Treatment Clinical Trials for Prostate Cancer

Clinical trials are research studies that involve people. The clinical trials on this list are for prostate cancer treatment. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-25 of 315
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  • Targeted Therapy Directed by Genetic Testing in Treating Patients with Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

    This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
    Location: 1209 locations

  • Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) with One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors

    This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that have spread to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.
    Location: 544 locations

  • Comparing the Outcome of Standard Systemic Therapy Only versus Standard Systemic therapy with either Surgery or Radiation Therapy, for Patients with Advanced Prostate cancer

    This phase III trial compare the effects of adding definitive treatment (either radiation therapy or prostate removal surgery) to standard systemic therapy in treating patients with prostate cancer that has spread to other places in the body (advanced). Removing the prostate by either surgery or radiation therapy in addition to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.
    Location: 261 locations

  • Antiandrogen Therapy and Radiation Therapy with or without Docetaxel in Treating Patients with Prostate Cancer That Has Been Removed by Surgery

    This randomized phase II / III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, 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. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.
    Location: 235 locations

  • Stereotactic Body Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients with Stage IIA-B Prostate Cancer

    This randomized phase III trial studies how well stereotactic body radiation therapy works compared to intensity-modulated radiation therapy in treating patients with stage IIA-B prostate cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Stereotactic body radiation therapy may work better in treating patients with prostate cancer.
    Location: 224 locations

  • Testing the Addition of the Drugs, Apalutamide and Abiraterone with Prednisone, to the Usual Hormone Therapy and Radiation Therapy after Surgery for Prostate Cancer

    This phase III trial studies whether adding apalutamide, abiraterone acetate, and prednisone to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or reduce the growth of prostate cancer cell growth by blocking the attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping the entrance of a key into its lock. Abiraterone acetate blocks some of the enzymes needed for androgen production and may cause the death of prostate cancer cells dependent on androgen for their growth. Prednisone may help abiraterone acetate work better by making tumor cells more sensitive to the drug. Adding apalutamide and abiraterone acetate with prednisone to the usual hormone therapy and radiation therapy after surgery may stabilize prostate cancer and prevent it from spreading and extend time without disease spreading compared to the usual approach.
    Location: 177 locations

  • Two Studies for Patients with High Risk Prostate Cancer Testing Less Intense Treatment for Patients with a Low Gene Risk Score and Testing a More Intense Treatment for Patients with a High Gene Risk Score, The PREDICT-RT Trial

    This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Abiraterone acetate may help fight prostate cancer by lowering the amount of testosterone made by the body. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding abiraterone acetate and apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score.
    Location: 78 locations

  • Docetaxel with or without Radium Ra 223 Dichloride in Treating Patients with Metastatic Castration-Resistant Prostate Cancer

    This phase III trial studies docetaxel and radium Ra 223 dichloride to see how well it works compared with docetaxel alone in treating patients with prostate cancer that has spread to other places in the body, despite the surgical removal of the testes or medical intervention to block androgen production (metastatic castration-resistant). Chemotherapy drugs, such as docetaxel and radium Ra 223 dichloride, 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. It is not known whether docetaxel with or without radium Ra 223 dichloride works better at treating metastatic castration-resistant prostate cancer.
    Location: 42 locations

  • Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) after Surgery for Men with High-Risk Prostate Cancer, The ERADICATE Study

    This phase III trial compares the effect of adding darolutamide to ADT versus ADT alone after surgery for the treatment of high-risk prostate cancer. ADT reduces testosterone levels in the blood. Testosterone is a hormone made mainly in the testes and is needed to develop and maintain male sex characteristics, such as facial hair, deep voice, and muscle growth. It also plays a role in prostate cancer development. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. Giving darolutamide with ADT may work better in eliminating or reducing the size of the cancer and / or prevent it from returning compared to ADT alone in patients with prostate cancer.
    Location: 40 locations

  • A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer

    This study is a large, prospective, pragmatic, controlled comparison of patient-centric outcomes [quality of life (QOL), toxicity, and disease control] between parallel cohorts of men with prostate cancer treated simultaneously at proton therapy facilities and at geographically similar conventional (photon-based) radiation facilities using intensity-modulated radiation therapy (IMRT) techniques.
    Location: 30 locations

  • Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors

    This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with multiple tumor types, including advanced urothelial carcinoma (UC) (including bladder, renal pelvis, ureter, urethra), renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC), non-small-cell lung cancer (NSCLC), triple negative breast cancer (TNBC), ovarian cancer (OC), endometrial cancer (EC), hepatocellular cancer (HCC), gastric cancer / gastroesophageal junction cancer / lower esophageal cancer (GC / GEJC / LEC), colorectal cancer (CRC), head and neck (H&N) cancer, and differentiated thyroid cancer (DTC). The study consists of two stages: in the Dose Escalation Stage, an appropriate recommended cabozantinib dose for the combination with standard dosing regimen of atezolizumab will be established; in the Expansion Stage, tumor-specific cohorts will be enrolled in order to further evaluate the safety and efficacy of the combination treatment in these tumor indications. Three exploratory single-agent cabozantinib (SAC) cohorts may also be enrolled with UC, NSCLC, or CRPC subjects. One exploratory single-agent atezolizumab (SAA) cohort may also be enrolled with CRPC subjects. Subjects enrolled in the SAC cohorts and SAA cohort may receive combination treatment with both cabozantinib and atezolizumab after they experience radiographic progressive disease per the Investigator per RECIST 1.1. Due to the nature of this study design, some tumor cohorts may complete enrollment earlier than others.
    Location: 28 locations

  • A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer

    This is a randomized, open-label, three-arm, phase 3 study in men with biochemically recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.
    Location: 26 locations

  • Randomized Trial of Topotecan With M6620, an ATR Kinase Inhibitor, in Small Cell Lung Cancers and Small Cell Cancers Outside of the Lungs

    This phase II trial studies how well M6620 works when given in combination with topotecan hydrochloride (topotecan) compared with topotecan alone in treating patients with small cell lung cancer that has come back (relapsed), or small cell cancer that arises from a site other than the lung (extrapulmonary). Drugs used in chemotherapy, such as topotecan hydrochloride, work by damaging the DNA (deoxyribonucleic acid) in tumor cells, causing those cells to die and the tumor to shrink. However, some tumor cells can become less affected by chemotherapy because they have ways to repair the damaged DNA. The addition of M6620 could help topotecan hydrochloride shrink the cancer and prevent it from returning by blocking enzymes needed for DNA repair.
    Location: 26 locations

  • Olaparib and Radium Ra 223 Dichloride in Treating Men with Metastatic Castration-Resistant Prostate Cancer That Has Spread to the Bone

    This phase I / II trial studies the best dose and side effects of olaparib and how well it works with radium Ra 223 dichloride in treating patients with castration-resistant prostate cancer that has spread to the bone and other places in the body (metastatic). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Radioactive drugs, such as radium Ra 223 dichloride, may carry radiation directly to tumor cells and not harm normal cells. Giving olaparib and radium Ra 223 dichloride may help treat patients with castration-resistant prostate cancer.
    Location: 17 locations

  • Muscadine Plus in Treating Rising PSA Levels in Men Carrying a Specific Gene Variant (Alanine / Alanine SOD2 Genotype) Following Initial Therapy for Prostate Cancer

    Muscadine plus (MPX) is made from Muscadine grape skins that have been dried and ground into powder. Studies in the laboratory suggest the grape skins contain natural compounds that slow the growth of prostate cancer. About one out of every four men has the specific deoxyribonucleic acid (DNA) (Alanine / Alanine SOD2 Genotype) that might make them more responsive to MPX. Prostate specific antigen (PSA) is a protein produced by the cells of the prostate gland. PSA test can monitor patients with a history of prostate cancer to see if the cancer has come back. This phase III trial studies how well MPX works in treating rising prostate-specific antigen levels (PSA) in men, following initial therapy for prostate cancer compared to those not taking MPX.
    Location: 17 locations

  • Study of NGM120 in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy

    Study of NGM120 in subjects with advanced solid tumors and pancreatic cancer.
    Location: 15 locations

  • A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

    The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) based on conventional imaging, as compared to placebo plus ADT.
    Location: 16 locations

  • Abiraterone Acetate, Olaparib, and Prednisone in Treating Patients with Metastatic Castration-Resistant Prostate Cancer with DNA Repair Defects

    This partially randomized phase II trial studies how well abiraterone acetate, olaparib, and prednisone work in treating patients with prostate cancer that is resistant to hormones, has spread to other places in the body, and has deoxyribonucleic acid (DNA) repair defects. Abiraterone acetate and olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving abiraterone acetate, olaparib, and prednisone may work better in treating patients with prostate cancer.
    Location: 15 locations

  • A Study of ASP1948, Targeting an Immune Modulatory Receptor as a Single Agent and in Combination With a PD-l Inhibitor (Nivolumab or Pembrolizumab) in Subjects With Advanced Solid Tumors

