Clinical Trials Using Enzalutamide

Clinical trials are research studies that involve people. The clinical trials on this list are studying Enzalutamide. 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 44
1 2 Next >

  • Testosterone Therapy or Enzalutamide in Treating Patients with Asymptomatic Castration Resistant Metastatic Prostate Cancer

    This randomized phase II trial compares testosterone therapy with the current standard treatment, enzalutamide, to see how well they work in treating patients with prostate cancer that is not causing signs or symptoms, has not responded to hormone therapy, and has spread to other parts of the body. Testosterone replacement therapy may help stop tumor cell growth and shrink tumors. Androgen can cause the growth of prostate cancer cells. Antihormone therapy, such as enzalutamide, may fight prostate cancer by blocking the cancer cells from using androgen. It is not yet known whether testosterone therapy is more effective than enzalutamide in treating patients with prostate cancer that has not responded to hormone therapy.
    Location: 15 locations

  • ProSTAR: A Study Evaluating CPI-1205 in Patients With Metastatic Castration Resistant Prostate Cancer

    This is a two-arm, open label Phase 1b / 2 study with an oral administration of CPI-1205 in combination with either enzalutamide or abiraterone / prednisone in male patients with metastatic Castration Resistant Prostate Cancer. This study is designed to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) based on safety, tolerability, pharmacokinetic, and efficacy profiles of CPI-1205 in combination with either enzalutamide or abiraterone / prednisone. Following determination of MTD and RP2D will proceed to phase 2. Patients in phase 2 will receive CPI-1205 at the RP2D in combination with either enzalutamide or abiraterone / prednisone vs either enzalutamide or abiraterone / prednisone as a control arm.
    Location: 15 locations

  • A Study of Rucaparib Versus Physician's Choice of Therapy in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

    The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.
    Location: 13 locations

  • Salvage Radiation Therapy with or without Enzalutamide in Treating Patients with High-Risk PSA-Recurrent Prostate Cancer after Radical Prostatectomy

    This randomized phase II trial studies how well salvage radiation therapy with or without enzalutamide works in treating patients with prostate cancer with high-risk prostate cancer with a rising prostate-specific antigen (PSA) after surgery to remove the entire prostate and some of the tissue around it (radical prostatectomy). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Enzalutamide may stop the growth of prostate cancer by blocking an important protein that keeps prostate cancer cells alive and may make prostate cells more resistant to radiation therapy. It is not yet known whether salvage radiation therapy is more effective with or without enzalutamide in treating prostate cancer.
    Location: 9 locations

  • Dose Escalation and Dose Expansion Study of GSK525762 in Combination With Androgen Deprivation Therapy and Other Agents in Subjects With Castrate-resistant Prostate Cancer

    The study aims to evaluate the combination of GSK525762 with other agents that have been shown to be effective in the treatment of CRPC or metastatic CRPC, including approved agents (e.g., abiraterone, enzalutamide) as well as investigational agents for mCRPC that have proven to show efficacy and can be combined based on complimentary mechanism of action. As a first step, the combination of GSK525762 will be evaluated as a combination with abiraterone or enzalutamide in men with metastatic or advanced castrate-resistant prostate cancer who have progressed on at least one line of prior androgen receptor (AR)-targeted therapy. This study is designed to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) based on safety, tolerability, pharmacokinetic, and efficacy profiles of GSK525762 in combination with either abiraterone (Arm A) or enzalutamide (Arm B). Arm A and Arm B will further have 2 cohorts: A1, A2 and B1, B2 respectively based on prior lines of therapy (L2 [chemo-naive subjects treated with a second androgen-deprivation therapy] and Lx [subjects treated with both prior androgen-deprivation therapy and chemotherapy]). During dose escalation, both the treatment arms (A and B) will follow a modified Toxicity Probability Interval (mTPI) design. Approximately 130 subjects will be enrolled worldwide in this study. Subjects from both dose escalation and dose expansion may be combined to reach 30 subjects. The total duration of study will be approximately 2 to 3 years. A subject will be considered to have completed the study if they are followed until death.
    Location: 8 locations

  • Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365 / KEYNOTE-365)

    The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC). There will be four cohorts in this study: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, Cohort C will receive pembrolizumab + enzalutamide, and cohort D will receive pembrolizumab + abiraterone + prednisone. Outcome measures will be assessed individually for each cohort.
    Location: 8 locations

  • Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

    This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide.
    Location: 8 locations

  • Enzalutamide, Carboplatin, and Paclitaxel in Treating Patients with Stage III-IV or Recurrent Endometrioid Endometrial Cancer

    This phase II trial studies how well enzalutamide, carboplatin, and paclitaxel work in treating patients with endometrioid endometrial cancer that is stage III-IV or has come back. Androgens can cause the growth of endometrioid endometrial cancer. Antihormone therapy, such as enzalutamide may lessen the amount of androgen made by the body. Drugs used in chemotherapy, such as carboplatin and paclitaxel, 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 enzalutamide, carboplatin, and paclitaxel may work better in treating patients with endometrioid endometrial cancer.
    Location: 6 locations

  • Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010 / KEYLYNK-010)

    The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5'-diphosphoribose poly(ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy. The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to: 1. Overall Survival (OS) and 2. Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR)
    Location: 6 locations

  • Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641 / KEYNOTE-641)

    The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review.
    Location: 5 locations

  • An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer

    The purpose of this study is to assess the safety and efficacy of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate cancer that has spread.
    Location: 4 locations

  • Enzalutamide and DNA-PK / TOR Kinase Inhibitor CC-115 in Treating Patients with Metastatic Castration-Resistant Prostate Cancer

    This phase Ib trial studies the side effects and best dose of deoxyribonucleic acid-dependent protein kinase (DNA-PK) / target of rapamycin (TOR) kinase inhibitor CC-115 when given together with enzalutamide in treating patients with castration-resistant prostate cancer that has spread to other places in the body. DNA-PK / TOR kinase inhibitor CC-115 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Enzalutamide is an androgen receptor inhibitor that may slow down the growth of prostate cancer by blocking the action of the male hormone testosterone and other male hormones called androgens. Giving DNA-PK / TOR kinase inhibitor CC-115 and enzalutamide may work better in treating patients with castration-resistant prostate cancer.
    Location: 4 locations

  • A Phase 1 Clinical Study of AZD4635 in Patients With Advanced Solid Malignancies

    This is a Phase 1, open-label, multicenter study of continuous oral dosing of AZD4635 administered to patients with advanced solid malignancies. Dosing will be escalated until a maximum-tolerated dose (MTD) is determined in patients. The MTD will be defined by dose-limiting toxicity. Other dosing schedules may be evaluated based on the emerging PK and safety data. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of the patients. The primary objectives of this study are to: - Investigate the safety and tolerability of AZD4635 monotherapy when given orally (PO) to patients with advanced solid malignancies. - Investigate the safety, tolerability, and pharmacokinetics (PK) of AZD4635 monotherapy capsule formulation when given to patients with advanced solid malignancies. - Investigate the safety and tolerability of AZD4635 PO when given in combination with durvalumab, durvalumab plus oleclumab, or docetaxel to patients with advanced solid malignancies and to investigate the safety and tolerability of AZD4635 in combination with abiraterone acetate or enzalutamide in patients with mCRPC. - Define the maximum-tolerated dose (MTD) of AZD4635 in combination with durvalumab. - Define the recommended Phase 2 dose (RP2D) of AZD4635 in combination with abiraterone acetate or enzalutamide. - Determine the safety, tolerability, and immune effects of AZD4635 when administered in combination with durvalumab to patients with non-small cell lung cancer (NSCLC) who have previously received immunotherapy (Phase 1b portion). - Investigate the safety and tolerability of AZD4635 capsule formulation in combination with durvalumab and oleclumab when given to patients with mCRPC or advanced solid tumor malignancy. - Define the RP2D of AZD4635 capsule formulation in combination with durvalumab and oleclumab when given to patients with mCRPC or advanced solid tumor malignancy. - Investigate the safety and tolerability of AZD4635 capsule formulation in combination with docetaxel when given to patients with mCRPC or advanced solid tumor malignancy. - Define the RP2D of AZD4635 capsule formulation in combination with docetaxel when given to patients with mCRPC or advanced solid tumor malignancy.
    Location: 4 locations

