Table of contents

• Trial overview
• Patient groups studied
• Trial phases and designs
• Main endpoints measured
• Combination treatment studies
• Biomarker and gene-based trials
• What patients should know from these trials

Trial overview

The trial data show that Abiraterone Acetate is being studied mostly in prostate cancer, especially in advanced forms that have spread or are at high risk of spreading.^[1][2][3]

Many studies compare Abiraterone Acetate with other hormone treatments, placebo, or new drug combinations to see which approach gives better cancer control.^[4][5][6]

Patient groups studied

Several trials focus on men with metastatic hormone-sensitive prostate cancer, which means the cancer has spread but still responds to hormone treatment.^[1][7]

Other studies include men with metastatic castration-resistant prostate cancer, where the cancer keeps growing even after hormone lowering treatment.^[4][8][9]

Some trials are for more specific groups, such as patients with BRCA mutations, HRR gene mutations, PTEN deficiency, PSMA-positive disease, or oligometastatic or oligoprogressive disease.^{[2][3][10][11]}

Trial phases and designs

Most of the Abiraterone Acetate studies in the source data are Phase 3 trials, which usually test whether a treatment works better than a comparison treatment in larger groups of patients.^[1][4][5][6]

There is also a Phase 2 study that looks at Abiraterone Acetate in a smaller group and measures both safety and early effectiveness signals.^[12]

The studies use different designs, including randomized trials, open-label trials, and double-blind trials, which means patients may be assigned by chance and, in some studies, neither the patient nor the study team knows which treatment is given.^[4][5][13]

Main endpoints measured

The most common endpoint is radiographic progression-free survival (rPFS), which is the time before scans show the cancer has gotten worse or before death.^[1][4][7][8]

Other important endpoints include overall survival, metastasis-free survival, and PSA-related outcomes such as PSA decline or PSA levels at a set time point.^{[5][6][12][14]}

Some trials also measure safety outcomes, such as adverse events, serious adverse events, laboratory changes, and dose-limiting toxicities, which are side effects severe enough to limit the dose.^[12][15]

Combination treatment studies

Several trials test Abiraterone Acetate together with other medicines to see if the combination works better than standard treatment alone.^[4][5][6]

• Niraparib plus Abiraterone Acetate and prednisone is being studied in metastatic prostate cancer and in HRR gene-mutated metastatic castration-sensitive prostate cancer, with rPFS as the main outcome.^[5][6]

• Capivasertib plus Abiraterone Acetate is being tested in PTEN-deficient metastatic hormone-sensitive prostate cancer, with rPFS measured by the investigator.^[7]

• Saruparib plus standard hormone therapy is being studied in several prostate cancer trials, including patients receiving physician’s choice new hormonal agents that may include Abiraterone Acetate.^[3][13]

• Xaluritamig plus Abiraterone is being compared with investigator’s choice treatments in chemotherapy-naïve metastatic castration-resistant prostate cancer, with overall survival as the key endpoint.^[8]

Biomarker and gene-based trials

Some studies use biomarkers, which are body signals such as gene changes or blood test results, to choose who may benefit most from treatment.^[2][3]

For example, one trial studies men with a BRCA mutation, another focuses on HRR gene mutations, and another focuses on PTEN deficiency, showing that Abiraterone Acetate is being tested in more personalized treatment plans.^[2][6][7]

One large biomarker-driven study also includes Abiraterone Acetate among several treatment options and looks at whether treatment choice based on biomarker signals or ctDNA detectability can improve progression-free survival.^[13]

What patients should know from these trials

From the source data, Abiraterone Acetate is mainly being tested in men with advanced prostate cancer, not in early-stage disease.^[1][4][8]

The trials are designed to answer questions about how well treatment works, how long it can delay cancer growth, and how safe it is when used alone or with other drugs.^[5][12][15]

Because the studies are different in phase, patient group, and treatment plan, the results may not apply to every person with prostate cancer.^[1][7][13]