from a soft tissue lesion if clinically accessible within 1 year of screening and after developing mCRPC and an archival specimen if available; and Cohorts F, H, and I must provide a core or excisional biopsy from soft tissue or a bone biopsy. For de novo metastatic neuroendocrine prostate participants, biopsies must be performed within 1 year of screening. Participants with bone metastasis only must provide an archival tumor tissue specimen.
  • Has prostate cancer progression within 6 months prior to screening, as determined by the investigator, by means of one of the following: PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL; radiographic disease progression in soft tissue based on Response Evaluation Criteria In Solid Tumors Version 1.1 criteria with or without PSA progression; radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression. Participants with de novo neuroendocrine prostate cancer will not need to provide evidence of progression within 6 months
  • Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM). Treatment with luteinizing hormone-releasing hormone agonists or antagonists for all cohorts must have been initiated ≥4 weeks prior to first dose of study therapy and must be continued throughout the study. Participants with de novo metastatic NE prostate cancer will not be required to have been previously treated with androgen deprivation therapy (ADT). ADT must be started in these participants by the time of treatment allocation/randomization
  • Participants receiving bone resorptive therapy (including, but not limited to bisphosphonate or receptor activator of nuclear factor kappa-β ligand inhibitor) must be on stable doses for ≥4 weeks prior to first dose of study therapy
  • Must be abstinent from heterosexual intercourse, refrain from donating sperm, or agree to use contraception (unless confirmed to be azoospermic) during the intervention period starting with the first dose of study therapy. The length of time required to continue contraception after the last dose of study intervention for each study intervention is as follows: 7 days for abiraterone acetate and lenvatinib; 30 days for enzalutamide; and 95 days for olaparib, docetaxel, and carboplatin/etoposide. No contraception measures are required during and after the intervention period for pembrolizumab/vibostolimab coformulation.
  • Has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale for Cohorts A and C and a performance status of 0 or 1 for Cohorts B, D, E, F, G, H, and I within 10 days of study start
  • For Cohort A: Has received docetaxel for mCRPC. Prior treatment with 1 other chemotherapy for mCRPC is allowed. Up to 2 second-generation hormonal manipulations (e.g., abiraterone acetate and/or enzalutamide) are allowed. Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ≥4 weeks have elapsed from the last dose of docetaxel prior to day 1 of Cycle 1
  • For Cohort B: Has received prior treatment with either abiraterone acetate or enzalutamide (but not both) in the prechemotherapy mCRPC state. Participants in Cohort B must have received at least 4 weeks of either abiraterone or enzalutamide treatment (but not both) who failed treatment or became intolerant of the drug
  • For Cohort C: Has received prior treatment with abiraterone acetate in the pre-chemotherapy mCRPC state without prior enzalutamide. Participants in Cohort C must have received at least 4 weeks of abiraterone treatment who failed treatment or become intolerant of the drug. Participants who received abiraterone acetate in the hormone-sensitive state will not be eligible
  • For Cohort D: Has not received chemotherapy for mCRPC and has either not had prior second generation hormonal manipulation for mCRPC OR has previously been treated with enzalutamide for mCRPC and failed treatment or has become intolerant of the drug. Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ≥4 weeks have elapsed from the last dose of docetaxel. Prior treatment with abiraterone acetate in the hormone-sensitive metastatic setting is allowed as long as there was no progression on this agent and abiraterone acetate was not discontinued due to adverse events (AEs)
  • For Cohorts E and G: Has received docetaxel for mCRPC. Prior treatment with 1 other chemotherapy for mCRPC is allowed. Up to 2 second-generation hormonal manipulations (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide or other next-generation hormonal agents [NHA]) are allowed. Participants who received prior ketoconazole for metastatic disease may be enrolled. If docetaxel chemotherapy is used more than once (eg, once for metastatic hormone-sensitive and once for mCRPC), it will be considered as 1 therapy. Prior docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC) is allowed if ≥4 weeks have elapsed from the last dose of docetaxel prior to Day 1 of Cycle 1
  • For Cohort F, H, and I: Participants must have received prior treatment with androgen deprivation therapy (ADT) for metastatic disease. Participants must also have received prior treatment with an NHA (eg, abiraterone acetate, apalutamide, darolutamide, enzalutamide, or other NHA) or docetaxel for mHSPC or mCRPC. Prior treatment with up to a total of 2 chemotherapies for mCRPC is allowed, as well as up to 2 second-generation hormonal manipulations for mCRPC. Participants who received prior ketoconazole for metastatic disease may be enrolled. Docetaxel for mHSPC is allowed in addition to docetaxel for mCRPC. If docetaxel chemotherapy is used more than once (eg, once for metastatic hormone-sensitive and once for mCRPC), it will be considered as 1 therapy.