  • Enzalutamide with or without Ribociclib in Treating Patients with Metastatic Castrate-Resistant, Chemotherapy Naive Prostate Cancer That Retains Retinoblastoma Expression

    This partially randomized phase Ib / II trial studies the side effects and best dose of ribociclib when given with enzalutamide and to see how well they work compared to enzalutamide alone in treating patients with castrate-resistant prostate cancer that has spread from the primary site (place where it started) to other places in the body (metastatic), is chemotherapy naive, and retains retinoblastoma expression. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether enzalutamide works better when given with or without ribociclib in treating patients with prostate cancer.
    Location: 4 locations

  • Enzalutamide with or without Galunisertib in Treating Patients with Metastatic Castrate Resistant Prostate Cancer

    This randomized phase II trial studies how well giving enzalutamide with or without galunisertib works in treating patients with prostate cancer that has spread to other places in the body (metastatic) and keeps growing even when the amount of testosterone in the body is reduced to very low levels (castrate-resistant). Enzalutamide may help slow or stop the growth of prostate cancer cells by blocking testosterone production in the body. Some tumors need growth factors, which are made by the body's white blood cells, to keep growing. Galunisertib may interfere with growth factors and help cause tumor cells to die. It is not yet known whether enzalutamide works better alone or with galunisertib in treating patients with castrate resistant prostate cancer.
    Location: 4 locations

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

    This randomized phase II trial studies how well enzalutamide with or without radium Ra 223 dichloride in treating patients with castration-resistant prostate cancer that has spread to other places in the body. Enzalutamide is an androgen receptor inhibitor that may slow down the growth of prostate cancer by blocking the action of the male hormone testosterone and other male hormones called androgens. Radiation therapy uses high energy alpha particles to kill tumor cells and shrink tumors. Enzalutamide with or without radium Ra 223 dichloride may work better in treating patients with castration-resistant prostate cancer.
    Location: 3 locations

  • Capivasertib with or without Enzalutamide or Fulvestrant in Treating Patients with Advanced, Metastatic, or Recurrent Solid Tumors with AKT1, AKT2, or AKT3 Mutations

    This pilot phase I trial studies how well capivasertib with or without enzalutamide or fulvestrant work in treating patients with solid tumors with AKT1, AKT2, or AKT3 mutations that have spread to other places in the body or have come back. Capivasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Prostate specific antigen or estrogen can cause the growth of tumor cells. Hormone therapy using enzalutamide or fulvestrant may fight prostate or breast cancer by blocking the use of prostate specific antigen or estrogen by the tumor cells. Capivasertib with or without enzalutamide or fulvestrant may work better in treating patients with solid tumor with AKT1, AKT2, or AKT3 mutations.
    Location: 3 locations

  • Fulvestrant with or without Enzalutamide in Treating Patients with Estrogen Receptor Positive and HER2 Negative Breast Cancer

    This randomized phase II trial studies how well fulvestrant with or without enzalutamide works in treating patients with estrogen receptor positive and HER2 negative breast cancer. Drugs used in chemotherapy, such as fulvestrant, 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. Androgen can cause the growth of breast cancer cells. Hormone therapy using enzalutamide may fight breast cancer by blocking the use of androgen by the tumor cells. Giving fulvestrant and enzalutamide may work better in treating patients with breast cancer.
    Location: 3 locations

