Prostate Cancer

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A Phase I/IIa Study Evaluating the Safety and Tolerability of Intratumoral Administration of ORCA-010 in Treatment-Naïve Patients With Localized Prostate Cancer.


Condition: Adenocarcinoma of the Prostate

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04097002

Sponsor: Orca Therapeutics B.V.

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Histologically confirmed adenocarcinoma of the prostate, which is localized to the prostate ( within 24 months of screening) 2. Absence of lymph node, bone or other metastases as determined by MRI and CT scan, Bone Scan or nano-MRI (≤3 months prior to first administration) 3. Men between 18 and 75 years inclusive 4. ECOG status 0 or 1 5. Ability to understand and willingness to sign informed consent 6. Adequate liver, renal and bone marrow function: AST & ALT < 2.5 x ULN, total bilirubin < 1.5 x ULN, Alkaline phosphatase < 3 x ULN, Serum creatinine < 1.5 x ULN, Haemoglobin > 9.0 g/dL (5.59 mmol/L), Platelet count > 100x10*9/L, Neutrophils > 1.5x10*9/L, INR < 1.5xULN 7. eGFR ≥ 30 mL/min, using the Cockcroft
  • Gault Equation: Creatinine Clearance = [{(140
  • age in years) x (weight in kg)} x 1.23] /serum Creatinine in Mmol/L

Exclusion Criteria:

  1. Tumor not accessible for injection
  2. Prior treatment of prostate cancer with radiation therapy or brachytherapy
  3. Prior use of chemotherapy/hormone therapy for treatment of cancer
  4. Target tumor adherent to a major vascular structure
  5. Participation in any investigational drug study within the last 12 months prior to first administration of ORCA-010
  6. Clinically significant active infection (viral or bacterial)
  7. Known immunosuppressive diseases (e.g. HIV, Hepatitis B and C)
  8. History of any other oncological malignancy, excluding basal cell carcinoma of the skin, in the past 5 years
  9. Not willing to refrain from sexual activities or use a double barrier contraceptive device (condom with foam or vaginal suppository, diaphragm with spermicide) after administration of ORCA-010 and until 42 days after the last ORCA-010 administration
  10. Severe obesity defined as Body Mass Index (BMI) > 30 kg/m2
  11. Positive for adenovirus in throat swap or serum as determined by PCR at screening
  12. Recent (within 3 months prior to enrolment in the study) history of alcohol abuse or other substances such as barbiturates, cannabinoids and amphetamines or a positive urine screen for drugs of abuse
  13. Use of medication known to have immunosuppressive effects, except topical/inhaled steroids under 10 mg/day prednisolone equivalent (See Appendix 7)
  14. Use of systemic antiviral medication within 3 months prior to enrolment in the study
  15. Use of any anti-coagulants/blood thinner except for ASA 81mg
  16. Any condition that in the opinion of the Investigator could interfere with the conduct of the study
  17. For Part B only: Subjects enrolled in Part A of the study

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A First-in-Human Study to Determine the Safety, Pharmacokinetics and Efficacy of KPG-121 When Administered With Enzalutamide, Abiraterone, or Apalutamide in Subjects With Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer


Condition: Castration-Resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03569280

Sponsor: Kangpu Biopharmaceuticals, Ltd.

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  1. Signed informed consent provided prior to any study-related procedure being performed;
  2. Able to swallow and retain orally administered medication;
  3. Male aged 18 years and older (adult, older adult) at the time consent is obtained;
  4. Histologically or cytologically confirmed diagnosis of prostate carcinoma;
  5. Men with either non-metastatic or metastatic CRPC are eligible;
  6. Completed at least 4 or more weeks of prior continuous therapy with fixed stable dose enzalutamide, abiraterone or apalutamide prior to initiating study treatment (for Part 1), or with fixed stable dose enzalutamide (for Part 2), with no change in dose for at least 2 weeks prior to screening;
  7. Serum testosterone level <50 ng/dL (<0.5 ng/mL, <7.0 nmol/L). Subjects may have ongoing androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) "super-agonist" or antagonist, and/or be surgically or medically castrated;
  8. ECOG performance status of 0 or 1;
  9. Adequate baseline organ function;
  10. Must have a QT interval corrected for heart rate according to Fridericia's formula (QTcF) <470 milliseconds (msec) or <480 msec with bundle branch block;
  11. Male subject with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from time of screening until 3 months after the last dose of study medication;
  12. Willing and able to comply with all protocol required visits and assessments.

Exclusion Criteria:

  1. Life expectancy less than 3 months;
  2. Discontinuation of bicalutamide or nilutamide in less than 6 weeks, and other antiandrogens in less than 4 weeks, prior to the start of study medication;
  3. Prior chemotherapy, radiation (limited radiotherapy to control bone pain is permitted), sipuleucel-T or other experimental immunotherapy less than 4 weeks prior to the start of study medication;
  4. Prior malignancy other than CRPC. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible;
  5. Screening blood counts with:
  6. absolute neutrophil count <1500/μL
  7. platelets <100,000/μL
  8. hemoglobin <9 g/dL;
  9. Screening chemistry test results with:
  10. alanine aminotransferase (ALT) and aspartate transaminase (AST) >2.5 × ULN
  11. total bilirubin >2 × ULN
  12. for the dose escalation cohort, creatinine clearance of <70 mL/min as determined by Cockcroft and Gault formula
  13. for the dose expansion cohort, subjects with creatinine clearance of <50 mL/min will be excluded (if kidneys are not working properly, there is a risk that KPG-121 may stay in the blood circulation longer than expected and may increase side-effects)
  14. albumin <2.8 g/dL;
  15. Uncontrolled hypothyroidism, or TSH >2.0 x ULN at screening. Subjects who are clinically euthyroid and on stable thyroid replacement therapy for 2 months prior to enrollment are allowed;
  16. Current use of or anticipated requirement during the study of prohibited medication(s), any investigational drug, other anti-cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, or hormone therapy other than for replacement), AR antagonists (e.g., bicalutamide, flutamide, nilutamide), 5-alpha reductase inhibitors (e.g., finasteride, dutasteride), androgens (e.g., testosterone, dihydroepiandrosterone), Herbal medication(s) that may affect PSA levels (e.g., saw palmetto), Other herbal medications including, but not limited to: St. John's wort, kava, ephedra (ma huang), gingko biloba, yohimbe and ginseng);
  17. Any unresolved ≥grade 2 (per CTCAE v5.0) toxicity from previous anti-cancer therapy at the time of enrollment, except for grade 2 alopecia, anemia (if hemoglobin is >9.0 g/dL) or neuropathy;
  18. Any ≥grade 2 hypophosphatemia (per CTCAE v5.0) at the time of enrollment;
  19. Serum calcium ≥grade 1 (per CTCAE v5.0) at time of enrollment, unless ionized calcium is within normal range;
  20. Presence of any clinically significant gastrointestinal (GI) abnormality or other condition(s) that may alter absorption such as malabsorption syndrome or major resection of the stomach or substantial portion of the small intestine;
  21. Active peptic ulcer disease or history of abdominal fistula, GI perforation, or intra abdominal abscess within 28 days prior to enrollment;
  22. Previous history of difficulty swallowing capsules;
  23. Known active infection requiring intravenous (IV) or oral anti-infective treatment or serious persistent infection within 14 days prior to the start of study medication;
  24. Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to the start of study medication;
  25. Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal or cardiac disease);
  26. History of seizure or any condition that may predispose subject to seizure (e.g., prior cortical stroke or significant brain trauma). History of loss of consciousness or transient ischemic attack within 12 months prior to the start of study medication;
  27. Poorly controlled hypertension (defined as systolic BP ≥150 mmHg) or diastolic BP >100 mmHg based on a mean of three measurements at approximately 2-minute intervals);
  28. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to enzalutamide or abiraterone or apalutamide or excipients. Allergy to acetaminophen or NSAIDs;
  29. History of impaired adrenal gland function (e.g., Addison's disease, Cushing's syndrome);
  30. History or evidence of cardiovascular risk including any of the following: Clinically significant ECG abnormalities including second degree (Type II) or third degree atrioventricular block; history of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, stenting, or bypass grafting within 6 months prior to enrollment, Class III or IV heart failure as defined by the New York Heart Association functional classification system, left ventricular ejection fraction (LVEF) below 45% at screening; known cardiac metastases;
  31. Anticoagulants used by subjects with a history of thromboembolic conditions within 6 months prior to enrollment. Note: Subjects receiving anticoagulants for atrial fibrillation are eligible for the study;
  32. Use of systemic glucocorticoid (e.g., prednisone, dexamethasone) within 14 days prior to the start of study medication;
  33. Serious concurrent medical condition including central nervous system disorders;
  34. Previous major surgery within 30 days prior to the start of study medication;
  35. Blood transfusion (including blood products) within 1 week of screening;
  36. Any condition that, in the opinion of the investigator, would impair the subject's ability to comply with study procedures.