Exclusion Criteria:

  • Has had a prior anticancer monoclonal antibody (mAb) within 4 weeks prior to first dose study therapy or who has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to mAbs administered >4 weeks earlier
  • Has had prior chemotherapy, targeted small molecule therapy abiraterone treatment, enzalutamide treatment, or radiation therapy within 2 weeks prior to first dose of study therapy or who has not recovered (ie, Grade ≤1 or at baseline) from AEs due to a previously administered agent
  • Is currently participating in and receiving study therapy or has participated in a study of an investigational agent and received study drug or used an investigational device within 4 weeks of treatment allocation/randomization
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to treatment allocation/randomization
  • Has had prior treatment with therapeutic radiopharmaceuticals for prostate cancer, such as Radium-223 or Leutitium-177, within 4 weeks prior to the first dose of trial treatment
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease
  • Has previously participated in any other pembrolizumab trial, or received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), and anti-programmed cell death ligand 1 (anti-PD-L2)
  • Has a known history of Human Immunodeficiency Virus (HIV)
  • Has known active Hepatitis B or Hepatitis C
  • Has received a live vaccine or live-attenuated vaccine within 30 days of the first dose of study therapy. Any licensed COVID-19 vaccine (including for emergency use) in a particular country is allowed in the study as long as they are mRNA vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy. Investigational vaccines (ie, those not licensed or approved for emergency use) are not allowed
  • Has known active central nervous system metastases and/or carcinomatous meningitis
  • Has a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated
  • Has had prior solid, organ or bone marrow transplant
  • For Cohort A: Has experienced a seizure or seizures within 6 months of study start or is currently being treated with cytochrome P450 enzyme (CYP) inducing anti-epileptic drugs for seizures
  • For Cohort A: Is currently receiving strong or moderate inhibitors of CYP3A4 including azole antifungals; macrolide antibiotics; or protease inhibitors
  • For Cohort A: Is currently receiving strong or moderate inducers of CYP3A4
  • For Cohort A: Has myelodysplastic syndrome
  • For Cohort A: Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease), unstable angina pectoris, cardiac arrhythmia, or uncontrolled hypertension
  • For Cohort B: Has received prior treatment with docetaxel or another chemotherapy agent for metastatic prostate cancer
  • For Cohort B: Has peripheral neuropathy Common Terminology Criteria for Adverse Events ≥2 except due to trauma
  • For Cohort B: Has ascites and/or clinically significant pleural effusion
  • For Cohort B:Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease)
  • For Cohort B: Is currently receiving any of the following classes of inhibitors of CYP3A4: azole antifungals; macrolide antibiotics; or protease inhibitors
  • For Cohort C: Has received prior chemotherapy for mCRPC. Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ≥4 weeks elapsed from last dose of docetaxel. Participants who received abiraterone acetate in the hormone-sensitive state will not be eligible
  • For Cohort C: Has a history of seizure or any condition that may predispose to seizure (including, but not limited to prior cerebrovascular accident, transient ischemic attack, or brain arteriovenous malformation; or intracranial masses such as a schwannoma or meningioma that is causing edema or mass effect)
  • For Cohort C:Has known or suspected brain metastasis or leptomeningeal carcinomatosis
  • For Cohort C: Has a history of loss of consciousness within 12 months of the screening visit
  • For Cohort C: Has hypotension (systolic blood pressure <86 millimeters of mercury [mmHg]) or uncontrolled hypertension (systolic blood pressure >170 mmHg or diastolic blood pressure >105 mmHg) at the screening visit
  • For Cohort C: Has received treatment with 5-α reductase inhibitors (e.g., finasteride, dutasteride), estrogens, and/or cyproterone within 4 weeks prior to Cycle 1
  • For Cohort C: Has a history of prostate cancer progression on ketoconazole
  • For Cohort D: Has received prior treatment with docetaxel or another chemotherapy agent for metastatic prostate cancer
  • For Cohort D: Has progressed on prior abiraterone acetate for treatment of castration sensitive or resistant metastatic prostate cancer
  • For Cohort D: Has discontinued prior treatment with abiraterone acetate due to AEs
  • For Cohort D: Has previously been treated with ketoconazole for prostate cancer for >7 days
  • For Cohort D: Has received prior systemic treatment with an azole drug (eg, fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1
  • For Cohort D: Has uncontrolled hypertension (systolic BP ≥ 160 mm Hg or diastolic BP ≥ 95 mm Hg)
  • For Cohort D: Has a history of pituitary or adrenal dysfunction
  • For Cohort D: Has clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association Class II-IV heart disease or cardiac ejection fraction measurement of <50% at baseline
  • For Cohort D: Has atrial fibrillation, or other cardiac arrhythmia requiring therapy
  • For Cohort D: Has a history of chronic liver disease
  • For Cohort D: Is currently receiving strong CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) during abiraterone acetate treatment, CYP2D6 substrates with a narrow therapeutic index (for example thioridazine), or CYP2C8 substrates with a narrow therapeutic index (for example pioglitazone)
  • For Cohorts E and F: Has a left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO)
  • For Cohorts E and F: Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
  • For Cohorts E and F: Has prolongation of QT interval by Fredericia (QTcF) interval to >480 milliseconds
  • For Cohorts E and F: Has had major surgery within 3 weeks prior to first dose of study interventions
  • For Cohorts E and F: Has pre-existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
  • For Cohorts E and F: Has had significant cardiovascular impairment within 12 months of the first dose of study intervention, such as history of New York Heart Association >Class II congestive heart failure, unstable angina, myocardial infarction, or cerebrovascular accident (CVA)/stroke, cardiac revascularization procedure, or cardiac arrhythmia associated with hemodynamic instability
  • For Cohorts E and F: Has active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of lenvatinib
  • For Cohorts E and F: Has gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib
  • For Cohorts G, H, and I: Has had a severe hypersensitivity reaction to treatment with another monoclonal antibody
  • For Cohorts G, H, and I: Has symptomatic ascites or pleural effusion
  • For Cohort I: Has clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, and/or abdominal carcinomatosis
  • For Cohort I: Has received previous treatment for prostate cancer with platinum-containing compounds

