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Prostate Cancer clinical trials at UCSF
74 in progress, 35 open to new patients

  • A Phase 1 Trial for Safety and Imaging Evaluation of CTT1057, a Small Molecule Inhibitor of Prostate Specific Membrane Antigen (PSMA)

    open to eligible males ages 18 years and up

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

    San Francisco, California

  • A Phase II Study of Itraconazole in Biochemical Relapse

    open to eligible males ages 18 years and up

    This study is being done to test an investigational drug called itraconazole in the treatment of prostate cancer.

    San Francisco, California

  • A Pilot Study of (MR) Imaging With Pyruvate (13C) to Detect High Grade Prostate Cancer

    open to eligible males ages 18 years and up

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

    San Francisco, California

  • A Randomized Phase 2 Trial of Combining Sipuleucel-T With Immediate vs. Delayed CTLA-4 Blockade for Prostate Cancer

    open to eligible males ages 18 years and up

    The purpose of this study is to find out what effects taking ipilimumab, as an immediate or delayed treatment, following completion of sipuleucel-T (SipT) treatment, has on patients and their prostate cancer.

    San Francisco, California and other locations

  • A Study of ZEN003694 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer

    open to eligible males ages 18 years and up

    This is an open label, non-randomized, Phase 1b, dose escalation and dose confirmation study of ZEN003694 in combination with enzalutamide in patients with mCRPC.

    San Francisco, California and other locations

  • A Study of ZEN003694 in Patients With Metastatic Castration-Resistant Prostate Cancer

    open to eligible males ages 18 years and up

    This is an open label, Phase 1, dose escalation and dose confirmation study of ZEN003694 in patients with mCRPC.

    San Francisco, California and other locations

  • Active Surveillance Exercise Clinical Trial

    open to eligible males ages 18 years and up

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

    San Francisco, California

  • ADXS31-142 Alone and in Combination With Pembrolizumab (MK-3475) in Patients With Prostate Cancer - KEYNOTE-046

    open to eligible males ages 18 years and up

    A Phase 1/2 multicenter, dose determining, open-label study of ADXS31-142 monotherapy and a combination of ADXS31-142 with Pembrolizumab (MK-3475) in patients with metastatic castration-resistant prostate cancer. Part A will be dose-determining of ADXS31-142 monotherapy. Part B will be dose-determining of ADXS31-142 and Pembrolizumad (MK-3475) in combination. Part B expansion will treat additional patients with the recommended dose from Part B.

    San Francisco, California and other locations

  • Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

    open to eligible males ages 18 years and up

    RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells.

    PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.

    San Francisco, California and other locations

  • Best Systemic Therapy or Best Systemic Therapy (BST) Plus Definitive Treatment (Radiation or Surgery)

    open to eligible males ages 18 years and up

    The goal of this clinical research study is to learn if treatment with standard systemic therapy (androgen deprivation therapy or bilateral orchiectomy) in combination with surgery or radiation therapy is more effective at controlling prostate cancer than standard systemic therapy alone. The safety of this treatment combination will also be studied.

    San Francisco, California and other locations

  • CHAMP: A Randomized Controlled Trial of High-intensity Aerobic and Resistance Exercise for Metastatic Prostate Cancer

    open to eligible males ages 18 years and up

    This Phase II, open-label, three-arm randomized controlled trial (RCT) will investigate the effects of 12 weeks of supervised aerobic exercise vs. 12 weeks of supervised resistance exercise vs. usual care in men with metastatic castration resistant prostate cancer to determine the safety, feasibility, and tolerance of exercise; quality of life indicators, and a prognostic score.

    San Francisco, California

  • Decipher Genomics Resource Information Database

    open to eligible males

    To prospectively evaluate the utility of genomic expression data as a tool to better characterize the tumors of individual patients, and to understand how genomic information from individual patients undergoing routine clinical testing can be used in population-level analysis to improve treatment and outcomes.

    San Francisco, California and other locations

  • Decision Support Tools for Men With Prostate Cancer- Clinical & Lifestyle Model

    open to eligible males ages 18 years and up

    A UCSF PI-initiated study with a primary goal to improve decision quality, anxiety, and uncertainty, thereby increasing appropriate uptake of active surveillance and reducing over-treatment of low-risk prostate cancer. This study involves: completion of questionnaires through the secure website; consultation by a health coach to aid men with prostate cancer in making informed treatment decision (personalized coaching session(s)), bio-specimen collection/analysis.

    San Francisco, California and other locations

  • Evaluation of Gallium-68-HBED-CC-PSMA Imaging in Prostate Cancer Patients

    open to eligible males ages 18 years and up

    The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68 HBED-CC PSMA) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy, patients with biochemical recurrence and patients with castrate resistant prostate cancer.

