Table of Contents
- Trial overview
- Who can participate
- What is being measured
- Trial design and treatment groups
- Phase and study status
- Key patient terms
Trial overview
The available clinical trial for ABIRATERONE DECANOATE is a Phase 2 interventional study in prostate cancer.[1] It is designed to learn more about how well the study treatment works and how safe it is in different groups of participants.[1]
The trial includes people with metastatic castration-resistant prostate cancer (mCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC).[1] These are two advanced forms of prostate cancer, and the study looks at them in separate cohorts, or participant groups.[1]
Who can participate
The study includes ARPI-naïve participants, which means people who have not used an androgen receptor pathway inhibitor before.[1] One part of the study focuses on ARPI-naïve mCRPC participants, while another focuses on ARPI-naïve mHSPC participants.[1]
The trial also includes a safety run-in for mHSPC participants and a safety cohort for Japanese participants with mCRPC or mHSPC.[1] A safety run-in is an early part of a study used to check safety before moving to the main evaluation.[1]
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.[1] Baseline means the starting point before treatment begins.[1]
In the mHSPC cohort, the study measures the proportion of participants with PSA at 0.2 ng/mL or lower at 8 months.[1] PSA is a blood marker used to follow prostate cancer activity.[1]
Safety outcomes include dose-limiting toxicities, adverse events, serious adverse events, laboratory results, electrocardiograms, vital signs, physical examinations, and ECOG performance status scores.[1] Adverse events are unwanted medical problems that happen during a study, and serious adverse events are the more severe ones.[1]
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.[1] This helps researchers see whether the treatment can be given without certain hormone-related problems.[1]
Trial design and treatment groups
The trial compares ASP5541-based treatment with abiraterone acetate-based treatment in some cohorts.[1] 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.[1]
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.[1] In Cohort 3, the study looks at safety in Japanese mCRPC or mHSPC participants using ASP5541 with prednisone or prednisolone.[1]
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.[1]
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.[1] The trial status is Authorised, and the planned enrollment is 218 participants.[1]
Key patient terms
Interventional study means the researchers give participants a study treatment and then measure the results.[1] A cohort is a group of participants in the study who share a similar condition or treatment plan.[1]
Prednisone and prednisolone are used in some study groups, while other groups are tested without steroids.[1] The trial also records ECGs, which are heart tracing tests, and vital signs, such as blood pressure and pulse.[1]
Laboratory results include chemistry, hematology, and urinalysis.[1] Chemistry checks substances in blood, hematology looks at blood cells, and urinalysis examines urine.[1]