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Primary Radical Prostatectomy Versus Primary Radiotherapy for Locally Advanced Prostate Cancer: an Open Randomized Clinical Trial


Condition: Prostatic Neoplasms

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02102477

Sponsor: Olof Akre

Eligibility:

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

Inclusion Criteria:

  • Age ≤75, at the time of randomization
  • Diagnosed histopathologically confirmed and untreated prostatic adenocarcinoma
  • The general condition and mental status of patients shall permit observation in accordance with the study protocol
  • Tumor stage (T, M, N): T3 stage (as indicated by digital rectal examination or MR imaging or other validated imaging technique) T4 tumors can be included if considered resectable/treatable on MR imaging Significant extra-capsular tumor extension in biopsy (rare but acceptable for inclusion) M0 (no sign of distant metastases) confirmed by bone scan or CT or MRT of axial skeleton (at a maximum of pelvis and lumbar vertebral column) N0 stage, defined in accordance to the RECIST guidelines as no sign of macroscopic retroperitoneal lymph-node metastases >=1.5 cm (short axis) on CT scan, PET-CT, or MRT or more than one suspected lymph-node metastases Presence Gleason grade pattern 4 or 5
  • Signed Informed consent

Exclusion Criteria:

  • Patients with a PSA value of > 100 ng/mL
  • Any medical condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives Patients with contraindications for either prostatectomy or radiotherapy to the prostate are not eligible for the study. Most contraindications for these treatments are relative, but in general, radiotherapy may be precluded among patients with:
  • Anorectal disease, such as fistulae, Crohn´s disease, and ulcerative colitis
  • Significant obstructive lower urinary tract symptoms
  • Proximal stricture of the urethrae
  • Severe neurogenic bladder dysfunction
  • Enlarged prostate beyond 70-90 ml
  • Previous radiotherapy to the pelvic region On the other hand, surgery may be precluded among patients with:
  • Massive local tumor progression, particularly in the apical region
  • Massive abdominal obesity
  • Contraindications to anesthesia

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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

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Phase II Study of Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate for Treatment of Localized, Non-Metastatic, High Risk Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01508390

Sponsor: Boston Medical Center

Eligibility:

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

Inclusion Criteria:

