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Abiraterone

Clinical trials are studying Abiraterone in several types of prostate cancer, including metastatic castration-resistant, metastatic hormone-sensitive, and hormone-naïve disease. These studies look at how well it works, how safe it is in trial settings, and whether it helps with outcomes such as progression-free survival and overall survival in different patient groups.

Table of Contents

Trial overview

These studies investigate Abiraterone in advanced prostate cancer and related settings, often as part of a comparison with other treatments or in combination with other anti-cancer drugs.[1][2][3]

The trial list includes studies in metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, metastatic hormone-naïve prostate cancer, and prostate cancer with HRR gene mutations or PSMA-positive disease.[1][2][3]

Conditions and patient groups

Most trials focus on men with metastatic prostate cancer, which means the cancer has spread beyond the prostate.[1][2]

Several studies specifically include metastatic castration-resistant prostate cancer (mCRPC), a form that keeps growing even when testosterone is very low.[1][3][4]

Other studies include metastatic hormone-sensitive prostate cancer (mHSPC) and metastatic hormone-naïve prostate cancer (mHNPC), where hormone-based treatment is still expected to help.[2][5]

Some trials narrow the group further, such as patients without BRCA1/2 mutations or with unknown BRCA status, patients with HRR gene mutations, or patients with PSMA-positive disease.[3][6][7]

Trial phases and study designs

The research program includes Phase 1, Phase 1/2, Phase 2, Phase 3, and Phase 4 studies.[1][2][3]

Phase 1 and Phase 1/2 trials mainly look at safety, tolerability, dose-limiting toxicities, and the right dose for expansion.[7][8][9]

Phase 2 and Phase 3 studies are larger and usually compare Abiraterone-based treatment with another treatment strategy, placebo, or standard of care.[2][3][10]

One Phase 4 study is looking at Abiraterone in a later-stage setting with or without abemaciclib, and it measures radiographic progression-free survival.[11]

Main endpoints being measured

The most common endpoint is radiographic progression-free survival (rPFS), which means the time until scans show the cancer is growing, or the patient dies.[3][10][11]

Other important endpoints include overall survival, progression-free survival, and PSA response, which measures how much the prostate-specific antigen blood level drops during treatment.[2][5][7]

Some trials also measure quality of life, using the FACIT-F scale, and look at safety outcomes such as adverse events, serious adverse events, and dose-limiting toxicities.[1][7][8]

Notable trial comparisons

Several studies compare Abiraterone with other active treatments, such as enzalutamide, docetaxel, darolutamide, or newer investigational drugs.[3][4][5][6]

Some studies test Abiraterone in combination with another drug, such as niraparib, olaparib, JSB462, tulmimetostat, or abemaciclib, to see whether the combination improves cancer control.[4][10][11][12][13]

Other studies use Abiraterone as part of a treatment choice for patients who have already received hormone therapy or who have deep PSA responses after earlier treatment.[2][6]

What participants may expect in these studies

Participants may receive Abiraterone alone, Abiraterone with another study drug, or a comparison treatment chosen by the study design.[3][10][11]

Depending on the trial, researchers may collect PSA tests, imaging scans, blood tests, ECGs, and quality-of-life questionnaires to track how treatment is working and how safe it is.[1][7][8]

Some studies also track whether patients need dose changes, interruptions, or stop treatment because of side effects or lack of benefit.[7][8]