    San Francisco, California

  • Gallium-68 Citrate PET Used in Prostate Cancer

    open to eligible males ages 18 years and up

    This is a single center cross-sectional imaging study investigating the use of gallium-68 citrate PET in patients with metastatic castration-resistant prostate cancer who are planning to undergo a metastatic tumor biopsy on protocol CC# 125519. The study population will consist of patients with metastatic castration-resistant prostate cancer who are undergoing a metastatic tumor biopsy as part of clinical protocol CC# 125519, with evidence of resistance to androgen signaling inhibition. The study will involve gallium-68 PET scan obtained at single time point, followed by radiographically-guided metastatic tumor biopsy within 14 days of PET scan.

    San Francisco, California

  • Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients

    open to eligible males ages 18 years and up

    The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy.

    San Francisco, California

  • Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

    open to eligible males ages 18 years and up

    The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.

    San Francisco, California

  • Genetic and Molecular Mechanisms in Assessing Response in Patients With Prostate Cancer Receiving Enzalutamide Therapy

    open to eligible males ages 18 years and up

    This clinical trial studies genetic and molecular mechanisms in assessing response in patients with prostate cancer receiving enzalutamide therapy. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as enzalutamide, may lessen the amount of androgens made by the body. Studying samples of tissue and blood in the laboratory from patients with prostate cancer may help doctors better understand hormone resistant prostate cancer. It may also help doctors make improvements in prostate cancer treatment.

    San Francisco, California and other locations

  • LEE011 (Ribociclib) in Combination With Docetaxel Plus Prednisone in mCRPC

    open to eligible males ages 18 years and up

    This is a Phase Ib/II open label clinical trial in patients with metastatic castration resistant prostate cancer. The objective of the phase Ib portion of the study is to establish the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of docetaxel (75 mg/m2 IV q21 days) and prednisone (5mg orally BID) in combination with ribociclib in escalating oral daily doses in patients with metastatic CRPC with prior resistance to abiraterone and/or enzalutamide who have not undergone prior chemotherapy for metastatic disease. Up to three cohorts will be enrolled to determine the MTD and DLT profile of this combination during Phase 1b. Dose escalation will follow the standard 3+3 design. The dosing schedule is being chosen to allow patients to be exposed to the most efficacious dosing schedule of docetaxel (75 mg/m2 every 3 weeks). If there is excess toxicity observed with the treatment combination at the first dose level (dose level I), an alternative dosing schema may be pursued with weekly docetaxel treatment (35 mg/m2 weekly), which has demonstrated activity in mCRPC and decreased risk of cytopenias compared with every 3 week dosing schedule. The Phase II portion (N = 29) of the study is a single arm, two stage, open-label study of ribociclib (dosed at the RP2D) in combination with docetaxel and prednisone to determine the efficacy and further define the safety of the treatment combination. Patients will be treated with the combination of ribociclib plus docetaxel + prednisone for up to 9 cycles. If there is no evidence of radiographic or clinical disease progression after 9 cycles of protocol therapy, patients may continue on single agent maintenance ribociclib until the time of disease progression. Patients will have the option of starting maintenance ribociclib after 6 cycles of docetaxel if stable disease or better on re-staging scans. The dose of ribociclib used during maintenance will be the same dose as that immediately preceding cessation of docetaxel treatment.

    San Francisco, California and other locations

  • Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (HP) (13C) in Castration-Resistant Prostate Cancer

    open to eligible people ages 18 years and up

    This is a prospective imaging study evaluating the utility of baseline metabolic MR imaging with Hyperpolarized Pyruvate (HP) (13C) as a predictive response biomarker to androgen signaling inhibition in patients with castration-resistant prostate cancer.

    San Francisco, California

  • Molecular Features and Pathways in Predicting Drug Resistance in Patients With Metastatic Hormone-Resistant Prostate Cancer Receiving Enzalutamide

    open to eligible males

    This research trial studies molecular features and pathways in predicting drug resistance in patients with hormone-resistant prostate cancer that has spread to other parts of the body and who are receiving enzalutamide. Studying samples of blood and tissue in the laboratory from patients receiving enzalutamide may help doctors learn more about molecular features and pathways that may cause prostate cancer to be resistant to the drug.

