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 26-48 of 48

  • Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

    This phase Ib trial determines if samples from a patient’s cancer can be tested to find combinations of drugs that provide clinical benefit for the kind of cancer the patient has. This study is also being done to understand why cancer drugs can stop working and how different cancers in different people respond to different types of therapy.
    Location: OHSU Knight Cancer Institute, Portland, Oregon

  • 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

  • Transdermal Testosterone and Enzalutamide in Treating Patents with Castration Resistant Prostate Cancer Receiving Androgen Deprivation Therapy

    This early phase I trial studies how well testosterone works when delivered through the skin and is used alternately with enzalutamide in treating patients with castration-resistant prostate cancer who are receiving androgen deprivation therapy. Hormone therapy using testosterone may help to maintain the amount of testosterone in the body, and enzalutamide may help to reduce the prostate specific antigen level. Giving transdermal testosterone alternately with enzalutamide may work better in treating patients with castration resistant prostate cancer.
    Location: University of Colorado Hospital, Aurora, Colorado

  • Enzalutamide and Relacorilant in Treating Patients with Metastatic Castration Resistant Prostate Cancer

    This phase I trial studies the best dose and side effects of enzalutamide and relacorilant in treating patients with castration resistant prostate cancer that has spread to other places in the body. Drugs, such as enzalutamide and relacorilant, may lessen the amount of androgens made by the body. It is not yet known whether enzalutamide and relacorilant may work better in treating patients with castration resistant prostate cancer.
    Location: University of Chicago Comprehensive Cancer Center, Chicago, Illinois

  • Combining CRLX101, a Nanoparticle Camptothecin, With Enzalutamide in People With Progressive Metastatic Castration Resistant Prostate Cancer Following Prior Enzalutamide Treatment

    Background: Some prostate cancer keeps growing even when testosterone in the body drops to very low levels. This is called castrate-resistant prostate cancer. One treatment is enzalutamide. This is a modern hormonal therapy. But it only works for a certain amount of time and then the cancer becomes resistant to it. Researchers want to see if adding the treatment CRLX101 could make enzalutamide work again for people who have already had it. Objective: To test a new way of treating prostate cancer using CRLX101 plus enzalutamide in people with certain prostate cancer who already had enzalutamide treatment. Eligibility: Adults ages 18 years and older with metastatic, castration-resistant prostate cancer who have had enzalutamide treatment Design: Participants will be screened with a medical history and physical exam. They will have blood and urine tests. They will have a scan of the chest / abdomen / pelvis. They will have a bone scan. Participants will get treatment in cycles. A cycle lasts 28 days. They will take enzalutamide by mouth once a day. They will get CRLX101 through an IV every 1 or 2 weeks. Participants will repeat screening tests throughout the study. Participants will have a follow-up visit 3 4 weeks after they stop taking the study drug. They will repeat most screening tests and have an electrocardiogram.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • GnRH analog, Abiraterone Acetate, and Prednisone in Treating Patients with Stage IV Castration Sensitive Prostate Cancer

    This phase Ib trial studies how GnRH analog, abiraterone acetate, and prednisone work in treating patients with stage IV castration sensitive prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as GnRH analog, abiraterone acetate, and prednisone may lessen the amount of androgen made by the body.
    Location: Moffitt Cancer Center, Tampa, Florida

  • IONIS-AR-2.5Rx and Enzalutamide in Treating Patients with Metastatic Castration-Resistant Prostate Cancer

    This phase Ib / II trial studies the side effects and best dose of IONIS-AR-2.5Rx 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. Drugs used in chemotherapy, such as IONIS-AR-2.5Rx and enzalutamide, 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.
    Location: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan

  • Alpelisib and Enzalutamide in Treating Patients with Androgen Receptor and PTEN Positive Metastatic Breast Cancer

    This phase I trial studies the side effects and best dose of alpelisib when given together with enzalutamide in treating patients with androgen receptor and PTEN positive breast cancer that has spread to other places in the body. Alpelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Androgen receptor can cause the growth of breast cancer cells. Hormone therapy using enzalutamide may fight breast cancer by lowering the amount of androgen the body makes. Giving alpelisib and enzalutamide may work better in treating patients with breast cancer.
    Location: M D Anderson Cancer Center, Houston, Texas

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

    This phase I trial studies the side effects and best dose of cabazitaxel when given together with prednisone, abiraterone, and enzalutamide in treating patients with castration-resistant prostate cancer that has spread to other places in the body. Prednisone is an orally given steroid drug that helps in blocking some side effects of abiraterone. Abiraterone may lower the level of testosterone and enzalutamide may block the action of testosterone and these actions will prevent the growth of prostate cancer. 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. Giving prednisone, abiraterone, cabazitaxel, and enzalutamide may work better in treating patients with castration-resistant cancer.
    Location: University of Alabama at Birmingham Cancer Center, Birmingham, Alabama

  • Enzalutamide and Indomethacin in Treating Patients with Recurrent or Metastatic Castration-Resistant Prostate Cancer