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Validating the miR Scientific Sentinel™ Platform (Sentinel PCC4 Assay) in Men Undergoing Core Needle Biopsy Due to Suspicion of Prostate Cancer for Distinguishing Between no Cancer, Low-, Intermediate- and High-Risk Prostate Cancer


Condition: Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04100811

Sponsor: miR Scientific LLC

Phase:

Eligibility:

  • Age: minimum 45 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. Males ≥ 45 years old
  2. Males with clinical suspicion of prostate cancer, including but not limited to elevated PSA level, suspicious DRE, family history of prostate cancer, and/or germline mutation, who as a result undergo TRUS- or MRI-guided core-needle biopsy and PSA recording (for NCCN group label).
  3. Signed informed consent prior to initiation of any study-related procedures.
  4. The patient provided a voided urine sample within 30 days prior to biopsy being performed and prior to DRE (if any). This collection must be ≥ 1 hour after the last urination.

Exclusion Criteria:

  1. Persons previously diagnosed with prostate cancer.
  2. Persons who have previously undergone a 12 core or fusion biopsy in the last 12 months
  3. Persons who have had a DRE within 72 hours of the urine collection
  4. Persons incapable of providing informed consent.
  5. Persons presenting with clinical symptoms of urinary tract infection, including prostatitis at the time of enrollment.
  6. Persons with prior history of invasive treatment for benign prostatic hyperplasia within 3-6 months of study enrollment.
  7. Patients treated with a 5-alpha-reductase inhibitor, Saw Palmetto for BPH or male pattern baldness within 3 months of the urine collection.

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Using Breath,Cell Free DNA and Image Analysis to PRedIct Normal TissUe and Tumour Response During Prostate Cancer SBRT With RayPilot® Motion Management


Condition: Prostate Cancer, Radiotherapy Side Effects, Volatile Organic Compounds, DNA Damage

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04081428

Sponsor: NHS Lothian

Phase:

Eligibility:

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

Inclusion Criteria:

  • Low risk prostate cancer T1-2, PSA<10ng/ml, Gleason score (GS) 3+3=6
  • Intermediate risk prostate cancer T1-T2, PSA 10-20ng/ml,GS ≤7(3+4=7 only)
  • World Health Organisation (WHO) performance status 0-2
  • Prostate volume ≤90cc
  • International Prostate Symptom Score (IPSS) ≤20
  • Peak urinary flow rate (Q-max) >10cc/sec
  • Urinary residual <250mls total
  • No prior Trans Urethral Resection of the Prostate (TURP)
  • No previous pelvic radiotherapy
  • Able to give informed consent
  • Aged between 18-85 years of age

Exclusion Criteria:

  • Inflammatory bowel disease
  • Previous androgen deprivation therapy
  • History of urinary retention

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Prospective, Randomized Study Comparing Transperineal and Transrectal Prostate Biopsy Efficacy and Complications (ProBE-PC Trial)


Condition: Prostate Cancer, PSA, Infection

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04081636

Sponsor: Albany Medical College

Eligibility:

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

Inclusion Criteria:

  • All patients who are scheduled to undergo prostate biopsy for suspected prostate cancer as part of their regular medical care
  • Either with or without an MRI

Exclusion Criteria:

  • Patients with no access to rectum (due to previous rectal surgery)
  • Any abnormalities of the perineal skin (e.g. infection)
  • Patients whose procedure requires sedation or general anesthesia

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Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04083937

Sponsor: University Hospital Heidelberg

Eligibility:

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

Inclusion Criteria:

  • histology-proven prostate cancer with Gleason Score and PSA-value;
  • indication for prostate bed irradiation (adjuvant/ salvage) after prostatectomy;
  • Karnofsky-Index ≥ 70%
  • age ≥ 18 years

Exclusion Criteria:

  • androgen deprivation therapy
  • lymphatic spread
  • macroscopic tumor/ R2
  • stage IV (M1)
  • previous irradiation

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CELLO-1: A Phase 1b/2 Open-Label Study Evaluating Tazemetostat in Combination With Enzalutamide or Abiraterone/Prednisone in Chemotherapy Naive Subjects With Metastatic Castration-Resistant Prostate Cancer


Condition: Metastatic Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04179864

Sponsor: Epizyme, Inc.

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Age at the time of consent ≥ 18 years. 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 (Appendix 3. Life expectancy of > 3 months. 4. Histologically or cytologically confirmed adenocarcinoma of the prostate. Small cell or neuroendocrine tumors of the prostate are also permitted. 5. Progressive disease in the setting of medical or surgical castration (ie, castration- resistant prostate cancer [CRPC]) by PCWG3 criteria for study entry.
  • Evidence of disease progression by rising PSA or
  • Soft tissue progression per RECIST 1.1 or
  • Evidence of disease progression by observation of 2 new bone lesions since the initiation of last systemic therapy. 6. Metastatic prostate cancer disease, documented by the following imaging • Bone lesions on bone scan (per PCWG3) or by soft tissue disease (per RECIST 1.1) by CT/MRI imaging Must have undergone bilateral orchiectomy or be willing to continue GnRH analogue or antagonist. 7. Prior treatment with a second-generation androgen inhibitor as follows:
  • For phase 1b, EITHER Previously untreated with or progressed on a second generation androgen inhibitor (abiraterone, enzalutamide, or apalutamide) OR progressed on a second generation inhibitor (inhibitor (abiraterone, enzalutamide, or apalutamide)
  • For phase 2 randomized component (i.e, enzalutamide- containing treatment arms) of the study, previously progressed on abiraterone.

Exclusion Criteria:

  • 1. Known symptomatic brain metastases 2. Treatment with any of the following for prostate cancer within the indicated timeframe prior to day 1 of starting study treatment:
  • First generation: AR antagonists (eg, bicalutamide, nilutamide, flutamide) within 4 weeks.
  • 5-alpha-reductase inhibitors, ketoconazole, estrogens (including diethylstilbesterol), or progesterones within 2 weeks.
  • Chemotherapy (except as permitted in inclusion criteria #10) within 3 weeks.
  • Prior radionuclide therapy within 4 weeks.
  • Another interventional product or standard agent in a clinical study within 28 days prior to the first planned dose of Tazemetostat
  • For phase 2 subjects to be randomized to one of the enzalutamide treatment arms only, prior treatment with the second-generation androgen antagonist including enzalutamide, apalutamide, darolutamide, and proxalutamide, etc. 3. Severe concurrent disease, infection, or comorbidity that, in the judgment of the Investigator, would make the subject inappropriate for enrollment 4. Has had prior exposure to tazemetostat or other inhibitor(s) of enhancer of zeste homologue-2.