    San Francisco, California and other locations

  • MRI With C13 Pilot Study Prostate Cancer

    open to eligible males ages 18 years and up

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

    San Francisco, California

  • Multidisciplinary Study of Androgen Deprivation Therapy (ADT) in Prostate Cancer

    open to eligible males ages 18 years and up

    Randomized, phase 2 study to assess the impact of the multi-disciplinary STAND clinic on changes in key metabolic parameters, quality of life, and patient satisfaction among men receiving androgen deprivation therapy for prostate cancer. Standard-of-care therapy will consist of every 3-month visits comprised of review of medical history, toxicity assessment, and lifestyle modification counseling provided by a dietitian and exercise physiologist on an as-needed basis. Men randomized to participate in the multi-disciplinary STAND clinic will have, in addition to every 3-month visits with an individual health care provider, structured and individualized exercise and dietary counseling. A separate non-randomized patient cohort of 20 patients who are receiving concurrent chemohormonal therapy will be enrolled in parallel. The primary hypothesis of the study is that active participation in a multi-disciplinary clinic, as compared to current standard-of-care, will lead to lessened impact of androgen deprivation therapy on metabolic parameters and improved quality of life.

    San Francisco, California

  • Neoadjuvant PROSTVAC-VF With or Without Ipilimumab for Prostate Cancer

    open to eligible males ages 18 years and up

    This is a multicentered, open label, randomized phase II trial of PROSTVAC or ipilimumab or the combination of PROSTVAC and ipilimumab as neoadjuvant therapy in patients with localized PC. Eligible patients will be randomized to PROSTVAC monotherapy (Arm A), ipilimumab monotherapy (Arm B), or combination therapy with both PROSTVAC and ipilimumab (Arm C), prior to RP. In arms A and C, PROSTVAC-V will be administered subcutaneously as the primary vaccine on Day 1, which will be followed 2 weeks later with a series of 2 PROSTVAC-F subcutaneous administrations, given 3 weeks apart. In arms B and C, ipilimumab will be administered twice, at a dose of 3mg/kg, 3 weeks apart. In the combination arm, ipilimumab administration will coincide with the PROSTVAC-F administration. In arm B, ipilimumab will begin on Day 1. In all three arms, RP will occur 21 days, or three weeks, following final treatment administration of PROSTVAC or ipilimumab. No further therapy will be administered on study following RP.

    San Francisco, California

  • Predicting the Risk of Failure in Patients Undergoing Radiation Therapy for Localized Prostate Cancer

    open to eligible males ages 18 years and up

    RATIONALE: Gathering information about the Gleason score, prostate-specific antigen (PSA) level, and cancer stage from patients who have undergone radiation therapy for prostate cancer may help doctors predict how patients respond to treatment and help plan the best treatment.

    PURPOSE: This clinical trial is studying the Gleason score, PSA level, and cancer stage in predicting outcome in patients who have undergone radiation therapy for localized prostate cancer.

    San Francisco, California

  • PROMOTE: Identifying Predictive Markers of Response for Prostate Cancer

    open to eligible males ages 18 years and up

    This is a tissue and blood collection protocol requiring image-guided biopsies of metastatic prostate cancer. Whenever possible, a new bone lesion or new/progressing soft tissue lesion will be chosen for biopsy as opposed to radiographically stable lesion. Patients will be enrolled in parallel into one of five patient cohorts based modality of planned or recently initiated systemic therapy, as well as disease setting: (A) Androgen signaling inhibitor, (B) Immunotherapy, (C) Chemotherapy, (D) Targeted therapy, or (E) Castration-sensitive disease. Patients in cohort E will be enrolled in one of two groups: Group 1 (treatment-naïve), and Group 2 (pre-treated) (see previous section for definition). Patients enrolled in Cohorts A-D, as well as Cohort E group 1, will undergo baseline tumor biopsy prior to initiation of next line of systemic therapy. For patients enrolled in Cohort E, group 2, patients will undergo the first tumor biopsy between 6-8 months after first dose of LHRH analogue delivered as treatment for metastatic prostate cancer.

    San Francisco, California

  • Prostate Active Surveillance Study

    open to eligible males ages 21 years and up

    The Prostate Active Surveillance Study (PASS) is a research study for men who have chosen active surveillance as a management plan for their prostate cancer. Active surveillance is defined as close monitoring of prostate cancer with the offer of treatment if there are changes in test results. This study seeks to discover markers that will identify cancers that are more aggressive from those tumors that grow slowly.

    San Francisco, California and other locations

  • Radiologically Guided Biopsies of mCRPC

    open to eligible males ages 18 years and up

    The purpose of this study is to better understand how cancer treatment may affect cancer cells. The research will involve genetic, molecular, cellular, and immunologic experiments using blood and tumor specimens. It is hoped that the information gained from these studies will lead to a greater understanding of castrate-resistant prostate cancer and potentially, improvements in cancer treatment. This is a tissue collection protocol requiring image-guided biopsies of metastatic, castration-resistant prostate cancer (mCRPC). The investigators will focus on enrolling patients with metastatic CRPC who have progressed while receiving novel AR-targeted therapeutics such as abiraterone and enzalutamide. This population of patients was selected because resistance develops relatively rapidly following potent inhibitors of AR activity and the mechanisms of resistance have to be better understood. Without comprehensive analysis of mCRPC tumor, the investigators will never gain a full understanding of the biology driving resistance in human disease and developing rational co-targeting approaches will not be possible.

