In short
Clinical trials investigating ABIRATERONE DECANOATE are studying related treatment strategies in prostate cancer, mainly to assess safety and efficacy. The available trial data focus on men with metastatic castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer, including people who have not used androgen receptor pathway inhibitors before.
Key points
- Clinical trial data for ABIRATERONE DECANOATE focus on prostate cancer, especially metastatic castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer. The available study is a Phase 2 interventional trial with 218 planned participants. It looks at both efficacy and safety, including PSA response, toxicity, lab tests, ECGs, vital signs, and physical exam findings. Some groups are ARPI-naïve, meaning they have not used an androgen receptor pathway inhibitor before. The trial also includes different treatment setups, including steroid use in some cohorts and a Japanese safety cohort.
Trial overview
The available clinical trial for ABIRATERONE DECANOATE is a Phase 2 interventional study in prostate cancer. It is designed to learn more about how well the study treatment works and how safe it is in different groups of participants.
The trial includes people with metastatic castration-resistant prostate cancer (mCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC). These are two advanced forms of prostate cancer, and the study looks at them in separate cohorts, or participant groups.
Who can participate
The study includes ARPI-naïve participants, which means people who have not used an androgen receptor pathway inhibitor before. One part of the study focuses on ARPI-naïve mCRPC participants, while another focuses on ARPI-naïve mHSPC participants.
The trial also includes a safety run-in for mHSPC participants and a safety cohort for Japanese participants with mCRPC or mHSPC. A safety run-in is an early part of a study used to check safety before moving to the main evaluation.
What is being measured
The main outcome in one cohort is the proportion of participants with a PSA decline of 90% or more from baseline. Baseline means the starting point before treatment begins.
In the mHSPC cohort, the study measures the proportion of participants with PSA at 0.2 ng/mL or lower at 8 months. PSA is a blood marker used to follow prostate cancer activity.
Safety outcomes include dose-limiting toxicities, adverse events, serious adverse events, laboratory results, electrocardiograms, vital signs, physical examinations, and ECOG performance status scores. Adverse events are unwanted medical problems that happen during a study, and serious adverse events are the more severe ones.
The study also tracks mineralocorticoid toxicity, defined in the trial as having neither Grade 1 or higher low potassium nor Grade 2 or higher high blood pressure. This helps researchers see whether the treatment can be given without certain hormone-related problems.
Trial design and treatment groups
The trial compares ASP5541-based treatment with abiraterone acetate-based treatment in some cohorts. In Cohort 1, the study evaluates efficacy in ARPI-naïve mCRPC participants using ASP5541 with prednisone or prednisolone versus abiraterone acetate with prednisone or prednisolone.
In Cohort 2, the study first includes a safety run-in without steroids in mHSPC participants, then evaluates efficacy of ASP5541 without steroids compared with abiraterone acetate with prednisone or prednisolone in ARPI-naïve mHSPC participants. In Cohort 3, the study looks at safety in Japanese mCRPC or mHSPC participants using ASP5541 with prednisone or prednisolone.
The brief summary shows that the study is organized into several cohorts so researchers can answer different questions about benefit and safety in different prostate cancer settings.
Phase and study status
This is a Phase 2 study, which means it is past the first early safety step and is now looking more closely at how well the treatment works while continuing safety checks. The trial status is Authorised, and the planned enrollment is 218 participants.
Key patient terms
Interventional study means the researchers give participants a study treatment and then measure the results. A cohort is a group of participants in the study who share a similar condition or treatment plan.
Prednisone and prednisolone are used in some study groups, while other groups are tested without steroids. The trial also records ECGs, which are heart tracing tests, and vital signs, such as blood pressure and pulse.
Laboratory results include chemistry, hematology, and urinalysis. Chemistry checks substances in blood, hematology looks at blood cells, and urinalysis examines urine.