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Phase II, Open-label, Single-center Study Evaluating Safety and Activity of Androgen Deprivation Therapy Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer (mHSPC)


Condition: Prostate Cancer Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03951831

Sponsor: Mark Stein

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Be willing and able to provide written informed consent for the trial. 2. Age ≥18 years of age on day of signing informed consent. 3. Have life expectancy > 12 months. 4. Have a performance status of 0 or 1 using the Eastern Cooperative Oncology Group (ECOG) Performance Scale. 5. Have histologically or cytologically confirmed prostate cancer from prostate biopsy, radical prostatectomy, TURP or from biopsy of a metastatic site. Rarely pathology is not available but if clinical situation confirms prostate cancer (such as prior response to androgen ablation and/or metastatic disease typical of prostate cancer, i.e. involving bone or pelvic/extra pelvic lymph nodes or para-aortic lymph nodes, AND an elevated serum concentration of PSA typical of prostate cancer) pathology is not required and patient can be enrolled after discussed with study PI.. 6. Have metastatic disease that is either measurable or evaluable (non-measurable). 7. Have evaluable (non-measurable) or measurable disease, based on RECIST 1.1, with at least one lesion amenable to biopsy. 8. Have testosterone level ≥ 150ng/dL. 9. Have not been on androgen deprivation therapy or novel hormonal agents (e.g., abiraterone, enzalutamide, apalutamide) for at least 6 months prior to enrollment in trial and must not have exceeded 24 months of therapy 10. Have not received any adjuvant or neoadjuvant chemotherapy or immunotherapy. 11. Have not had prior bilateral surgical orchiectomy. 12. Have not received palliative radiation within 14 days of starting ADT on study treatment. 13. Have adequate organ and marrow function as defined below:
  • Leukocytes ≥3,000/microliters (mcL)
  • Absolute Neutrophil Count ≥1,500/mcL
  • Platelets ≥100,000
  • Hemoglobin ≥ 8.0g/dL (without transfusion in past 2 weeks)
  • Prothrombin time (PT)/international normalized ratio (INR), partial thromboplastin time (PTT) ≤ 1.5 upper limit of normal (ULN) (except if on therapeutic anticoagulation in which case the patient can be enrolled if stable and anti-coagulation levels are appropriate for their condition per good clinical practice).
  • Aspartate aminotransferase (AST)(SGOT)/ alanine aminotransferase (ALT)(SGPT) ≤2.5 × institutional ULN
  • Total bilirubin within normal institutional limits. Note: Patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g. Gilbert's syndrome) will be eligible at the discretion of the treating physician and/or the principal investigator.
  • Creatinine clearance of ≥ 30 mL/min. Creatinine clearance (CrCl) should be calculated at screening using the Cockcroft-Gault formula. 14. Agree to undergo serial tumor biopsies, unless medically contraindicated in the opinion of the treating physician, and discussed with the principal investigator 15. The effects of REGN2810 on the developing human fetus are unknown. For this reason and because REGN2810 agents [as well as other therapeutic agents used in this trial] are known to be teratogenic, men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of REGN2810 administration. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.

Exclusion Criteria:

  1. The subject must be excluded from participating in the trial if the subject:
  2. Received ADT or other hormonal agents within 6 months prior to entering the study or in the metastatic setting with the exception of 5-alpha reductase inhibitors (e.g. finasteride and dutasteride) and first-generation androgen receptor inhibitor (e.g. bicalutamide) in setting of normal testosterone. Advise subject to continue the 5-alpha reductase inhibitor for the duration of the study if already started. Advise subject to stop the androgen receptor inhibitor for duration of the study
  3. Received prior immunotherapy (including inhibitors of programmed cell death protein 1 (anti-PD-1), anti-PD-L1, anti-CTLA4, or Sipuleucel-T).
  4. Received prior chemotherapy for prostate cancer treatment.
  5. Received radiation within 2 weeks prior to entering study.
  6. Is receiving any other investigational agents concurrently.
  7. Had a solid organ or hematologic transplant.
  8. Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  9. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  10. Has a diagnosed malignant disease, other than the tumor type being treated in this study. Note: Patients with a prior or concurrent malignancy of low metastatic potential that does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen may be included (e.g., patients with a history of nonmelanoma skin cancer, carcinoma in situ of the cervix, early stage cancers treated with curative intent, non-muscle invasive bladder cancer, stage I renal cancer)Has a known history of, or any evidence of, interstitial lung disease or active noninfectious pneumonitis.
  11. Peripheral neuropathy must be ≤ grade 1
  12. Has an active infection requiring systemic therapy.
  13. Has a history of current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator, including dialysis.
  14. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  15. Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies). Note: HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with REGN28
  16. In addition, these patients are at increased risk of lethal infections when treated with immunotherapy and marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
  17. Has untreated active Hepatitis B. Note: To qualify for enrollment, antiviral therapy for HBV must be given for at least 3 months, and HBV viral load must be less than 100 IU/mL prior to first dose of study drug. Those on active HBV therapy with viral loads under 100 IU/mL should stay on the same therapy throughout trial treatment. Those subjects who are anti-HBc (+), and negative for HBsAg, and negative for anti-HBs, and have an HBV viral load under 100 IU/mL do not require HBV anti-viral prophylaxis, but need close monitoring.
  18. Has dual infection with HBV/HCV or other hepatitis combinations at study entry.
  19. Has received a live vaccine within 30 days of planned start of study therapy (Cycle 1, Day 1). Note: The killed virus vaccines used for seasonal influenza vaccines for injection are allowed; however intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
  20. Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 must be excluded.

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A Phase I/II Study on the Safety and Efficacy of LAE001 in the Treatment of Metastatic Prostate Cancer


Condition: Prostate Cancer Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03843918

Sponsor: Laekna Limited

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Understands the trial procedures and content, and voluntarily signs the written informed consent form. 2. Male ≥ 18 years old. 3. Prostate adenocarcinoma as confirmed by histology or cytology, excluding neuroendocrine differentiation, signet ring cell carcinoma, and small cell carcinoma. 4. Evidence (such as bone scan or CT/MRI findings) of distant metastatic disease. 5. Phase I: According to the definition by PCWG3, disease progression after androgen deprivation therapy is as follows:
  • Disease progression, as defined by PCWG3, is the satisfaction of any of the following: According to elevations in PSA levels, there should be two consecutive elevations in PSA at least one week apart (if the third detected value is greater than the second detected value, the disease is determined to have progressed; if the third detected value is smaller than the second detected value, a fourth test is required to determine whether the PSA value is greater than the second detected value, and the interval between each test shall be at least one week), and the minimum value shall be equal to or greater than 1.0 ng/mL; PSA levels can be ignored for disease progression as assessed according to RECIST 1.1; progression of bone disease as defined by PCWG3, that is, the discovery of two or more new lesions via bone scan.
  • ECOG score of 0-1.
  • Dose-escalation phase: Patients with metastatic castration-resistant prostate cancer who have not received chemotherapy or who have received chemotherapy (chemotherapy failure or intolerance), with preferential enrollment of patients who had failed chemotherapy. Phase II: Patients with metastatic castration-sensitive prostate cancer
  • Meet at least two of the following three high-risk prognostic factors: Gleason score of ≥ 8; presence of three or more lesions on bone scan; presence of measurable visceral metastasis (except lymph node metastasis) indicated by CT or MRI results (RECIST 1.1).
  • ECOG score of 0-2.
  • No disease progression as defined by PCWG3.
  • The patient is not suitable to take or chooses not to take abiraterone. 6. The subject underwent orchiectomy, or LHRH agonist or antagonist therapy before enrollment, and the therapy will be maintained throughout the entire study. The patient was at castration level during screening, i.e., his testosterone level was < 50 ng/dL or 1.7 nmol/L. 7. Adequate hematopoietic function:
  • White blood cell count, WBC ≥ 3,000/μL
  • Absolute neutrophil count, ANC ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Hemoglobin ≥ 9 g/dL 8. Total serum bilirubin ≤ 1.5*ULN (total bilirubin ≤ 3*ULN, and direct bilirubin ≤ 1.5*ULN for patients known to have Gilbert syndrome). 9. AST (aspartate transaminase) and ALT (alanine transaminase) ≤ 2.5*ULN, and AST and ALT ≤ 5*ULN for patients with liver metastasis. 10. Serum creatinine ≤ 1.5*ULN. 11. Fasting plasma glucose ≤ 120 mg/dL or ≤ 6.7 mmol/L. 12. Normal levels of potassium, calcium and magnesium.