    San Francisco, California and other locations

  • Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors

    open to all eligible people

    To assess the safety and tolerability of rovalpituzumab tesirine in subjects with specific delta-like protein 3-expressing advanced solid tumors.

    San Francisco, California and other locations

  • S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer

    open to eligible males ages 18 years and up

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

    San Francisco, California and other locations

  • Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer (OSPREY)

    open to eligible males ages 18 years and up

    This study evaluates the safety and diagnostic performance characteristics of 18F-DCFPyL Injection in patients with at least high risk prostate cancer who are planned for radical prostatectomy with lymphadenectomy (Cohort A) or in patients with locally recurrent or metastatic disease willing to undergo biopsy (Cohort B).

    San Francisco, California and other locations

  • Study of MOR209/ES414 in Metastatic Castration-Resistant Prostate Cancer

    open to eligible males

    The study will be conducted in 2 Stages. The primary objective of Stage 1 of the study is to identify the maximum tolerated dose (MTD) of MOR209/ES414 administered intravenously to patients with mCRPC. Secondary objectives are to evaluate the tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, cytokine response, and clinical activity of MOR209/ES414. The primary objective of Stage 2 of the study is to evaluate the clinical activity of MOR209/ES414 in patients that have or have not received prior chemotherapy. Secondary objectives are to further characterize the safety profile, PK, PD, and immunogenicity of MOR209/ES414.

    San Francisco, California and other locations

  • Study to Evaluate 99mTc-MIP-1404 SPECT/CT Imaging in Men With Biopsy Proven Low-Grade Prostate Cancer

    open to eligible males ages 18 years and up

    99mTc-MIP-1404 is a radioactive diagnostic imaging agent indicated for imaging men with newly diagnosed prostate cancer whose biopsy indicates a histopathologic Gleason Score of ≤ 3+4 severity who are candidates for active surveillance and are undergoing voluntary radical prostatectomy (RP) [Cohort A] or routine prostate biopsy [Cohort B]. This Phase 3 study is designed to evaluate the specificity and sensitivity of 99mTc-MIP-1404 SPECT/CT imaging to correctly identify subjects with previously unknown clinically significant prostate cancer.

    San Francisco, California and other locations

  • Trial of Radiotherapy With Leuprolide and Enzalutamide in High Risk Prostate

    open to eligible males ages 18 years and up

    This is a phase II study to evaluate efficacy, safety, toxicity, and feasibility of the addition of enzalutamide to leuprolide for a total duration of 24 months in patients with very high-risk prostate cancer or pelvic node positive disease receiving radiotherapy. Very high-risk prostate cancer is defined as 2 or more of the following characteristics: 1) cT3a/b, 2) PSA ≥20 and <150, 3) Gleason 8-10, and 4) ≥33% core involvement.

    San Francisco, California

  • Web-based Lifestyle Trial Among Men With Prostate Cancer: Prostate 8

    open to eligible males ages 18 years and up

    A randomized controlled trial of a technology-based lifestyle intervention vs. usual care among men with low-risk prostate cancer to determine the acceptability and feasibility of the intervention and the effect of the intervention on behavior change related to exercise, diet, and not smoking.

    San Francisco, California

  • A Study of Ibrutinib as Neoadjuvant Therapy in Localized Prostate Cancer

    Sorry, not yet accepting patients

    Multicenter phase 1/2 study of neoadjuvant Ibrutinib in men with localized prostate cancer undergoing RP as their initial locally directed therapy with curative intent. To assess the immune response following neoadjuvant treatment, tissue from RP specimen will be compared to tissue from core biopsy specimen obtained prior to treatment, with each subject serving as his own control. Immune infiltration will also be compared to a reference cohort of 12 patients who had undergone RP, matched to the study population using the UCSF CAPRA-S score.

  • Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects

    Sorry, not recruiting here

    This is a biomarker preselected, randomized, open-label, multicenter, phase II study in men with metastatic castration resistant prostate cancer (mCRPC). Patients with tumors that have ATM, BRCA1 and/or BRCA2 mutations/deletions/loss of heterozygosity will be randomized in a 1:1:1 fashion to each arm. Patients with mutations in noncanonical DNA repair genes including FANCA, PALB2, RAD51, ERCC3, MRE11, NBN, MLH3, CDK12, CHEK2, HDAC2, ATR, PMS2, GEN1, MSH2, MSH6, BRIP1, or FAM175A defects will be assigned to Arm IV with single agent olaparib.