Trial ID Phase Condition studied Status Enrollment
2025-521051-23-00Phase 2Metastatic castration-resistant prostate cancerAuthorised60
NCT05974774Phase 3Metastatic hormone-naïve prostate cancerAuthorised1244
2024-518623-30-00Phase 3Metastatic castration-resistant prostate cancer without BRCA1/2 mutations or unknownAuthorised68
2023-503254-12-00Phase 3Metastatic prostate cancerAuthorised753
2024-520156-22-00Phase 2Metastatic hormone-sensitive prostate cancerAuthorised150
2024-516036-94-00Phase 1Metastatic castrate-resistant prostate cancerAuthorised361
NCT02861573Phase 1Metastatic castration-resistant prostate cancerAuthorised1205
NCT02960022Phase 2Prostate cancerAuthorised643
NCT03903835Phase 3Metastatic prostate cancerAuthorised2150
2024-517422-25-00Phase 3Metastatic castration-resistant prostate cancerAuthorised960
2023-504263-16-00Phase 3Extension study for patients with cancer from prior Roche studiesAuthorised277
2023-506365-64-00Phase 3HRR gene-mutated metastatic castration-sensitive prostate cancerAuthorised698
2023-507672-52-00Phase 1/2PSMA-positive mHSPC and mCRPCAuthorised41
NCT03732820Phase 3Metastatic castration-resistant prostate cancerAuthorised633
NCT04647526Phase 3Metastatic castration-resistant prostate cancerAuthorised455

FAQ

  • What kinds of prostate cancer are being studied with Abiraterone? The trials include metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, metastatic hormone-naïve prostate cancer, and prostate cancer with specific gene changes. Some studies also include broader prostate cancer groups.
  • Who can take part in Abiraterone trials? Eligibility depends on the study. Some trials enroll men with advanced prostate cancer who have already had prior treatment, while others focus on newly diagnosed metastatic disease or patients with certain biomarker findings.
  • What are the main goals of these trials? The main goals are to compare Abiraterone-based treatment with other treatment options, or with placebo in some studies. Researchers measure outcomes such as radiographic progression-free survival, overall survival, PSA response, and quality of life.
  • What phases are Abiraterone trials in? The trial data include Phase 1, Phase 1/2, Phase 2, Phase 3, and one Phase 4 study. This means the research ranges from early safety testing to larger studies that compare treatment results.
  • Is Abiraterone being tested alone or with other treatments? Both are being studied. Some trials test Abiraterone with other drugs such as niraparib, olaparib, darolutamide, JSB462, or tulmimetostat, while others compare Abiraterone against other active treatments.

Ongoing Clinical Trials on Abiraterone

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Glossary

  • Metastatic: Cancer that has spread from the prostate to other parts of the body.
  • Castration-resistant prostate cancer (CRPC): Prostate cancer that keeps growing even when testosterone is kept very low.
  • Hormone-sensitive prostate cancer (HSPC): Prostate cancer that still responds to hormone-based treatment.
  • Hormone-naïve: Cancer that has not yet been treated with hormone therapy.
  • Progression-free survival (PFS): The length of time during and after treatment that the cancer does not get worse.
  • Radiographic progression-free survival (rPFS): Time until the cancer gets worse on scans or imaging tests, or the patient dies.
  • Overall survival (OS): The length of time from the start of the study until death from any cause.
  • PSA: Prostate-specific antigen, a blood marker used to help track prostate cancer.
  • Biochemical response: A change in blood test results, often a drop in PSA, that suggests the treatment is working.
  • Quality of life (QoL): How a treatment affects daily life, symptoms, and well-being.
  • Adverse event (AE): Any unwanted medical problem that happens during a study.
  • Dose-limiting toxicity (DLT): A side effect that is serious enough to limit how much of a treatment can be given.

References

  1. https://clinicaltrials.gov/study/2025-521051-23-00
  2. https://clinicaltrials.gov/study/NCT05974774
  3. https://clinicaltrials.gov/study/2024-518623-30-00
  4. https://clinicaltrials.gov/study/2023-503254-12-00
  5. https://clinicaltrials.gov/study/2024-520156-22-00
  6. https://clinicaltrials.gov/study/NCT03903835
  7. https://clinicaltrials.gov/study/2023-507672-52-00
  8. https://clinicaltrials.gov/study/2024-516036-94-00
  9. https://clinicaltrials.gov/study/NCT02861573
  10. https://clinicaltrials.gov/study/NCT03732820
  11. https://clinicaltrials.gov/study/2023-506777-36-00
  12. https://clinicaltrials.gov/study/2025-521873-15-00
  13. https://clinicaltrials.gov/study/2025-521327-67-00