Exclusion Criteria:

  1. Patients who had been treated with abiraterone acetate or enzalutamide.
  2. Phase I: Patients who received anti-tumor therapy such as chemotherapy, radiotherapy, targeted therapy, and endocrine therapy with androgen receptor inhibitors within four weeks prior to the first dose (the time from the last treatment with nitrosourea or mitomycin chemotherapeutic agents is < 6 weeks, and the time from the last dose of bicalutamide or nilutamide is < 6 weeks).
  3. Phase II: Patients who received any chemotherapy, radiotherapy or surgery for metastatic prostate cancer before randomization. Exceptions: ADT therapy (LHRH agonist or orchiectomy) before Day 1 of Cycle
  4. Subjects may receive a course of palliative radiotherapy or surgery to treat symptoms caused by metastatic disease (e.g. spinal cord compression or obstruction), provided that it is administered at least 28 days prior to Day 1 of Cycle
  5. All adverse events associated with such treatment must be alleviated to Grade 1 by Day 1 of Cycle
  6. Patients who underwent major surgery (major surgery refers to Grade 3 and Grade 4 surgery as defined in the "Administrative Measures for Clinical Application of Medical Technologies" promulgated on May 01, 2009) within 28 days before the study treatment, or who have not fully recovered from surgery (the investigator determines that the patient's participation in the clinical trial would pose a risk).
  7. Patients with known severe cardiovascular diseases, including: myocardial infarction or thrombotic events in the past six months; unstable angina; heart failure of Class III or IV according to the criteria of the New York Heart Association (NYHA); QTc interval (QTcF) > 450 ms during the screening visit; G3 hypertension that cannot be controlled even with standard treatment, systolic blood pressure >160 mmHg or diastolic blood pressure>100 mmHg).
  8. Patient who have not yet recovered from the toxicity of the former treatment regimen before drug administration on Day 1 of Cycle 1, and still have toxic reactions (excluding hair loss) above Grade 1 according to the grading scale of version 5.0 of the Common Terminology Criteria for Adverse Events (CTCAE).
  9. Patients with clinically obvious gastrointestinal abnormalities that may affect the intake, transportation or absorption of drugs (such as patients who are unable to swallow, have chronic diarrhea or intestinal obstruction, or who had undergone total gastrectomy).
  10. Patients with visceral metastasis involving the adrenal glands and central nervous system.
  11. Patients with evidence of myelosuppression, and hydronephrosis in both kidneys as well as bladder neck obstruction that affects kidney function
  12. Patients with a history of severe central nervous system diseases, including epilepsy.
  13. Patients who had other malignant tumors (except for basal or squamous cell carcinoma) in addition to prostate cancer in the past five years, which are currently clinically significant and require intervention.
  14. Patients who received 5α-reductase inhibitors (finasteride, dutasteride), estrogen, cyproterone and other drugs for treatment within four weeks before randomization, and whose period of drug discontinuation has not exceeded five half-lives of the corresponding drugs; the drugs must have been discontinued for more than two weeks if the half-life is unknown.
  15. Male patients whose sexual partners are women of childbearing age, where the patient and / or his sexual partner do not agree to use highly effective contraceptive measures (i.e. contraceptives with a low failure rate (less than or equivalent to 1% per year) when used consistently and correctly), and continued use of such measures until four weeks after drug discontinuation.
  16. Patients who require systemic steroids or who had received systemic steroids (more than or equivalent to 10 mg of prednisone per day) 30 days before enrollment; topical, inhaled, ophthalmic or intra-articular medications are acceptable.
  17. Patients who need to take diuretics (non-potassium-sparing).
  18. Patients known to have pituitary or adrenal insufficiency.
  19. Patients with known congenital or acquired immunodeficiency, active tuberculosis, etc.
  20. Patients with active infection(s) that require systemic treatment within 10 days prior to signing the informed consent form.
  21. Chronic hepatitis B carriers with untreated chronic active hepatitis B or with HBV DNA ≥ 1000 copies/mL (or ≥ 200 IU/mL), or patients with active hepatitis C.
  22. The patient is currently receiving the following drugs and cannot discontinue the drugs at least one week before starting the study drug: Spironolactone Substrates of CYP1A2, CYP2E1 or CYP2C19, with a narrow therapeutic index Strong inhibitor or strong inducer of CYP1A2 Strong inhibitor of BSEP Grapefruit juice, and herbs such as St. John's wort, kava, ephedra, ginkgo biloba leaves, dehydroepiandrosterone, yohimbine, saw palmetto, and ginseng.
  23. The patient is currently receiving a moderate or strong inhibitor or isoenzyme inducer of CYP3A. Patients taking strong inducers need to discontinue the drug for at least one week, and patients taking strong inhibitors need to at least discontinue the drug before receiving the study treatment.
  24. Patients with other physical, psychological or social problems, including drug abuse, or who are deemed by the investigator to be unsuitable for participation in this study.

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A Phase II Study of Carboplatin, Cabazitaxel and Abiraterone in High Volume Metastatic Castration Sensitive Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03934840

Sponsor: Masonic Cancer Center, University of Minnesota

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Willing and able to provide, or have a legally authorized representative provide, written informed consent and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.
  • Histologically confirmed prostate cancer.
  • High volume metastatic disease (defined as the presence of visceral metastases or ≥3 bone lesions).
  • ADT for ≤3 months by day 1 of study chemotherapy; Prior episodes of ADT are allowed (i.e. ADT used previously in courses of radiation).
  • Testosterone <50 ng/dL. Patients must continue primary ADT with an LHRH analogue if they have not undergone orchiectomy.
  • ECOG Performance Status 0 or 1 (see Appendix A)
  • Patient has adequate bone marrow and organ function as defined by the following laboratory values:
  • Absolute neutrophil count ≥ 1.5 × 10^9/L
  • Platelets ≥ 100 × 10^9/L
  • Hemoglobin ≥ 9 g/dl
  • Serum creatinine ≤ 1.5mg/dL or estimated creatinine clearance ≥ 50 ml/min
  • In the absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x ULN. If the patient has liver metastases, ALT and AST <5 x ULN
  • Total bilirubin < ULN; or total bilirubin ≤3.0 x ULN or direct bilirubin ≤1.5 x ULN in patients with well-documented Gilbert's Syndrome.
  • Sexually active males must use a condom during intercourse while taking study drugs and for 30 days after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. Fertile males must use a condom with spermicide (double barrier method).
  • Age ≥ 18 years

Exclusion Criteria:

  • Prior exposure to any chemotherapy, PARPi, or immunotherapy for prostate cancer.
  • Prior abiraterone or enzalutamide, unless therapy was for < 2 weeks
  • Radiation therapy (including palliative radiotherapy to a metastatic lesion) within 14 days or major surgery (e.g., open abdominal, pelvic, thoracic, orthopedic or neurosurgery) within 28 days of the date of the first dose.
  • Other systemic therapies for prostate cancer within 28 days or 5 half-lives, whichever is shorter, prior to day 1 of chemotherapy (with the exception of anti-androgens like bicalutamide).
  • PSA <2.0 ng/mL at diagnosis.
  • If present, peripheral neuropathy must be ≤ Grade 1
  • Patients with an active second malignancy that could, in the investigator's opinion, potentially interfere with the patient's ability to participate and/or complete this trial.
  • Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria:
  • At least 4 weeks from prior therapy completion (including radiation and/or surgery) prior to starting the study treatment
  • Clinically stable CNS tumor at the time of screening.
  • Baseline screening for CNS metastases is not required unless presence of signs and/or symptoms of involvement
  • Patients with severe psychiatric illness/social situations that would limit compliance with study requirements in the judgment of treating investigator.
  • Patient has a history of non-compliance to medical regimen or inability to grant consent.