    San Francisco, California and other locations

  • An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS

    Sorry, not recruiting here

    The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy results in an improvement of metastasis-free survival.

    San Francisco, California and other locations

  • CYT107 After Vaccine Treatment (Provenge) in Patients With Metastatic Hormone-Resistant Prostate Cancer

    Sorry, currently not accepting new patients, but might later

    This randomized phase II trial studies how well glycosylated recombinant human interleukin-7 (CYT107) after vaccine therapy works in treating patients with hormone-resistant prostate cancer that has spread to other areas of the body or has not responded to at least one type of treatment. Biological therapies, such as glycosylated recombinant human interleukin-7, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. It is not yet known whether glycosylated recombinant human interleukin-7 works better with or without vaccine therapy in treating prostate cancer.

    San Francisco, California and other locations

  • Enzalutamide and Metformin Hydrochloride in Treating Patients With Hormone-Resistant Prostate Cancer

    Sorry, not recruiting here

    This phase I trial studies the side effects and best dose of metformin hydrochloride when given together with enzalutamide in treating patients with prostate cancer that has not responded to previous treatment with hormones. Hormone therapy using enzalutamide may fight prostate cancer by lowering the amount of androgens the body makes and blocking the use of androgens by the tumor cells. Metformin hydrochloride, used for diabetes, may also help kill tumor cells. Giving enzalutamide together with metformin hydrochloride may kill more tumor cells.

    San Francisco, California and other locations

  • Hypofractionated Whole Pelvic Radiotherapy of the Prostate

    Sorry, not yet accepting patients

    This is a phase I feasibility study to evaluate the feasibility of hypofractionated whole pelvis radiotherapy in 35 patients with biopsy-proven intermediate- to high-risk prostate cancer as defined by NCCN risk criteria. Patients will have>15% risk of lymph node involvement as defined by the Roach equation 2/3(PSA)+10(Gleason Score-6). Day 0 of the study will be defined as the time of first LHRH/agonist/antagonist injection of hormone therapy. Radiation therapy should begin within 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection. Patients will be followed at 6 weeks and then every 3 months for the first 24 months after completion of radiotherapy in a similar schedule to usual standard of care. A history and physical, PSA, testosterone and EPIC-26 questionnaire will be collected at each visit. Any toxicity according to CTCAE v. 4.0 criteria will be documented. An interim analysis for evaluating acute toxicity (≤90 days) will be performed after the first follow-up visit of the20th patient enrolled on protocol. The trial will be terminated if>30% acute grade 2 or>5% grade 3 or greater toxicity is observed as a result of radiation treatment by CTCAE v. 4.0 criteria. Grade 2 toxicity is defined as a minimal, local or noninvasive intervention. Grade 3 toxicity is defined as a severe or medically significant but not immediately life-threatening event requiring hospitalization or prolongation of hospitalization. Previous studies have demonstrated approximately 30% and 5% incidence of Grade 2 and Grade 3 or greater toxicity, respectively, with conventionally fractionated radiotherapy followed by brachytherapy.

  • INTense Exercise foR surVivAL Among Men With Metastatic Castrate-Resistant Prostate Cancer

    Sorry, not recruiting here

    A Study to determine if high intensity aerobic and resistance training plus psychosocial support increases overall survival compared to psychosocial support alone in patients with metastatic castrate-resistant prostate cancer.

    San Francisco, California and other locations

  • Pembrolizumab in Combination With Intratumoral SD-101 Therapy

    Sorry, not yet accepting patients

    This is a non-comparative open-label multicenter Phase 2 clinical trial combining definitive prostatic radiotherapy (RT) and pembrolizumab with or without intratumoral SD-101 in patients with newly diagnosed hormone-naive oligometastatic prostate cancer.

    San Francisco, California and other locations

  • Safety & Immunogenicity of JNJ-64041809, a Live Attenuated Double-deleted Listeria Immunotherapy, in Participants With Metastatic Castration-resistant Prostate Cancer

    Sorry, currently not accepting new patients, but might later

    The purpose of this study is to find and evaluate the recommended Phase 2 dose (RP2D) of JNJ-64041809, a live attenuated double deleted (LADD) Listeria monocytogenes (bacteria in which two virulence genes, which encode molecules that help cause disease, have been removed) when administered intravenously to participants with metastatic castration-resistant prostate cancer (mCRPC).