    The purpose of this study is to evaluate the tolerability and safety profile of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumors; characterize the pharmacokinetic profile of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab and determine the recommended Phase 2 dose (RP2D) of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab. This study will also evaluate the antitumor effect of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab.
    Location: 13 locations

  • Radiation Medication (Radium-223 dichloride) versus Radium-223 dichloride plus Radiation Enhancing Medication (M3814) versus Radium-223 dichloride plus M3814 plus Avelumab (a type of immunotherapy) for Advanced Prostate Cancer Not Responsive to Hormonal Therapy

    This phase I / II trial studies the best dose of M3814 when given together with radium-223 dichloride or with radium-223 dichloride and avelumab and to see how well they work in treating patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). M3814 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs, such as radium-223 dichloride, may carry radiation directly to tumor cells and not harm normal cells. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to find out the better treatment between radium-223 dichloride alone, radium-223 dichloride in combination with M3814, or radium-223 dichloride in combination with both M3814 and avelumab, to lower the chance of prostate cancer growing or spreading in the bone, and if this approach is better or worse than the usual approach for advanced prostate cancer not responsive to hormonal therapy.
    Location: 14 locations

  • Surgical Removal of Prostate Tumor and Antiandrogen Therapy with or without Docetaxel in Treating Men with Newly Diagnosed Metastatic Prostate Cancer

    This randomized phase II trial studies how well surgical removal of the prostate and antiandrogen therapy with or without docetaxel work in treating men with newly diagnosed prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Antiandrogen therapy may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel 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. Surgery, antiandrogen therapy and docetaxel may work better in treating participants with prostate cancer.
    Location: 7 locations

  • CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers

    This is a Phase 1 / 1b open-label, dose escalation and dose expansion study of CPI-006, a humanized monoclonal antibody (mAb) targeting the CD73 cell-surface ectonucleotidase in adult subjects with select advanced cancers. CPI-006 will be evaluated as a single agent, in combination with ciforadenant (an oral adenosine 2A receptor antagonist), in combination with pembrolizumab (an anti-PD1 antibody), and in combination with ciforadenant and pembrolizumab.
    Location: 13 locations

  • Study of I-131-1095 Radiotherapy in Combination With Enzalutamide in Patients With Metastatic Castration-resistant Prostate Cancer Who Are Chemotherapy Naive and Have Progressed on Abiraterone

    This is a multicenter, randomized, controlled, phase 2 clinical trial designed to evaluate the safety and efficacy of I-131-1095 radiotherapy in combination with enzalutamide compared to enzalutamide alone in patients with prostate-specific membrane antigen (PSMA)-avid metastatic castration resistant prostate cancer (mCRPC) who have progressed on abiraterone. Patients must be chemotherapy-naive and must be ineligible or refuse to receive taxane-based chemotherapy at time of study entry. PSMA-avidity will be determined by central imaging review based on assessment of 18F-DCFPyL PET / CT imaging during screening. Eligible patients meeting the PSMA-avidity criteria will be randomized in a 2:1 ratio to receive either I-131-1095 in combination with enzalutamide (80 subjects) or enzalutamide alone (40 subjects). Patients will be followed for efficacy and safety assessments during a 12-month Randomized Treatment period. Patients will be followed for an additional year for safety and survival status. Safety data will be monitored by an independent Data Monitoring Committee and the sponsor.
    Location: 13 locations

  • Apalutamide, Abiraterone Acetate, and Prednisone in Treating Patients with Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

    This phase II trial studies how well apalutamide, abiraterone acetate, and prednisone work in treating patients with castration-resistant prostate cancer that has spread to other parts of the body and have not had prior treatment with chemotherapy. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. It is believed apalutamide may help stop or slow the growth of prostate cancer cell growth by blocking the male sex hormones. Abiraterone acetate is a drug that blocks the remaining or residual male sex hormones in the body that may be helping prostate cancer to grow. Prednisone may help abiraterone acetate work better by making tumor cells more sensitive to the drug. Giving apalutamide, abiraterone acetate, and prednisone together may work better in treating patients with prostate cancer.
    Location: 12 locations

  • A Randomized Trial of Pembrolizumab & Radiotherapy Versus Radiotherapy in High-Risk Soft Tissue Sarcoma of the Extremity

    This is an open-label, multi-institutional phase II randomized study comparing neoadjuvant radiotherapy followed by surgical resection to neoadjuvant pembrolizumab with concurrent radiotherapy, followed by surgical resection and adjuvant pembrolizumab. The total duration of pembrolizumab will be one year in the experimental arm.
    Location: 13 locations


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