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A Study Comparing Intermittent Androgen Depriving Therapy With Or Without Salvage High-Dose Intensity Modulation Radiotherapy (IG-IMRT)To Oligometastatic Pelvic Lymph Nodes In Biochemically-relapsing Prostate Cancer Patients.


Condition: Prostate Cancer, Oligometastasis

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03630666

Sponsor: Institut Cancerologie de l'Ouest

Eligibility:

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

Inclusion Criteria:

  • Histologically-proven prostate adenocarcinoma
  • Age ≥ 18 years
  • Performance Status 0-1
  • Prior radical prostate treatment (surgery and/or radiotherapy)
  • ≤ 5 metastatic pelvic lymph nodes detected by FCH-PET or PSMA-PET
  • Upper limit of metastatic lymph nodes: aortic bifurcation
  • If ADT has been previously administered to the patient, at least 12 months must have elapsed between the predicted duration of the last injection and inclusion of the patient in the study. For this category of patients, serum testosterone must be higher than 6 nmol/L (50 ng/L) prior to inclusion
  • Biochemical relapse (according to the European Association of Urology guidelines) is defined by : Following radical prostatectomy (RP), biochemical recurrence (BCR) is defined by two consecutive rising PSA values > 0.20 ng/ml After primary radiation therapy (RT), the Radiation Therapy Oncology Group (RTOG) and American Society for Radiation Oncology Phoenix Consensus Conference definition of PSA failure is any PSA increase > 2.00 ng/ml higher than the PSA nadir value, regardless of the serum concentration of the nadir.
  • Having given written informed consent prior to any procedure related to the study.
  • Patient is willing and able to comply with the protocol for the duration of the study including all scheduled treatment, visits and examinations.
  • Patient has valid health insurance
  • Subjects who have partners of childbearing potential must be willing to use a method of effective birth control during treatment and for 12 months following completion of treatment with ADT or IG-IMRT.

Exclusion Criteria:

  • Bone or visceral metastases
  • Para-aortic lymph node metastases (above the aortic bifurcation)
  • Presence of more than five metastatic lymph nodes
  • Evidence of local intra-prostatic relapse
  • Evidence of prostate bed relapse in a previously irradiated region. Prostate bed relapses which have not been previously irradiated will not be excluded
  • Evidence of metastasis at initial diagnosis
  • Evidence of distant metastases beyond the pelvic lymph nodes
  • Previous irradiation of pelvic lymph nodes
  • Castration-resistant prostate cancer (CRPC) as defined by : a castrate serum testosterone < 6 nmol/L (50 ng/L)
  • Contraindications to pelvic irradiation (e.g. chronic inflammatory bowel disease)
  • Contraindications to ADT (known hypersensitivity to any of the study drugs or excipients)
  • Severe uncontrolled hypertension defined as systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy
  • Other malignancy treated within the last 5 years (except non-melanoma skin cancer)
  • Patients with a biochemical relapse while on active treatment with LHRH-agonist, LHRH-antagonist, anti-androgen, maximal androgen blockade, or oestrogen
  • Treatment during the past month with products known to influence PSA levels (such as finasteride)
  • In case of previous prostate/prostate bed radiotherapy, PET-positive lymph nodes have to be located outside the previous irradiation field with a maximum of 20 Gy to the PET-positive lymph nodes region
  • Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within a period of 30 days
  • Disorder precluding understanding of trial information or informed consent

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A Feasibility Study of Hypoxia Imaging in Patients With Prostate Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01567800

Sponsor: University Health Network, Toronto

Eligibility:

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

Inclusion Criteria:

  • Age => 18 years
  • Histologic diagnosis of adenocarcinoma of the prostate
  • Bulky intermediate risk, high risk or metastatic prostate cancer Bulky intermediate risk: cT1-2 with >50% of diagnostic biopsy cores containing cancer and Gleason 6 or 7 and prostate specific antigen (PSA) >10 and ≤20 OR High risk: cT1-2 with Gleason score ≥8; or cT1-2 with PSA >20; or cT3 OR N+ and/or M1 disease OR Newly diagnosed hormone-refractory prostate cancer
  • Intention to treat using radiotherapy +/- concurrent and adjuvant hormonal therapy
  • Intention to treat with radiotherapy, hormonal therapy, other systemic treatment for prostate cancer, or a combination of these according to the Princess Margaret Genitourinary Site policies.
  • Previous or concurrent anti-cancer therapy for the PET FAZA target lesion allowed
  • Ability to provide written informed consent to participate in the study

Exclusion Criteria:

  • Inability to lie supine for more than 60 minutes
  • Patients taking the drug disulfiram (Antabuse)
  • Contraindications for MRI: only applicable in cases where the PET FAZA target lesion is identified as the prostate gland. Patients with target lesions at other anatomic sites will not undergo MR imaging.
  • Patients weighing > 136 kg

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Immune Activation and Cellular Response From Enzalutamide Alone or With Radium223 in Men With Metastatic, Castration-Resistant Prostate Cancer


Condition: Castration-Resistant Prostate Carcinoma, Prostate Carcinoma Metastatic in the Bone, Stage IV Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03344211

Sponsor: University of Southern California

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Men with metastatic, castration resistant prostate cancer involving the bone, which is symptomatic or asymptomatic
  • Castration resistance will be defined as the development of disease progression, defined as one of the following:
  • Rising PSA x 2 values >= 2 weeks apart; minimum absolute PSA value 2 ng/mL
  • Radiographic progression, with at least 1 new site of metastasis
  • Symptomatic progression (ex: increase in pain despite stable imaging) AND despite ongoing luteinizing hormone-releasing hormone (LHRH) therapy OR testosterone level < 50
  • Men must have osseous metastases, but the presence of visceral metastases will not exclude patients from participation
  • Prior external beam radiation therapy (> 4 weeks prior to enrollment) for palliation of osseous metastatic disease is allowed, provided there is at least one osseous metastasis which has not been irradiated and which can be biopsied
  • No prior docetaxel or cabazitaxel chemotherapy for metastatic castration-resistant prostate cancer (mCRPC) (men treated with prior docetaxel administered as up-front therapy with androgen deprivation therapy [ADT] > 6 months ago will be eligible); prior abiraterone is allowed
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Hemoglobin >= 9.5 g/dL
  • Absolute neutrophil count >= 1,500
  • Platelets >= 100,000
  • Total bilirubin within normal institutional limits
  • Creatinine clearance (calculated or measured) > 30 mL/min
  • At least one risk factor predicting higher likelihood of bone marrow sample yield: elevated alkaline phosphatase, low hemoglobin, or elevated lactate dehydrogenase (LDH)
  • Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  • Prior treatment with docetaxel or cabazitaxel for mCRPC
  • Prior treatment with ARN-509 or enzalutamide (there is a grace period for men who wish to enroll and who have recently started enzalutamide for the first time but have taken less than 15 days of therapy)
  • Concurrent use of androgen deprivation therapy aside from LHRH agonist or antagonist (i.e. bicalutamide, flutamide, nilutamide, abiraterone, ketoconazole, estrogen); there will be a 2 week wash-out period from the last dose of any of these agents until the first dose of enzalutamide on study; patients who have just started enzalutamide for fewer than 5 doses prior to enrollment in the trial are still considered eligible and not subject to wash-out
  • Concurrent oral corticosteroid use aside from adrenal replacement, or use of other immunosuppressive agents (ex: infliximab); topical or inhaled steroids will be allowed
  • Received systemic therapy with radionuclides (e.g., strontium-89, samarium- 153, rhenium-186, or rhenium-188, or radium Ra 223 dichloride) for the treatment of bony metastases
  • History of seizures except for remote with specific etiology which has resolved (ex: alcohol induced seizure); transient ischemic attack (TIA) or cerebrovascular accident (CVA) within last 6 months
  • Known untreated central nervous system (CNS) metastases; leptomeningeal disease will be an absolute exclusion criterion due to limited life expectancy
  • Chronic diarrhea > grade 1, or a diagnosis of Crohn?s or ulcerative colitis
  • Known hepatitis (hep) B or C, or known cirrhosis (screening for viral hepatitis is not required)
  • Uncontrolled intercurrent illness such as infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness which would limit compliance with study requirements
  • Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI); treatment should be completed for spinal cord compression