    San Francisco, California and other locations

  • Safety and Tolerability of Atezolizumab (ATZ) in Combination With Radium-223 Dichloride (R-223-D) in Metastatic Castrate-Resistant Prostate Cancer (CRPC) Progressed Following Treatment With an Androgen Pathway Inhibitor

    Sorry, not recruiting here

    This study is designed to assess the safety and tolerability of atezolizumab when given in combination with radium-223 dichloride in participants with metastatic CRPC who have progressed after treatment with an androgen pathway inhibitor. An adaptive design is planned to first investigate the tolerability with concurrent administration (both treatments to begin in Cycle 1). However, if the combination is not tolerated, additional cohorts may be enrolled to evaluate the tolerability of radium-223 dichloride (to begin in Cycle 1) with delayed atezolizumab (to begin in Cycle 2 and/or 3).

    San Francisco, California and other locations

  • Study Evaluating the Addition of Pembrolizumab to Radium-223 in mCRPC

    Sorry, not yet accepting patients

    This research study is studying the safety and tolerability of an investigational combination of drugs, radium-223 plus pembrolizumab as a possible treatment for castration-resistant prostate cancer. The interventions involved in this study are: - Radium-223 - Pembrolizumab

    San Francisco, California and other locations

  • A Phase 1 Study of AM0010 in Patients With Advanced Solid Tumors

    Sorry, in progress, not accepting new patients

    This is a first-in-human, open-label, dose escalation study to evaluate the safety and tolerability of AM0010 in patients with advanced solid tumors, dosed daily subcutaneously as a monotherapy or in combination with chemotherapy or immunotherapy.

    San Francisco, California and other locations

  • A Phase II Study of Increased-Dose Abiraterone Acetate in Patients With Castration Resistant Prostate Cancer

    Sorry, in progress, not accepting new patients

    The purpose of this study is to find out what effects, good and/or bad,an increased dose of Abiraterone Acetate in combination with prednisone has on patients and their prostate cancer. This study will investigate whether an increased-dose (2,000mg daily) is safe and potentially effective when given to patients whose cancer has grown while taking the standard dose.

    San Francisco, California and other locations

  • A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer

    Sorry, in progress, not accepting new patients

    The purpose of this study is to investigate potential drug-drug interaction (DDI) between JNJ-56021927 and abiraterone acetate and between JNJ-56021927 and prednisone, determine safety of the combination and evaluate in a descriptive manner the efficacy in these participants. It will also, potentially provide dosing recommendations for abiraterone acetate in future studies when combined with JNJ-56021927.

    San Francisco, California and other locations

  • Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer

    Sorry, in progress, not accepting new patients

    Primary Objective: - To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m^2 (Arm A) or 20 mg/m^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy. Secondary Objectives: - To evaluate safety in the 3 treatment arms. - To compare efficacy of cabazitaxel at 20 mg/m^2 and 25 mg/m^2 to docetaxel for: - Progression Free Survival (PFS) (RECIST 1.1) - Tumor progression free survival (RECIST 1.1) - Tumor response in participants with measurable disease (RECIST 1.1), - PSA response - PSA-Progression free survival (PSA-PFS). - Pain response in participants with stable pain at baseline - Pain progression free survival - Time to occurrence of any skeletal related events (SRE) - To compare Health-Related Quality of Life (HRQL). - To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.

    San Francisco, California and other locations

  • Collection of Patient-Reported Symptoms and Performance Status Via the Internet

    Sorry, in progress, not accepting new patients

    This pilot clinical trial studies how well using the internet to collect symptoms and the ability to carry out daily activities works in patients with enrolled on Cancer and Leukemia Group B (CALGB) studies. A study that evaluates a patient's ability to use a clinic waiting room computer to report their symptoms and their ability to carry out daily activities may help doctors understand a patient's use of a computer to report symptoms.

    San Francisco, California and other locations

  • Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) for Localized Prostate Cancer

    Sorry, in progress, not accepting new patients

    This study will primarily compare the effectiveness of surgery and radiation for localized prostate cancer, the most common male cancer. It will focus on modern technologies and control for differences in patients and treatments that may affect both cancer-related and patient-reported outcomes (such as impotence and incontinence). By figuring out what treatments "work best, in which patients and in whose hands", it will help men with prostate cancer make better decisions regarding their care.

    San Francisco, California and other locations

  • CyberKnife Radiosurgery For Low & Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry

    Sorry, in progress, not accepting new patients

    The purpose of this study is to investigate the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer and to evaluate the effects of this treatment on the quality of life over time.

    Fresno, California and other locations

  • Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance

    Sorry, in progress, not accepting new patients

    RATIONALE: Eating a diet high in vegetables may slow down disease progression in patients with prostate cancer.

    PURPOSE: This randomized clinical trial is studying how well diet works in altering disease progression in patients with prostate cancer on active surveillance.

