Clinical Trials Using Abiraterone Acetate

Clinical trials are research studies that involve people. The clinical trials on this list are studying Abiraterone Acetate. 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 40
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  • Abiraterone Acetate and Antiandrogen Therapy with or without Cabazitaxel and Prednisone in Treating Patients with Metastatic, Castration-Resistant Prostate Cancer Previously Treated with Docetaxel

    This randomized phase II trial studies how well abiraterone acetate and antiandrogen therapy, with or without cabazitaxel and prednisone, work in treating patients with castration-resistant prostate cancer previously treated with docetaxel that has spread to other parts of the body. Androgens can cause the growth of prostate cancer cells. Hormone therapy using abiraterone acetate and antiandrogen therapy may fight prostate cancer by lowering and / or blocking the use of androgens by the tumor cells. Drugs used in chemotherapy, such as cabazitaxel and prednisone, 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 abiraterone acetate and antiandrogen therapy with or without cabazitaxel and prednisone may help kill more tumor cells.
    Location: 642 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: 101 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

  • 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

  • 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 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

  • 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: 11 locations

  • Apalutamide, Abiraterone Acetate, Prednisone, and Radiation Therapy in Treating Patients with Prostate Cancer

    This phase II trial studies how well apalutamide, abiraterone acetate, prednisone, and radiation therapy work in treating patients with prostate cancer. Testosterone can cause the growth of prostate cancer cells. Apalutamide blocks the use of testosterone by the tumor cells. Abiraterone acetate lowers the amount of testosterone made by the body. This may help stop the growth of tumor cells that need testosterone to grow. Anti-inflammatory drugs, such as prednisone lower the body’s immune response and are used with other drugs in the treatment of some types of cancer. 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. It is not known which combination will work best in treating prostate cancer.
    Location: 9 locations

  • A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer

    This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer. Prednisolone may be used instead of prednisone per local regulation.
    Location: 11 locations

  • Study of Abiraterone, Atezolizumab, Lupron, and Radiation Therapy for the Treatment of Men with Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer, SAABR Study

    This phase II trial studies how well abiraterone acetate, atezolizumab, lupron, and stereotactic body radiotherapy works for the treatment of men with hormone-sensitive prostate cancer that has spread to different parts of the body (metastatic). Abiraterone acetate works by decreasing the production of the male sex hormone (testosterone) that causes prostate cancer to grow. The steroid drug prednisone is given with abiraterone acetate to reduce or prevent some of its side effects. Lupron (leuprolide) is a hormone treatment that reduces levels of testosterone, which slows the growth of prostate cancer. Atezolizumab is a type of drug called a PD-L1 blocker; it blocks a protein located on the surface of some tumor cells and immune cells that can act as a “brake” on the immune system. Blocking this protein releases the brakes, allowing the immune system to function more efficiently to identify and attack cancer cells. Stereotactic body radiotherapy delivers very precisely targeted high-dose radiation in less time than standard radiation therapy, which reduces potential damage to healthy tissues near the targeted treatment area. Adding atezolizumab and stereotactic body radiotherapy to treatment with abiraterone acetate, prednisone, and lupron may boost the immune system's ability to identify and destroy cancer cells, which may prevent the cancer from getting worse.
    Location: 7 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 nine cohorts in this study: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, Cohort C will receive pembrolizumab + enzalutamide, Cohort D will receive pembrolizumab + abiraterone + prednisone Cohort E will receive pembrolizumab+lenvatinib, Cohort F will receive pembrolizumab+lenvatinib, Cohort G will receive MK-7684A, Cohort H will receive MK-7684A, and Cohort I will receive pembrolizumab+carboplatin+etoposide in Arm 1 and carboplatin+etoposide in Arm 2. Outcome measures will be assessed individually for each cohort.
    Location: 7 locations

  • A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

    The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP plus placebo.
    Location: 7 locations

  • Carboplatin, Cabazitaxel and Abiraterone in Treating Patients with Metastatic Castration Sensitive Prostate Cancer

    This phase II trial studies how well carboplatin, cabazitaxel and abiraterone work in treating patients with prostate cancer that has spread to other areas of the body (metastatic), but is still responding to hormone therapy (castration sensitive). Drugs used in chemotherapy, such as carboplatin and 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. Abiraterone may block tissues from making androgens (male hormones), which may cause the death of tumor cells that need androgens to grow. Giving carboplatin, cabazitaxel and abiraterone may improve cancer control.
    Location: 5 locations

  • A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

    The purpose of this study is to: a) establish the recommended phase 2 dose (RP2D) and to evaluate the antitumor activity and safety of niraparib combination therapies (Combinations 1 and 2) and b) to determine the relative bioavailability of niraparib and abiraterone acetate (AA) in combination (Combination 3) in participants with metastatic castration-resistant prostate cancer (mCRPC).
    Location: 7 locations