  • Fulvestrant and Enzalutamide in Treating Patients with Estrogen Receptor Positive and HER2 Negative Metastatic Breast Cancer

    This phase II trial studies how well fulvestrant and enzalutamide work in treating patients with estrogen receptor positive and HER2 negative breast cancer that has spread to other places in the body. Drugs used in chemotherapy, such as fulvestrant, 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. Androgen can cause the growth of breast cancer cells. Hormone therapy using enzalutamide may fight breast cancer by blocking the use of androgen by the tumor cells. Giving fulvestrant and enzalutamide may work better in treating patients with estrogen receptor positive and HER2 negative breast cancer.
    Location: 3 locations

  • Enzalutamide and Cabazitaxel in Treating Patients with Metastatic, Castration-Resistant Prostate Cancer

    This phase I / II trial studies the side effects and best dose of cabazitaxel when given together with enzalutamide in treating patients with prostate cancer that has spread to other places in the body (metastatic) and has not responded to treatment with hormones or no longer responds to treatment with hormones (hormone-resistant). Drugs used in chemotherapy, such as cabazitaxel, 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. Androgen can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of androgen by the tumor cells. Giving cabazitaxel together with enzalutamide may work better in treating metastatic, hormone-resistant prostate cancer.
    Location: 3 locations

  • A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

    The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study) which has completed, at a minimum, the primary analysis or the study specified evaluation period.
    Location: 2 locations

  • Rapid Cycle Combination Therapy in Treating Patients with Metastatic Castrate-Resistant Prostate Cancer

    This phase II trial studies how well rapid cycle combination therapy works in treating patients with prostate cancer that has not responded to surgery or hormone therapy and has spread to other places in the body. Androgen can cause the growth of tumor cells. Antihormone therapy, such as abiraterone acetate and enzalutamide, may lessen the amount of androgen made by the body. Drugs used in the chemotherapy, such as radium Ra 223 dichloride, cabazitaxel, and carboplatin, 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. Switching between different combinations of androgen deprivation therapy and chemotherapy after a short time may prevent drug resistance and help achieve better long-term control of prostate cancer.
    Location: 2 locations

  • Testosterone Therapy Followed by Enzalutamide or Abiraterone Acetate in Treating Patients with Prostate Cancer That Is Progressing on Combined Androgen Therapies

    This phase II trial studies how well testosterone therapy followed by enzalutamide or abiraterone acetate works in treating patients with prostate cancer that has become worse or spread on combined androgen therapies. Androgens, such as testosterone, can cause the growth of prostate cancer cells. Androgen therapies, such as enzalutamide and abiraterone acetate, suppress or block the production or action of testosterone. Rapid treatment with testosterone may make the cancer cells become sensitive to retreatment with enzalutamide or abiraterone acetate. Giving testosterone prior to enzalutamide or abiraterone acetate may have an effect on the growth of prostate cancer in men who have not responded to long term therapy to lower testosterone in their blood (castrating therapy).
    Location: 2 locations

  • Atezolizumab with or without Enzalutamide in Treating Men with Localized Prostate Cancer before Radical Prostatectomy

    This phase II trial studies how well atezolizumab works alone or in combination with enzalutamide in treating men with localized prostate cancer before radical prostatectomy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, may lessen the amount of androgens made by the body. Giving atezolizumab in combination with enzalutamide may work better in treating prostate cancer.
    Location: 2 locations

  • Enzalutamide with Venetoclax in Treating Patients with Metastatic Castration Resistant Prostate Cancer

    This phase Ib / II trial studies the side effects and best dose of venetoclax when given together with enzalutamide and to see how well they work in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, may lessen the amount of androgens made by the body. Venetoclax may target a special group of prostate cancer cells that is known to lead to resistance to treatment. Giving enzalutamide and venetoclax may work better in treating patients with castration resistant prostate cancer.
    Location: Roswell Park Cancer Institute, Buffalo, New York


1 2 Next >