    San Francisco, California and other locations

  • Effectiveness of Open and Robotic Prostatectomy

    Sorry, in progress, not accepting new patients

    Prostate cancer is the most common cancer in American men. Surgical removal of the entire prostate (prostatectomy) is one option among the various ways to treat prostate cancer. The use of robot assistance for prostatectomy has become common place, but its effectiveness has not been compared to standard open prostatectomy in trials carried out at more than one medical institution in which participants are identified and followed forward in time. Robot assisted and standard open prostatectomy health related quality of life (HRQOL) outcomes have not been compared in a prospective, multi-centered study. Prostatectomy can have side effects that can change with time. This research study seeks to determine how common and how long-lasting such side effects are; to find out what features of individual men's cancers and what features of the treatments affect those side effects. This study also seeks to identify factors that affect the quality of prostate cancer care by looking at how satisfied men are with their prostate cancer care. Through these findings, this study aims to allow treatment side effects to be anticipated more accurately for individual patients, and to provide a means for determining the quality of prostate care.

    San Francisco, California and other locations

  • Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients With Castration-Resistant Metastatic Prostate Cancer

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    This randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone, and prednisone in treating patients with castration-resistant metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens made by the body.

    San Francisco, California and other locations

  • Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer

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    This randomized phase III trial studies gemcitabine hydrochloride, cisplatin, and bevacizumab to see how well they work compared with gemcitabine hydrochloride and cisplatin in treating patients with urinary tract cancer that has spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether gemcitabine hydrochloride and cisplatin are more effective when given with or without bevacizumab in treating patients with urinary tract cancer.

    San Francisco, California and other locations

  • Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

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    RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone therapy and radiation therapy is more effective for prostate cancer.

    PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer.

    San Francisco, California and other locations

  • Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer

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    RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as steroid 17alpha-monooxygenase TAK-700, when used with other hormone therapy, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for prostate cancer when combined with hormone therapy. Studying quality-of-life in patients having cancer treatment may help identify the intermediate- and long-term effects of treatment on patients with prostate cancer.

    PURPOSE: This randomized phase III trial is studying the use of hormone therapy, including TAK-700, together with radiation therapy in treating patients with prostate cancer.

    San Francisco, California and other locations

  • Hyperpolarized C-13 Pyruvate as a Biomarker in Patients With Advanced Solid Tumor Malignancies

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    This is a single center prospective imaging study investigating the utility of hyperpolarized C-13 pyruvate as a Biomarker of PI3K/mTOR pathway inhibition in patients with advanced solid tumor malignancies. The current protocol will serve as a companion imaging biomarker study paired with therapeutic trials of PI3K/mTOR pathway inhibitors (e.g. CUDC-907, BYL719), as well as a stand-alone protocol for patients treated with standard-of-care therapies inhibiting the PI3K/mTOR signaling pathway (eg. everolimus).

    San Francisco, California

  • Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer

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    RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining interstitial brachytherapy with external-beam radiation therapy may kill more tumor cells. It is not yet known whether interstitial brachytherapy is more effective with or without external-beam radiation therapy in treating prostate cancer.

    PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial brachytherapy with or without external-beam radiation therapy in treating patients who have prostate cancer.

    San Francisco, California and other locations

  • Ipilimumab and Sargramostim in Treating Patients With Metastatic Prostate Cancer

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    This phase I trial is studying the side effects and best dose of ipilimumab when given with sargramostim in treating patients with metastatic prostate cancer. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system kill more tumor cells.

    San Francisco, California

  • Phase I Cabazitaxel, Mitoxantrone, and Prednisone Metastatic Castration-Resistant Prostate Cancer

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    The purpose of this study is to test the safety of cabazitaxel, mitoxantrone, and prednisone (CAMP) in combination at different dose levels and to determine the highest dose that does not cause bad side effects. The investigators want to find out what effects, good and/or bad, CAMP has on patients and their metastatic castration-resistant prostate cancer.

    San Francisco, California and other locations

  • Pilot Study of a Catheter-based Ultrasound Hyperthermia System

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    RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Ultrasound energy may be able to kill tumor cells by heating up the tumor cells without affecting the surrounding tissue. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving ultrasound hyperthermia therapy after implant radiation therapy may kill more tumor cells.

    PURPOSE: This clinical trial is studying ultrasound hyperthermia therapy to see how well it works after implant radiation therapy in treating patients with Stage III/IV cancer of the cervix or prostate cancer with a rising prostate specific antigen (PSA) after prior local therapy.

    San Francisco, California

  • Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer

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    RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, and luteinizing hormone-releasing hormone agonist, may lessen the amount of androgens made by the body. It is not yet known which regimen of radiation therapy with or without androgen-deprivation therapy is more effective for prostate cancer.

    PURPOSE: This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer.