  • PK and Dose Escalation and Expansion Study of DST-2970

    This is a Phase I multi-center, open-label, study of DST-2970 to determine the MTD, overall safety / tolerability, PK / pharmacodynamic parameters, and efficacy in prostate cancer patients.The study will include a dose escalation phase followed by a dose expansion phase. Each cohort will consist of a "run-in" period to assess pharmacokinetic trough, as well as C1hour, C2hour, and C3hour levels of standard of care abiraterone acetate, followed by a minimum of an 80-hour washout (treatment delay), then initiation of treatment with DST-2970. The patient population that will be evaluated in this study include patients with castration sensitive or castration resistant prostate cancer who experience a rising PSA, with or without radiographic progression, while taking abiraterone acetate. In this protocol, "initial PSA response to abiraterone" is defined as having a ≥ 30% drop in PSA levels (confirmed by a second PSA level one month later) during the first 6 months of treatment with abiraterone. These patients who subsequently experience a rise in PSA while on abiraterone are considered as having "acquired resistance" to abiraterone in the context of this protocol. Patients not meeting the definition of having an "initial PSA response to abiraterone" are considered as having "primary resistance" to abiraterone in the context of the protocol. In the dose escalation phase, all patients with a rising PSA can be enrolled, whether they had an "initial PSA response to abiraterone" or never responded to abiraterone. Two expansion cohorts will be opened. One expansion cohort will evaluate patients who did achieve an "initial PSA response to abiraterone" within the first 6 months of treatment as defined above, but subsequently progressed by PSA with or without radiographic progression. A second expansion cohort will evaluate patients who did not achieve an "initial PSA response to abiraterone" as defined above but have PSA progression with or without radiographic progression. The rationale of the study is to determine if the better bioavailability of DST-2970 will overcome resistance to abiraterone acetate experienced in these two clinical settings. In all cohorts, treatment will continue until progressive disease, unacceptable toxicity, investigator and / or sponsor decision, intercurrent illness or patient withdrawal of consent. Patients will be monitored regularly with physical examination and laboratory tests.
    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

  • 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: 2 locations

  • 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: 2 locations

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

    This phase II trial studies how well abiraterone acetate, prednisone, and apalutamide work in treating patients with hormone-naive prostate cancer that has spread to other places in the body. Androgen can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate and apalutamide may lessen the amount of androgen made by the body.
    Location: 2 locations

  • Conventional Androgen Deprivation Therapy with or without Abiraterone, Prednisone, and Apalutamide for the Treatment of High Risk Prostate Cancer after Radiation and Male Hormone Deprivation Therapy

    This phase III trial studies conventional male hormone (androgen) deprivation therapy (also called hormonal therapy), abiraterone acetate (abiraterone), prednisone, and apalutamide to see how well this combination works compared with conventional androgen deprivation therapy alone in treating patients with prostate cancer who have already received radiation therapy and who are receiving long-term hormonal therapy for their prostate cancer and whose prostate specific antigen (PSA) remains detectable despite having received at least 6 months of hormonal therapy. Androgen deprivation therapy blocks the function of male hormones, including testosterone which prostate cancer cells use to grow and spread. Adding abiraterone, prednisone, and apalutamide to the conventional androgen deprivation therapy may work better than conventional androgen deprivation therapy alone in treating patients with detectable PSA who have received radiation therapy and are being treated with long-term hormonal therapy for their prostate cancer.
    Location: 5 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

  • Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC

    This is a Phase 3, multi-center, randomized, open-label, controlled study designed to evaluate the safety and efficacy of cabozantinib given in combination with atezolizumab versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with one, and only one, NHT for their prostate cancer disease.
    Location: Fox Chase Cancer Center, Philadelphia, Pennsylvania

  • Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer

    This phase II trial studies how well the combination of apalutamide, abiraterone acetate, and prednisone after chemotherapy work in treating patients that have received no prior treatment (treatment naive) for high risk prostate cancer that is sensitive to androgen deprivation therapy (castration sensitive) and has spread to other parts of the body (metastatic). This study also aims to understand the inheritance of prostate cancer. If a gene or genes that cause prostate cancer can be found, the diagnosis and treatment of prostate cancer may be improved. Testosterone (a male hormone) can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Antihormone therapy, such as abiraterone acetate, may lessen the amount of testosterone made by the body. Anti-inflammatory drugs such as prednisone lower the body’s immune response and are used with other drugs in the treatment of some types of cancer. Apalutamide, abiraterone acetate, and prednisone after chemotherapy may work better in treating patients with castration sensitive prostate cancer.
    Location: OHSU Knight Cancer Institute, Portland, Oregon


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