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PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer


Condition: Prostate Cancer, Prostate Neoplasm

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03232164

Sponsor: University of Wisconsin, Madison

Phase: Early Phase 1

Eligibility:

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

Inclusion Criteria:

  • Prostate cancer pathologically proven by prostate biopsy
  • Two consecutive rising PSA value
  • Total testosterone < 50 ng/dL
  • imaging evidence of suspected metastatic disease, including CT, bone scan, MRI, ultrasound or other PET modalities

Exclusion Criteria:

  • Radiation therapy or start of standard of care systemic therapy (chemotherapy, androgen deprivation therapy) within 14 days prior to study PET
  • Investigational therapy for prostate cancer less than 28 days prior to study PET imaging.
  • Unable to lie flat during or tolerate PET/CT
  • Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
  • Serum creatinine > 3 times the upper limit of normal
  • Total bilirubin > 3 times the upper limit of normal
  • Liver Transaminases > 5times the upper limit of normal

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Phase II Trial of Combination Immunotherapy in Biochemically Recurrent Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03315871

Sponsor: National Cancer Institute (NCI)

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Histopathological documentation of prostate cancer confirmed in either the Laboratory of Pathology at the National Institutes of Health (NIH) Clinical Center, or Walter Reed National Military Medical Center prior to enrollment. If no pathologic specimen is available, participants may enroll with a pathologist s report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease.
  • Recovery to baseline from acute toxicity related to prior therapy, including surgery and radiation. (28 days removed from last systemic therapy, 14 days removed from last radiation therapy).
  • Hepatic function eligibility parameters (within 16 days before starting therapy): --Bilirubin less than or equal to ULN (OR in participants with Gilbert s syndrome, a total bilirubin less than or equal to 3.0), AST and ALT less than or equal to 1.5 times upper limit of normal.
  • Adequate renal function defined by an estimated creatinine clearance > 50 mL/min according to the Cockcroft-Gault formula or by measure of creatinine clearance from 24 hour urine collection.
  • No other active malignancies within the past 36 months (with the exception of nonmelanoma skin cancers or carcinoma in situ of the bladder) or life-threatening illnesses.
  • Willing to travel to the NIH for follow-up visits.
  • 18 years of age or older.
  • Able to understand and sign informed consent.
  • The effects Prostvac and CV301 on the developing human fetus are unknown. For this reason, men must agree to use highly effective contraception (that is, methods with a failure rate of less than 1% per year) prior to study entry, for the duration of study therapy and at least four months after the last treatment administration. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.
  • Additional Inclusion Criteria Specific to Safety Lead-In Cohort
  • Castrate testosterone level (<50ng/dl or 1.7nmol /L)
  • Progressive disease at study entry defined as one or more of the following criteria occurring in the setting of castrate levels of testosterone:
  • Radiographic progression defined as any new or enlarging bone lesions or growing lymph node disease, consistent with prostate cancer OR
  • PSA progression defined by sequence of rising values separated by >1 week (2 separate increasing values over a minimum of 2ng/ml (PCWG2 PSA

Eligibility Criteria:

  • ). If participants had been on flutamide, PSA progression is documented 4 weeks or more after withdrawal. For participants on bicalutamide or nilutamide disease progression is documented 6 or more weeks after withdrawal. --Participants must agree to continuation of androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone agonist/antagonist or bilateral orchiectomy
  • ECOG performance status of 0-2 (Karnofsky >80%).
  • Hematological eligibility parameters (within 16 days before starting therapy):
  • Granulocyte count greater than or equal to 1000/mm^3
  • Platelet count greater than or equal to 100 000/mm^3
  • Hgb greater than or equal to 9 g/dL
  • PT less than or equal to 1.5 x ULN
  • aPTT less than or equal to 1.5 x ULN Additional Inclusion Criteria Specific to Biochemical Recurrence Cohort
  • Biochemical progression defined as follows:
  • For participants following definitive radiation therapy: a rise in PSA of greater than or equal to 2 ng/mL above the nadir (per RTOG-ASTRO consensus criteria)
  • For participants following radical prostatectomy: rising PSA after surgical procedure (participants must have a PSA greater than or equal to 0.8 ng/mL)
  • Participants must have a rising PSA as confirmed by 3 values a minimum of 1 week apart over at least a 1 month period of time.
  • Participants must have a PSA doubling time of 5-15 months.
  • ECOG performance status of 0-1 (Karnofsky greater than or equal to 80%).
  • Negative CT scan/MRI and bone scan for metastatic prostate cancer.
  • Baseline testosterone greater than or equal to 100 ng/dl.
  • PSA less than or equal to 30 ng/mL.
  • Hematological eligibility parameters (within 16 days before starting therapy):
  • Granulocyte count greater than or equal to 1000/mm3
  • Platelet count greater than or equal to 100 000/mm3
  • Hgb greater than or equal to 10 g/dL

Exclusion Criteria:

  • Immunocompromised status due to:
  • Human immunodeficiency virus (HIV) positivity.
  • Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease.
  • Participants with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including CNS, heart, lungs, kidneys, skin, and GI tract will be allowed.
  • Participants with diabetes type I, vitiligo, or alopecia are allowed.
  • Other immunodeficiency diseases
  • Splenectomy
  • Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g. corneal transplant, hair transplant).
  • Chronic administration (defined as daily or every other day for continued use > 14 days) of systemic corticosteroids within 28 days before the first planned dose of investigational therapy. Use of corticosteroids with minimal systemic absorption (e.g. inhaled steroids, nasal sprays, and topical agents) is allowed.
  • Serious intercurrent medical illness that, in the judgment of the investigator, would interfere with participant s ability to carry out the treatment program.
  • Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g. phytoestrogens and saw palmetto).
  • History of prior chemotherapy (chemotherapy allowed for lead-in cohort in castration resistant disease.)
  • History of prior immunotherapy within the last 3 years (immunotherapy allowed for lead-in cohort in castration resistant disease.)
  • Receipt of an investigational agent within 28 days (or 56 days for an antibody-based therapy) before the first planned dose of study drugs.
  • Major surgery within 4 weeks prior to enrollment
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to poxviral vaccines (e.g., vaccinia vaccine)
  • Previous serious adverse reactions to smallpox vaccination
  • History of allergic reactions attributed to monoclonal antibodies (grade 3)
  • Known allergy to eggs, egg products, aminoglycoside antibiotics (e.g. gentamicin or tobramycin).
  • History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis
  • Unable to avoid close contact or household contact with the following high-risk individuals for three weeks after the Day 1 vaccination: (a) children less than or equal to 3 years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders, or (d) immunocompromised individuals, such as those with HIV.
  • Participants who test positive for HBV or HCV
  • Clinically significant cardiovascular/cerebrovascular disease as follows: cerebral vascular accident/stroke (< 6 months prior to the first planned dose of study drugs), myocardial infarction (< 6 months prior to the first planned dose of study drugs), unstable angina, congestive heart failure (New York Heart Association Classification Class greater than or equal to II), serious cardiac arrhythmia, or uncontrolled hypertension (SBP>170/DBP>105).
  • Participants who have received a red cell transfusion within 2 weeks prior to enrollment.
  • Participants unwilling to accept blood products as medically indicated.
  • Individual tumor lesion(s) in the liver or chest which are 10 cm or larger.