    San Francisco, California and other locations

  • Radiation Therapy in Treating Patients With Prostate Cancer

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    RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Given radiation therapy in different ways may kill more tumor cells.

    PURPOSE: This randomized phase II trial studies radiation therapy to see how well it works in treating patients with prostate cancer.

    San Francisco, California and other locations

  • Radiation Therapy in Treating Patients With Stage II Prostate Cancer

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    RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving hypofractionated radiation therapy (higher doses over a shorter period of time), may be less costly with fewer side effects and just as effective in treating prostate cancer.

    PURPOSE: This randomized phase III trial is studying several different radiation therapy regimens to compare how well they work in treating patients with stage II prostate cancer.

    San Francisco, California and other locations

  • Radiation Therapy in Treating Patients With Stage II Prostate Cancer

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    RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating stage II prostate cancer.

    PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of specialized radiation therapy in treating patients who have stage II prostate cancer.

    San Francisco, California and other locations

  • Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer

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    RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without androgen-deprivation therapy in treating patients with prostate cancer.

    PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.

    San Francisco, California and other locations

  • Radiation Therapy With or Without Bicalutamide in Treating Patients With Stage II, Stage III, or Recurrent Prostate Cancer

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    RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer.

    PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II, stage III, or recurrent prostate cancer and elevated PSA levels following radical prostatectomy.

    San Francisco, California and other locations

  • Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 in Castration-Resistant Prostate Cancer (CRPC)

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    The purpose of this study is to assess the safety and activity of ARN-509 in men with advanced castration resistant prostate cancer. Patients will first be enrolled into Phase 1 of the study to identify a tolerable dose for the Phase 2 portion of the study. In the Phase 2, 3 different cohorts of patients will be enrolled to evaluate the safety and activity of ARN-509.

    San Francisco, California and other locations

  • Selinexor (KPT-330) in Patients With Metastatic Castration-Resistant Prostate Cancer and Prior Therapy With Abiraterone and/or Enzalutamide

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    Abiraterone acetate is now considered the standard of care for patients with metastatic castrate-resistant prostate cancer (mCRPC) in the pre-chemotherapy setting. Patients with primary or acquired abiraterone resistance typically have rapidly progressive, refractory disease for which limited treatment options are available. The development of new therapies in mCRPC requires a focus on patients with primary or acquired resistance to abiraterone. Patients with abiraterone-refractory mCRPC have a poor prognosis overall with median survival after progression of disease at approximately 19 months. While chemotherapy is a standard approach in this setting, it is refused by many patients and clinicians due to toxicity concerns. Selinexor is a first in class Selective Inhibitor of Nuclear Export (SINE) that specifically blocks the karyopherin protein Exportin 1 (XPO1/Exportin 1). XPO1 is a key regulatory protein responsible for the nuclear export leading to functional inactivation of tumor suppressor proteins (TSPs) and is up-regulated 2-4 fold in all cancers studied to date. Selinexor, given orally, has demonstrated potent anti-cancer activity in animal models of prostate cancer including inhibition of PC3 driven bone metastasis.The goal of this trial is to evaluate the potential for a progression free survival benefit associated with Selinexor administration in patients with abiraterone-refractory mCRPC. Single agent phase II open label study of Selinexor in patients with mCRPC with prior therapy with standard hormone ablation agents and abiraterone. A maximum of 54 evaluable patients will be accrued for this study, provided the early stopping criteria are not met. The starting dose for all patients will be an oral dose of 65 mg/m2, given twice per week at least 48 hours apart. Tablets for Selinexor oral administration will be supplied in two (2) strengths: 10 and 25 mg of active ingredient per tablet. Dexamethasone will be coadministered at a dose of 2 mg twice daily on the day of dosing and the day after. Patients will be followed for 30 days after completion of treatment or removal from study, or until death, whichever occurs first. Patients removed from study for unacceptable treatment related adverse event(s) will be followed until resolution or stabilization of all treatment related adverse events to Grade 2 or lower.

    San Francisco, California

  • Study to Assess Safety and Tolerability of Oral CC-115 for Patients With Advanced Solid Tumors, and Hematologic Malignancies.

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    The main purpose of this first human study with CC-115 is to assess the safety and action of a new class of experimental drug (dual DNA-PK and TOR kinase inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor types for later-stage clinical trials. The bioavailability of tablet and capsule formulations under fasting and fed conditions will also be evaluated in some patients.

    San Francisco, California and other locations

  • Ultrasound-Guided Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer Previously Treated With External-Beam Radiation Therapy

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    RATIONALE: Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells.

    PURPOSE: This phase II trial is studying the side effects and how well ultrasound-guided implant radiation therapy works in treating patients with locally recurrent prostate cancer previously treated with external-beam radiation therapy.

    Fresno, California and other locations