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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  • 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

  • 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

  • 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: 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 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 vibostolimab (+) pembrolizumab coformulation (MK-7684A), Cohort H will receive vibostolimab (+) pembrolizumab coformulation, 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: 6 locations

  • PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

    The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC)
    Location: 4 locations

  • Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency

    This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone / prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone / prednisolone) plus ADT in participants with mHSPC whose tumours are characterised by PTEN deficiency. The intention of the study is to demonstrate that in participants with mHSPC, the combination of capivasertib plus abiraterone (+prednisone / prednisolone) plus ADT is superior to placebo plus abiraterone (+prednisone / prednisolone) plus ADT in participants with mHSPC characterised by PTEN deficiency with respect to radiographic progression-free survival (rPFS) per 1) Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue and / or Prostate Cancer Working Group (PCWG3) for bone as assessed by the investigator 2) death due to any cause.
    Location: 5 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: 5 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

  • A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

    The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).
    Location: 5 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 With Enzalutamide or Abiraterone / Prednisone in Subjects With Castration Resistant Prostate Cancer Who Have Not Received Chemotherapy

    A Phase 1b / 2 Study to Examine Tazemetostat in Combination with Enzalutamide or Abiraterone / Prednisone in Patients with Metastatic Castration Resistant Prostate Cancer and Have Not Received Chemotherapy
    Location: 2 locations

  • Evaluation of Response to Abiraterone Acetate, Prednisone, and Androgen Deprivation Therapy by Race or Ethnicity in Patients with Metastatic Prostate Cancer

    This phase II trial is to find out whether men from different races and ethnic groups with prostate cancer that has spread to other places in the body (metastatic) respond differently to the combination of androgen deprivation therapy (either a shot or surgery to remove the testicles) plus the drug abiraterone acetate and prednisone. 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. Information gained form this study may help the researchers better understand whether certain factors, such as race or ethnicity play a role in how a patient responds to cancer treatment. This may help identify better and more personalized treatments in the future.
    Location: 3 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

  • Androgen Deprivation Therapy, Pembrolizumab, and Stereotactic Body Radiation Therapy with or without TLR9 Agonist SD-101 in Treating Patients with Metastatic Prostate Cancer

    This randomized phase II trial studies how well androgen deprivation therapy, pembrolizumab, and stereotactic body radiation therapy with or without TLR9 agonist SD-101 in treating patients with prostate cancer that has spread to other places in the body. Androgen can cause the growth of tumor cells. Androgen deprivation therapy, such as leuprolide acetate, prednisone, and abiraterone acetate may lessen the amount of androgen made by the body. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. 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. SD-101 may stimulate the body’s immune response by increasing the ability of immune cells to recognize and kill tumor cells. It is not yet known whether giving androgen deprivation therapy, pembrolizumab, and stereotactic body radiation therapy with or without TLR9 agonist SD-101 may work better in treating patients with prostate cancer.
    Location: 2 locations


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