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Prostate Advanced Radiation Technologies Investigating Quality of Life (PARTIQoL): A Phase III Randomized Clinical Trial of Proton Therapy vs IMRT for Low or Intermediate Risk Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01617161

Sponsor: Massachusetts General Hospital

Eligibility:

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

Inclusion Criteria:

  • Diagnosed with histologically confirmed adenocarcinoma of the prostate based on core-biopsy within 1 year of study entry from TRUS
  • Clinical stages T1c to T2c
  • PSA <20, within 6 months of study entry
  • Participants who are currently receiving Dutasteride (or have received it within the last 90 days) or Finasteride (or have received it within the last 30 days) must have a PSA of ≤ 10
  • Gleason score ≤6, 3 + 4 = 7, or 4 + 3 = 7
  • ECOG Performance Status 0-1 as documented within 3 months prior to study entry
  • Must have complete history and physical examination within 45 days of study entry and digital rectal examination of prostate within 180 days of study entry

Exclusion Criteria:

  • Prior surgery (not including TURP), cryosurgery, radiofrequency ablation, chemotherapy or radiation for PCa
  • Prior or planned androgen deprivation or bilateral orchiectomy
  • Distant metastases, or clinically or pathologically involved lymph nodes confirmed by a CT scan within 365 days of study entry
  • Hip prosthesis, inflammatory bowel disease or connective tissue disorder such as active scleroderma or lupus
  • Individuals with a history of other malignancies are ineligible unless 1) they have been disease-free for at least 5 years OR 2) are deemed by the investigator to be at low risk for recurrence of that malignancy with no plans for adjuvant systemic chemotherapy and/or radiation therapy and have received overall principal investigator approval.
  • Individuals who have AIDS (CD4 < 200 or an AIDS-defining illness) or are HIV positive and not on HAART therapy are ineligible.
  • Major medical or psychiatric illness
  • Individuals with any of the following conditions are excluded from this study:
  • 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
  • History of Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects within the last 12 months

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The BARCODE 2 Study - The Use of Genetic Profiling to Guide Prostate Cancer Treatment


Condition: Hormone Refractory Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02955082

Sponsor: Institute of Cancer Research, United Kingdom

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  1. All study participants will be assessed according to the part 1 and/ or part 2 inclusion criteria depending on which part of the study they enter initially. For Part 1 (genetic screening) of the study:
  2. Age ≥ 18 years.
  3. Recorded diagnosis of prostate cancer with or without histological confirmation. Patients who have not previously undergone a prostate (or metastatic) biopsy but are confirmed to have a raised PSA (>80ng/ml at any time), metastatic disease on imaging and have undergone treatment for mCRPC are eligible.
  4. Castration-resistant disease defined as biochemical or radiological progression on/after treatment with orchidectomy or LHRH analogues as per PCWG3 criteria.
  5. Confirmed metastatic disease on conventional imaging methods such as CT, bone scan or PET imaging.
  6. Current or previous treatment includes at least one of the following:
  7. Docetaxel (either in hormone sensitive or resistant setting; Patients who have completed treatment with or are currently undergoing Cabazitaxel chemotherapy are also eligible)
  8. Enzalutamide
  9. Abiraterone
  10. Adequate renal function measured by calculated GFR (Cockcroft-Gault) >30ml/min. If a participant had renal dysfunction that is expected to improve, they may be considered for part 1 of the study.
  11. Adequate haematological function to allow study entry in line with local hospital practice or at the investigator's discretion.
  12. WHO performance status 0-2 as assessed and documented by study doctor.
  13. Life expectancy >12 weeks
  14. Participants with stable, treated brain metastases will be eligible providing informed consent can be given and that other sites of measurable disease are present
  15. The subject is capable of understanding and complying with the protocol requirements and has signed the BARCODE 2 informed consent form. In addition to the above, for Part 2 of the study:
  16. Confirmed pathogenic germline mutation in a DNA repair gene. (Participants with a known germline mutation will need to provide a report from the external laboratory where genetic testing was carried out)
  17. Previous treatment with docetaxel and abiraterone or enzalutamide with documented disease progression prior to entry to part 2 (rising PSA and/or radiographic progression). Patients previously treated with cabazitaxel and who have documented disease progression are also eligible.
  18. Adequate haematological function: Haemoglobin (Hb) ≥8.0g/dL, neutrophil count ≥1.5x109/L and platelets ≥100x109/L.
  19. Adequate liver function: Total bilirubin ≤1.5 x upper limit of normal (ULN) except for participants with known Gilbert's syndrome; AST and ALT ≤ 2.5x ULN in the presence of liver metastases.
  20. Adequate renal function: creatinine clearance >30ml/min measured by a glomerular filtration rate (GFR) clearance test. If a measured GFR test is not available, then calculated GFR is acceptable (measured GFR must be carried out by cycle 2 of carboplatin).

Exclusion Criteria:

  1. (for part 1 and 2):
  2. Critical organ metastases (e.g. spinal metastases with risk of cord compression) as documented on most recent imaging report.
  3. Participants with bleeding tumours.
  4. Previous treatment with a platinum chemotherapy drug for prostate cancer.
  5. Previous treatment with a PARP inhibitor
  6. Participants with a history of severe allergic reaction to carboplatin or other platinum-containing compounds
  7. Exposure to yellow fever vaccine in the previous 6 months.
  8. Participants unfit for chemotherapy or those with ongoing neuropathy >grade 1 (sensory or motor) according to NCI CTCAE V4.
  9. Known and documented hearing impairment
  10. Other active malignancies or previous malignancies likely, in the PI's opinion, to impact on management of mCRPC.
  11. Significant documented cardiovascular disease: severe/unstable angina, myocardial infarction less than 6 months prior to trial entry, arterial thrombotic events less than 6 months prior to trial entry, clinically significant cardiac failure requiring treatment (NYHA II-IV).
  12. Cerebrovascular disease (CVA or TIA) in the preceding 2 years to entry to Part 2 of study.
  13. Presence of symptomatic brain metastases.

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18F-Fluciclovine PET CT as an Indicator of Therapeutic Response in Metastatic Prostate Carcinoma (M1PCa)


Condition: Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04134208

Sponsor: M.D. Anderson Cancer Center

Phase: Phase 4

Eligibility:

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

Inclusion Criteria:

  • Histologically or cytologically proven prostate carcinoma
  • Documented evidence of M1 disease by American Joint Committee on Cancer (AJCC) staging by bone scan, CT and magnetic resonance imaging (MRI)
  • Castration naive disease, no prior systemic therapy for prostate cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Ability to understand and willingness to sign informed consent

Exclusion Criteria:

  • Known brain metastasis
  • Small cell carcinoma of the prostate

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A Randomized Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) With or Without Durvalumab (MEDI4736) in Oligometastatic Recurrent Hormone Sensitive Prostate Cancer Patients


Condition: Node; Prostate, Bone Metastases, Prostate Cancer Patients

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03795207

Sponsor: Institut Cancerologie de l'Ouest

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations 2. Age > or = 18 years at time of study entry 3. Histologically proven diagnosis of prostate cancer (PCa) 4. PCa patients with a biochemical recurrence "Rising PSA" following treatment with curative intent (radical prostatectomy, primary radiotherapy or a combination of both) as defined by the EAU guidelines. 5. A maximum of 5 bone or lymph node metastases, seen only on FCH-PET CT or Ga-PSMA PET CT, not seen on conventional imaging assessments (bone scan or thorax, abdomen and pelvis CT scan). 6. WHO performance state 0-1 7. Controlled primary tumor. In case the PSA > 0,2 ng/ml in the postoperative setting patients are eligible if a multiparametic MRI or PET scan of the prostate bed rules out a local relapse. Patients after primary radiotherapy should undergo MRI of the prostate according to the European Society of Urogenital Radiology (ESUR) guidelines to rule out local relapse. In case of a suspicious lesion, a biopsy should confirm local recurrence and patients should be referred for local salvage prostatectomy when distant metastases are ruled out. If MRI rules out local relapse, patients are eligible. 8. If ADT has been previously administered to the patient, a minimum of 12 months must have elapsed between the predicted duration of the last injection and inclusion of the patient in the study. For this category of patients, serum testosterone has to be higher than 8.5 nmol/l prior to inclusion. 9. Adequate normal organ and marrow function as defined below:
  • Haemoglobin ≥9.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1.5 x 103 /L (≥ 1500 per mm3)
  • Platelet count ≥ 75 x 109/L (≥75,000 per mm3)
  • Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysishaemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
  • AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN
  • Measured creatinine clearance (CL) ≥ 40 ml/min or Calculated creatinine CL ≥ 40 ml/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance: Creatinine CL (ml/min) = Weight (kg) x (140
  • Age) 72 x serum creatinine (mg/dL) 10. Body weight > 30kg 11. Life expectancy of > 24 months. 12. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. 13. Social insurance

