Table of Contents
- Trial overview
- Conditions and patient groups
- Trial phases and study designs
- Main endpoints being measured
- Notable trial comparisons
- What participants may expect in these studies
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]