    This phase I / II trial studies the side effects of enzalutamide and indomethacin and to see how well they work in treating patients with prostate cancer that does not respond to treatment with hormones despite surgical removal of testes (castration-resistant), has come back (recurrent), or has spread from where it started to other places in the body (metastatic). Androgens can cause the growth of prostate cancer cells. Indomethacin is a non-steroidal anti- inflammatory drug that has been found to block one of the signals that enhance prostate cancer cell growth. Hormone therapy using enzalutamide and indomethacin may fight prostate cancer by lowering the amount of androgen the body makes and / or blocking the use of androgen by the tumor cells.
    Location: University of California Davis Comprehensive Cancer Center, Sacramento, California

  • Enzalutamide and Paclitaxel before Surgery in Treating Patients with Stage I-III Androgen Receptor-Positive Triple-Negative Breast Cancer

    This phase IIB trial studies how well enzalutamide and paclitaxel before surgery works in treating patients with stage I-III androgen receptor-positive triple-negative breast cancer. Androgens can cause the growth of triple-negative breast cancer. Anti-hormone therapy, such as enzalutamide, prevent androgen from binding to the androgen receptor, thereby decreasing cell growth and causing tumor cell death. Drugs used in chemotherapy, such as 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 and paclitaxel before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. This treatment study is part of the MD Anderson Moonshot initiative.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer

    This is a Phase 1b / 2, open-label, multicenter platform trial to evaluate the antitumor activity and safety of AB928-based combination therapy in participants with metastatic castrate resistant prostate cancer (mCRPC).
    Location: 2 locations

  • A Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of Capivasertib (AZD5363) in Combination With Novel Agents in Patients With Metastatic Prostate Cancer

    This is a Phase Ib, open-label, multi-centre study to determine the safety, tolerability and pharmacokinetics (PK) of capivasertib when given in combination with novel agents (enzalutamide or abiraterone) to inform the selection of capivasertib dose regimens for each combination for further clinical evaluation when given to patients with metastatic castration resistant prostate cancer (CRPC). The study design allows an exploration of different doses with intensive safety monitoring to ensure the safety of the patients.
    Location: Indiana University / Melvin and Bren Simon Cancer Center, Indianapolis, Indiana

  • Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol

    Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol
    Location: UCSF Medical Center-Mount Zion, San Francisco, California

  • HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

    This study is a multinational Phase 3, randomized, double-blind, non-inferiority, efficacy and safety study of oral HC-1119 (80 mg / day) versus enzalutamide (160 mg / day) in asymptomatic or mildly symptomatic patients with progressive metastatic castration-resistant prostate cancer (mCRPC). The following assessment of prostate cancer status will be collected during the course of the trial: soft tissue disease on computed tomography (CT) scan or on magnetic resonance imaging (MRI), bone disease on radionuclide bone scans, FACT-P and EQ-5D, Brief Fatigue Inventory, and PSA. Throughout the study, safety and tolerability will be assessed by the recording of adverse events, monitoring of vital signs and physical examinations, safety laboratory evaluations, and 12-lead electrocardiograms (ECGs). Blood samples for population pharmacokinetics for HC-1119 and enzalutamide and related metabolites will be collected.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • ZEN-3694, Enzalutamide, and Pembrolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer

    This phase II trial investigates how well ZEN-3694, enzalutamide, and pembrolizumab work in treating patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). ZEN-3694 blocks the expression of the MYC gene to prevent cellular growth in certain types of tumors, including castrate resistant prostate cancer. Enzalutamide has been shown to block testosterone from reaching prostate cancer cells by binding to a receptor on prostate cancer cells, called androgen receptors. This works similar to a lock and key. When enzalutamide (key) inserts into the androgen receptor (lock) testosterone cannot attach to the androgen receptor, which slows the growth of tumor cells and may cause them to shrink. Pembrolizumab is a monoclonal antibody (proteins that can protect the body from foreign organisms, such as bacteria and viruses) designed to block a specific control switch which may be activated by tumor cells to overcome the body’s natural immune system defenses. It also enhances the activity of the body’s immune cells against tumor cells. The purpose of this study is to find out the effects ZEN-3694, enzalutamide, and pembrolizumab on patients with metastatic castration-resistant prostate cancer who have previously experienced disease progression.
    Location: UCSF Medical Center-Mount Zion, San Francisco, California

  • Enzalutamide and Decitabine in Treating Patients with Metastatic Castration Resistant Prostate Cancer

    This phase I / II trial studies the side effects and best dose of decitabine and how well it works when given together with enzalutamide in treating patients with castration resistant prostate cancer that has spread to other places in the body. Androgen can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, may lessen the amount of androgen made by the body. Decitabine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving decitabine and enzalutamide may work better in treating participants with castration resistant prostate cancer.
    Location: Roswell Park Cancer Institute, Buffalo, New York

  • CASPAR, A Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men with Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy

    This phase III trial compares the addition of rucaparib to enzalutamide with enzalutamide alone for the treatment of men with prostate cancer that has spread to other places in the body (metastatic) and has become resistant to androgen-deprivation therapy. 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 role in prostate cancer development. Enzalutamide may help fight prostate cancer by blocking the use of testosterone by the tumor cells for growth. PARPs are proteins that help repair deoxyribonucleic acid (DNA) mutations. PARP inhibitors, such as rucaparib, can keep PARPs from working , so tumor cells can't repair themselves. This may stop tumor cells from growing. Giving enzalutamide and rucaparib may prolong patients’ survival and / or prevent their cancer from growing or spreading for a longer time. It may also help doctors learn if a mutation in any of the specific DNA repair (homologous recombination) genes is helpful in selecting the most appropriate treatment for the patient.
    Location: Location information is not yet available.

  • 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

  • Cognitive Assessment and MRI Program in Identifying Cognitive Effects of Androgen Receptor Directed Therapies in Patients with Advanced Prostate Cancer

    This clinical trial studies how well cognitive assessment and magnetic resonance imaging (MRI) program work in identifying cognitive effects of androgen receptor directed therapies such as abiraterone acetate and enzalutamide in patients with prostate cancer that has spread from where it started to other places in the body. Cognitive assessment and MRI program may help to assess the cognitive function of patients during treatment and identify genetic variations that might make patients more or less sensitive to cognitive changes during treatment for prostate cancer.
    Location: 5 locations

  • Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET / CT in Newly Diagnosed Prostate Cancer

    Background: Prostate cancer is a common cancer among men. There are several ways to treat it, including hormone blocking drugs, radiation therapy, and surgery. Researchers want to combine abiraterone and enzalutamide to see if there is a better way to treat prostate cancer. They also want to study a new radiotracer called 18F-DCFPyL, with the help of a scan called positron emission tomography / computed tomography (PET / CT) to see if there is a better way to detect prostate cancer. Objective: To develop improved techniques to localize and detect prostate cancer; and to develop new ways to treat prostate cancer Eligibility: Men ages 18 and older with prostate cancer that has not spread to other parts of the body Design: - Participants will have a medical evaluation to determine eligibility for the study. - Participants will take three different medications daily by mouth and receive two injections during the course of the study. - Participants will have a medical evaluation monthly (for 6 months) while taking the medications. - Participants will have prostate MRI and PET / CT scans before treatment, 2 months after starting treatment and again before surgery. The radiotracer will be given by injection about 2 hours before the whole-body scan. The PET / CT scan itself is about an hour. - Participants may be asked to do a biopsy before treatment and 2 months after starting treatment. - Participants will have a full medical evaluation before surgery to remove their prostate. - Participants will have a follow-up visit 3 months after surgery and then as needed. - Participants will be contacted once a year for their PSA and testosterone levels for 5 years...
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Study to Compare Capsule and Liquid Formulations of Enzalutamide After Single Dose Administration Under Fasting Conditions in Prostate Cancer

    Background: Enzalutamide is given to treat metastatic prostate cancer. But it takes 4 pills to deliver the effective dose. This can be difficult for people already taking multiple drugs. And swallowing may be difficult for some people. Researchers want to test out a new way of giving enzalutamide by mouth. They want to see if giving a person the liquid taken from inside the standard 4 gelatin capsules is handled by the body in the same way as giving them the capsules whole. Objectives: To compare how capsule and liquid forms of enzalutamide are handled by people with prostate cancer. Eligibility: Men at least 18 years old with prostate cancer Design: Participants will be screened with a heart test (electrocardiogram), medical history, and physical exam. A tissue sample or lab reports will be reviewed. During the study, participants will repeat screening tests and have urine tests. Participants will be randomly assigned to get the study drug in one of two orders: either the as capsules then the liquid form (Arm A) or as the liquid form then the capsule form (Arm B). Participants will be counseled about birth control. The study will have 2 periods with a minimum 42 day break in between. On Day 1 of Period 1 and Day 1 of Period 2, participants will be admitted to the hospital. They will get one dose of the study drug. They cannot eat or drink anything except water for at least 10 hours before and for 4 hours after the study drug. Their blood will be sampled over 24 hours. Lunch and dinner will be served. Participants will answer questions after taking the liquid form. Participants will have blood drawn on Day 3, Day 8, and Day 42.
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide

    This is a prospective, randomized, open-label phase II study comparing cognitive outcomes between men with non-metastatic and metastatic castration-resistant prostate cancer (mCRPC or M0CRPC) treated with darolutamide or enzalutamide. Approximately 132 patients will be enrolled. Eligible patients will be randomized in a 1:1 fashion to treatment with enzalutamide 160 mg orally daily or darolutamide 600 mg orally twice daily, in combination with standard LHRH agonist based treatment. Cognitive assessments will be performed using modules from Cambridge Neuropsychological Test Automated Battery (CANTAB) an internationally recognized software for assessing cognitive function and impairment.
    Location: Medical University of South Carolina, Charleston, South Carolina