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 48
1 2 Next >

  • 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: 12 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: 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

  • 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: 9 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: 7 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 (recurrent). 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 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: 7 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. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of the patients. Expansion cohorts will further assess safety and preliminary anti-tumor activity in a variety of advanced solid tumor malignancies. Other dosing schedules and / or combinations may be evaluated based on the emerging PK and safety data. 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: 5 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: 5 locations

  • Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991 / KEYNOTE-991)

    This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus ADT versus placebo plus enzalutamide plus ADT in participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS).
    Location: 5 locations

  • Study to Evaluate CORT125281 in Combination With Enzalutamide in Patients With mCRPC

    This is an open-label, Phase 1 / 2a dose escalation study with an expansion phase to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD), and preliminary efficacy of CORT125281 in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) to identify a recommended dose (RD) for Phase 2 studies.
    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

  • Implantable Microdevice for the Evaluation of Drug Response in Patients with Prostate Cancer

    This phase I trial investigates the feasibility and safety of an implantable microdevice for the evaluation of drug response in patients with prostate cancer. Implanting and retrieving a microdevice that releases up to 20 drugs directly within the prostate cancer lesion may help to evaluate the effectiveness of several approved cancer drugs against prostate cancer. Once optimized, the implantable microdevice may be able to predict the efficacy of specific drugs for each patient’s tumor and inform therapeutic decision-making.
    Location: 2 locations

  • Study of ORIC-101 in Combination With Enzalutamide

    The purpose of this study is to establish the recommended phase 2 dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ORIC-101 in combination with enzalutamide (Xtandi®) when administered to patients with metastatic prostate cancer progressing on enzalutamide.
    Location: 2 locations

  • PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors

    A Phase 1 dose escalation study evaluating safety, tolerability and pharmacokinetics of PF-06952229 in adult patients with advanced solid tumors.
    Location: 3 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: 2 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

  • Opaganib and Androgen Antagonists for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer

    This phase II trial studies how well opaganib works when added to androgen antagonists in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Opaganib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Testosterone can cause the growth of prostate cancer cells. Androgen antagonists, such as abiraterone and enzalutamide, may help fight prostate cancer by lowering the amount of testosterone made by the body, or by blocking the use of testosterone by the tumor cells. Giving opaganib with androgen antagonists may work better than androgen antagonists alone in treating patients with castration resistant prostate cancer.
    Location: Medical University of South Carolina, Charleston, South Carolina

  • Study of Tazemetostat Together With Enzalutamide or With Abiraterone / Prednisone in Subjects With Castration Resistant Prostate Cancer That Has Spread Who Have Not Yet Received Chemotherapy

    This is a global, multi-center, open-label, randomized phase 1b, active-controlled safety and efficacy study of oral administration of tazemetostat in combination with enzalutamide or abiraterone / prednisone (phase 1b) versus enzalutamide or abiraterone / prednisone alone in asymptomatic or mildly symptomatic subjects with progressive, metastatic castration-resistant prostate cancer (mCRPC) who have progressed on either abiraterone acetate, enzalutamide, or apalutamide or who are second generation anti-androgen treatment naive, and who have not received chemotherapy for mCRPC. This study is designed to determine the recommended phase 2 doses (RP2D) of tazemetostat in combination with either enzalutamide or abiraterone / prednisone, based on safety, tolerability, pharmacokinetic, pharmacodynamic, and efficacy profiles.
    Location: University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania

  • Study of Oral Rucaparib With Other Anticancer Agents in Metastatic Castration Resistant Prostate Cancer Patients (RAMP)

    Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral Rucaparib in Combination with Other Anticancer Agents in Patients with Metastatic Castration Resistant Prostate Cancer
    Location: University of Minnesota / Masonic Cancer Center, Minneapolis, Minnesota

  • Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC)

    Researchers in this study want to compare the effects of drug darolutamide and drug enzalutamide on physical function, including balance and daily activity, in patients with castration-resistant prostate cancer (CRPC). Both darolutamide and enzalutamide are approved AR inhibitors used for the treatment of patients with CRPC. AR inhibitor is a substance that keeps androgens (male sex hormones) from binding to proteins called androgen receptors, which are found in normal prostate cells, some prostate cancer cells, and in some other cells. Preventing this binding blocks the effects of these hormones in the body and therefore keeps prostate cancer cells from growing. Patients participating this study will receive either darolutamide or enzalutamide tablets. To evaluate the physical function, patients will be asked to make some movements like rising from a chair, walking three meters, etc. Additionally, researchers also want to find out the survival of patients and if patients have fatigue (feeling tired), cognitive (learning and thinking) problems, or other medical problems during the trial. Brand name of darolutamide is Nubeqa; brand name of enzalutamide is Xtandi.
    Location: 3 locations


1 2 Next >