  • 1. Histologically proven adenocarcinoma of the prostate 1. Gleason score (2-10) 2. Biopsy within six months of date of registration 3. Patient age >18 years 2. Clinical stage (American Joint Committee on Cancer 7th Edition) a. T-stage determined by physical exam (Digital Rectal Exam Required) i. MRI findings (e.g. extracapsular extension) can be used to determine T-staging b. N-stage determined using abdominopelvic CT scan and/or MRI c. M-stage determined by physical exam, CT and/or MRI, and bone scan (must be M0, excepting Lymph nodes) Please note: a SPECT bone scan including a CT of the abdomen and pelvis or an F18 Fluciclovine PET/CT fulfills protocol criteria for both the abdominopelvic CT and bone scan. 3. Patients must belong to one of the following risk groups:
  • PSA > 20 and < 150 and/or
  • Gleason 8-10 and/or
  • > clinical T3a and/or
  • Clinical N1 OR
  • PSA 10
  • 20 AND
  • Gleason 7 AND
  • Clinical T2b
  • T2c 4. Patient is receiving, or planning to receive standard androgen deprivation therapy and initial IMRT to the prostate and positive or at-risk lymph nodes. 5. Prostate volume greater than 20 cc and less than 100 cc 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 7. Patient has agreed to complete questionnaires 8. Signed IRB approved informed consent 9. Patient eligible to have an MRI 10. Must be able to tolerate the confinement of an MRI procedure

Exclusion Criteria:

  1. No prior prostate surgery (including TURP) or prostate cancer treatment with the exception of androgen deprivation therapy
  2. No prior radiotherapy to the pelvis
  3. No implanted hardware (including metal) or other material that would prohibit appropriate treatment planning or treatment delivery
  4. No metastatic disease, with the exception of lymph node positive disease
  5. No chemotherapy for a malignancy in the last 5 years.
  6. No history of an invasive malignancy (other than basal or squamous skin cancers) in the last 5 years.
  7. No heart pacemaker, No metallic foreign body (metal sliver) in the eye, No aneurysm clip in the brain
  8. No history of a pelvic or horseshoe kidney
  9. No diagnosis of inflammatory bowel disease

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Safety and Early Efficacy of Radical Prostatectomy for Newly Diagnosed Very High Risk Locally Advanced and Oligometastatic Prostate Cancer - a Prospective Single Center Phase I/II Study


Condition: Locally Advanced and Metastatic Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02971358

Sponsor: Medical University of Vienna

Eligibility:

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

Inclusion Criteria:

  • Adenocarcinoma of the prostate
  • Very high risk PCA (PSA ≥ 20 oder Gleason Score ≥ 8 oder ≥ cT3) and/or oligometastasierte PCA (T any N positive M any, oder T any N any M positive)
  • ≤5 bone metastasis
  • ≤75 years
  • Ability for informed consent
  • Clinically no infiltration into the rectum or pelvic wall
  • Clinically no visceral metastasis
  • Male, >18 Jahre
  • Fit for surgery
  • ECOG Performance Status 0 oder 1

Exclusion Criteria:

  • Male, < 18 Jahre
  • > 5 bone metastasis
  • > 75 years
  • No ability for informed consent
  • Clinically infiltration into the rectum or pelvic wall
  • Not fit for surgery
  • Clinically visceral metastasis

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Phase III Study of Image Guided Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Adenocarcinoma of the Prostate


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01492972

Sponsor: Proton Collaborative Group

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • Histologically confirmed prostate adenocarcinoma (within 365 days of randomization) at intermediate risk for reoccurrence determined by at least one of the following: Gleason Score 7, PSA > = 10 and < = 20, T stage T2b
  • T2c
  • Clinical stages T1-T2c N0 M0 as staged by the treating investigator. (AJCC Criteria 7th Ed.- appendix III).
  • Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range of 2-7. > 6 cores are strongly recommended.
  • PSA values < = 20 ng/ml within 90 days prior to randomization. Obtained prior to biopsy or at least 21 days after prostate biopsy.
  • ECOG performance status 0-1 (appendix II) assessed within 90 days of randomization.
  • Patients must sign IRB approved study specific informed consent.
  • Patients must complete all required pre-entry tests listed in section 4.0 within the specified time frames.
  • Patients must be able to start treatment within 56 days of randomization.
  • Patients must be at least 18 years old.
  • For brachytherapy, an IPSS ≤ 21, or ≤ 17 if patient is on medications to improve urination.
  • For brachytherapy, prostate volume must be less than 55cc prior to AS.

Exclusion Criteria:

  • Pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
  • Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.
  • Previous pelvic radiation for prostate cancer.
  • Previous androgen suppression therapy for prostate cancer.
  • Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
  • Prior systemic chemotherapy for prostate cancer.
  • History of proximal urethral stricture requiring dilatation.
  • Current and continuing anticoagulation with warfarin sodium (Coumadin), heparin, low- molecular weight heparin, Clopidogrel bisulfate (Plavix), or equivalent (unless it can be stopped to manage treatment related toxicity or to have a biopsy if needed).
  • Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study).
  • Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed).
  • History of myocardial infarction within the last 6 months.