Exclusion Criteria:

  • 1. Serum testosterone level < 8.5 nmol/ml 2. Vertebral metastases with a minimum distance inferior to 5 mm between GTV (gross tumor volume) and spinal cord 3. Visceral metastases 4. Bone metastases seen on bone scan 5. Lymph nodes greater than 20 mm 6. PSA doubling time less than 6 months 7. Spinal cord compression 8. Any unresolved toxicity NCI CTCAE (v4.03) Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
  • Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
  • Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician. 9. PSA rise while on active treatment (LHRH-agonist, LHRH-antagonist, anti-androgen, maximal androgen blockade, oestrogen) 10. Lung, Brain, Liver or other visceral metastases 11. Relapsed primary tumor 12. Perihilar lymphnode metastases 13. Previous irradiation of the oligometastatic site using a dose > 20 Gy less than 5 years ago. 14. Previous treatment with a cytotoxic agent for PCa 15. Treatment during the past month with products known to influence PSA levels (e.g. fluconazole, finasteride, corticosteroids...) 16. Particimmunotherapyation in another clinical study with an investigational product during the last 4 weeks 17. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study 18. Any prior immune therapy (CTLA-4, PD1 (Programmed cell death )1 or PD-L1 inhibitor, including durvalumab) 19. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
  • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) 20. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug 21. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of Durvalumab. 22. History of allogenic organ transplantation. 23. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
  • Patients with vitiligo or alopecia
  • Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
  • Any chronic skin condition that does not require systemic therapy
  • Patients without active disease in the last 5 years may be included but only after consultation with the study physician
  • Patients with celiac disease controlled by diet alone 24. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement 25. History of another primary malignancy except for
  • Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of immunotherapy and of low potential risk for recurrence
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated carcinoma in situ without evidence of disease 26. History of leptomeningeal carcinomatosis 27. History of active primary immunodeficiency 28. Active infection including tuberculosis, hepatitis B (known positive HBV (hepatitis B virus) surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV (hepatitis B virus) infection (defined as the presence of hepatitis B core antibody [anti-HBc (hepatitis B core antigen)] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. 29. Receipt of live attenuated vaccine within 30 days prior to the first dose of immunotherapy. Note: Patients, if enrolled, should not receive live vaccine whilst receiving immunotherapy and up to 30 days after the last dose of immunotherapy. 30. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients. 31. Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment. 32. Male patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period.

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A Randomized Study of Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01794403

Sponsor: University of Miami

Eligibility:

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

Inclusion Criteria:

  • 1. Histologically proven prostate adenocarcinoma.
  • Gleason score 2-7 (reviewed by reference lab at UM).
  • Biopsy within one year of date of enrollment. 2. Clinical stage ≤ T2 based on DRE and/or ≤ T3a based on MRI (if done); N0-Nx; M0-Mx (AJCC 7th Edition)
  • T-stage and N-stage determined by physical exam and available imaging studies (CT, and/or MRI of the pelvis; see section 4.5). For MRI, questionable extracapsular extension is permitted. To distinguish blood from tumor the ideal study would be to acquire T2, T1 noncontrast and T1 dynamic contrast enhanced sequence, although this is not required. A small amount of extracapsular extension is permitted, as long as it can be included in the clinical target volume (CTV) and the constraints are met.
  • M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases. 3. Prostate-Specific Antigen (PSA) < 20 ng/ml, obtained no greater than 3 months prior to enrollment. 4. Patients belonging in one of the following risk groups:
  • Low:
  • Clinical stage* T1-T2; Gleason ≤ 6, PSA ≤ 10 & <50% biopsy cores positive.
  • Intermediate:
  • Clinical stage T2b-T2c; Gleason ≤ 6, PSA ≤ 10 & <50% biopsy cores positive.
  • Clinical stage T1-T2; Gleason ≤ 6, PSA ≤ 10 & ≥50% biopsy cores positive.
  • Clinical stage T1-T2; Gleason = 7, PSA ≤ 10 & <50% biopsy cores positive or T1-T2; Gleason ≤ 6 & PSA >10 and < 20 & < 50% biopsy cores positive.
  • MRI stage T3a with evidence of extraprostatic extension is allowed.
  • Clinical stage is based on digital rectal exam (DRE). Seminal vesicle invasion on MRI is not eligible. T1a should be permitted if subsequent peripheral zone biopsies show tumor. 5. Prostate volume: ≤ 80 cc.
  • Determined using: volume = π/6 x length x height x width.
  • Measured from CT or MRI ≤90 days prior to enrollment. 6. Zubrod performance status 0-1. 7. No prior total prostatectomy or cryotherapy of the prostate.
  • Prior suprapubic prostatectomy, transurethral resection and laser ablation are permitted. 8. No prior radiotherapy to the prostate or lower pelvis. 9. No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion. 10. No chemotherapy for a malignancy in the last 5 years. 11. No history of an invasive malignancy (other than this prostate cancer, or nonmetastatic basal or squamous skin cancers) in the last 5 years. 12. 4-6 months of androgen deprivation therapy (ADT) are allowed for intermediate risk patients. This must be declared prior to randomization. This may not have been started more than 2 months prior to randomization. 13. Patient must be able to have gold fiducial markers placed in the prostate (if on anticoagulants, must be cleared by a primary care physician or cardiologist), or if patient already has fiducial marker placed, they must be in accordance with the protocol specifications (Section 4.2.2). NOTE: If a method of intrafraction prostate tracking is available which does not require fiducial markers, this will be adequate for this trial (i.e. 4D transperitoneal ultrasound, onboard MRI guidance). 14. Ability to understand and the willingness to sign a written informed consent document. 15. Willingness to fill out quality of life/psychosocial forms. 16. Age >= 35 and =< 85 years. 17. IPSS (AUA) score ≤12

Exclusion Criteria:

  1. Does not have a diagnosis of prostate adenocarcinoma.
  2. Patient has clinical T3a or any evidence of T3b disease.
  3. Patient has stage N1 or M1 disease.
  4. Patients has a PSA of greater than 20 ng/ml, obtained no greater than 3 months prior to randomization.
  5. Patient does not meet any of the risk groups outlined in section 3.1.
  6. Prostate volume greater than 80 cc.
  7. Zubrod performance status 2 or greater.
  8. Prior total prostatectomy.
  9. Prior radiation therapy to the prostate or lower pelvis.
  10. Implanted hardware which limits treatment planning or delivery (determined by the investigator).
  11. Chemotherapy within the past 5 years.
  12. Diagnosis of an invasive malignancy within 5 years (other than current prostate cancer or non-metastatic basal or squamous skin cancers or non-metastatic curatively treated papillary thyroid carcinoma).
  13. The use of more than 2 months of androgen deprivation therapy (ADT) prior to randomization, or plans for ADT to be continued for greater than 6 months.
  14. Inability to have gold fiducial markers placed in the prostate, or fiducial markers already placed that are not in accordance with the protocol (Section 4.2.2). NOTE: If a method of intrafraction prostate tracking is available which does not require fiducial markers, this will be adequate for this trial (i.e. 4D transperitoneal ultrasound, onboard MRI guidance).
  15. Unwilling or inability to give informed consent.
  16. Not willing to fill out quality of life/psychosocial questionnaires.
  17. IPSS score > to
  18. Age < 35 and > 85 years.

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