In short
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.
Key points
- Clinical trials investigating Abiraterone are focused mainly on advanced prostate cancer, especially metastatic castration-resistant and metastatic hormone-sensitive disease. The studies range from early Phase 1 and Phase 2 research to large Phase 3 trials and one Phase 4 study. Many trials compare Abiraterone-based treatment with other active treatments, while some test combinations with other cancer drugs. The main outcomes include radiographic progression-free survival, overall survival, PSA response, and quality of life. Several studies also look at safety, tolerability, and dose-limiting toxicities in specific patient groups.
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.
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.
Conditions and patient groups
Most trials focus on men with metastatic prostate cancer, which means the cancer has spread beyond the prostate.
Several studies specifically include metastatic castration-resistant prostate cancer (mCRPC), a form that keeps growing even when testosterone is very low.
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.
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.
Trial phases and study designs
The research program includes Phase 1, Phase 1/2, Phase 2, Phase 3, and Phase 4 studies.
Phase 1 and Phase 1/2 trials mainly look at safety, tolerability, dose-limiting toxicities, and the right dose for expansion.
Phase 2 and Phase 3 studies are larger and usually compare Abiraterone-based treatment with another treatment strategy, placebo, or standard of care.
One Phase 4 study is looking at Abiraterone in a later-stage setting with or without abemaciclib, and it measures radiographic progression-free survival.
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.
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.
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.
Notable trial comparisons
Several studies compare Abiraterone with other active treatments, such as enzalutamide, docetaxel, darolutamide, or newer investigational drugs.
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.
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.
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.
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.
Some studies also track whether patients need dose changes, interruptions, or stop treatment because of side effects or lack of benefit.