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Prospective Evaluation of CyberKnife® as Monotherapy or Boost Stereotactic Body Radiotherapy for Intermediate or High Risk Localized Prostate Cancer


Condition: Prostate Adenocarcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01985828

Sponsor: Advocate Health Care

Eligibility:

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

Criteria: - Patient must be ≥ 18 years of age. - Histologically proven prostate adenocarcinoma - Gleason score 2-10 (reviewed by reference lab) - Biopsy within one year of date of registration - Clinical stage T1b-T4, N0-Nx, M0-Mx (AJCC 7th Edition) - T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI; see section 4.5) - M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases. - PSA ≤ 50 ng/ml, CBC, platelets, BUN, creatinine prior to treatment - Patients belonging in one of the following risk groups: - Intermediate: CS T2b-c and Gleason <6 and PSA ≤ 10, or CS T1b-T2b, and Gleason 7 and PSA ≤ 10 ng/ml, or Gleason <6 and PSA 11-20 ng/ml - High: CS T3-4, Gleason score >7and PSA<50 - Prostate volume: ≤ 100 cc - Determined using: volume = π/6 x length x height x width - Measurement from MRI, CT or ultrasound prior to registration. - ECOG performance status 0-1 - No prior prostatectomy or cryotherapy of the prostate - No prior radiotherapy to the prostate or lower pelvis - No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion. - No chemotherapy for a malignancy in the last 5 years. - No history of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.

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The UCLA ASCAP Project is an Observational, Longitudinal, and Open-ended Study Aimed at Establishing a Structured Program of Non-interventional Follow-up for Localized Prostate Cancer.


Condition: Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT00949819

Sponsor: Jonsson Comprehensive Cancer Center

Phase:

Eligibility:

  • Age: minimum 30 Years maximum 85 Years
  • Gender: Male

Inclusion Criteria:

  1. Histologically confirmed adenocarcinoma of the prostate.
  2. Clinically localized prostate cancer: T1-2, NX or N0, MX or M
  3. No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
  4. Patient has elected Active Surveillance as preferred management plan for prostate cancer.
  5. Patient consent has been obtained according to local Institutional Review Board .
  6. Patient is accessible and compliant for follow-up.

Exclusion Criteria:

  1. Unwillingness or inability to undergo serial prostate biopsy.
  2. Overall life expectancy less than 2 years
  3. Advanced prostate cancer

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Whole-Pelvic Radiotherapy With a Stereotactic Body Radiotherapy Boost and Long-Term Androgen Deprivation for Unfavorable-Intermediate and High Risk Localized Adenocarcinoma of the Prostate.


Condition: Adenocarcinoma of the Prostate

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02064036

Sponsor: University of California, Davis

Eligibility:

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

Inclusion Criteria:

  1. Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence
  2. History/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.
  3. Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MRI), (but not by nodal sampling, or dissection) within 90 days prior to registration.
  4. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 2.0 cm.
  5. No evidence of bone metastases (M0) on bone scan within 90 days prior to registration.
  6. Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis.
  7. Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 12 weeks (90 days) prior to registration.
  8. Study entry PSA should not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of hormonal therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days after discontinuation of dutasteride.
  9. Zubrod Performance Status 0-2
  10. Complete blood count (CBC)/differential obtained within 2 weeks (14 days) prior to registration on study, with adequate bone marrow function
  11. Patient must be able to provide study specific informed consent prior to study entry.

Exclusion Criteria:

  1. Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 2 years.
  2. Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
  3. Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
  4. Previous hormonal therapy
  5. Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation is ≤ 60 days prior to the date of registration.
  6. Use of finasteride within 30 days prior to registration
  7. Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration
  8. Previous or concurrent cytotoxic chemotherapy for prostate cancer; note that prior chemotherapy for a different cancer is allowable. See Section 3.2.
  9. Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields
  10. Severe, active co-morbidity including heart issues, infection and liver problems
  11. Patients who are sexually active and not willing/able to use medically acceptable forms of contraception
  12. Prior allergic reaction to the hormones involved in this protocol
  13. Patients status-post a negative lymph node dissection are not eligible

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


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02643667

Sponsor: Washington University School of Medicine

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Eligibility Criteria:

  1. with the exception of alopecia.

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