ProA Study: ProActive Management Model in Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated by Apalutamide

This is a Phase 4, multi-center, single arm, open-label clinical study to evaluate whether participants with mHSPC treated with apalutamide will benefit from the 4A ProActive Management Model. The study will include a Screening Period of up to 14 days before assignment on Day 1 to establish study eligibility. Participants will get 4A ProActive Management according to the protocol . As the background disease treatment, participants will received apalutamide according to local label (240 mg, 4 × 60 mg tablets, orally once daily with or without food) with duration of at least 6 months. Participants will have a Safety Follow-Up Visit within 30 days after the Visit 7. Participants will be monitored for safety, starting from the time of signing the informed consent until 30 days after the Visit 7. AEs including laboratory AEs will be graded and summarized using Version 5.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events.

NCT Number	NCT06865547
Lead Sponsor	Yonghong Li
Conditions	Prostate Cancer (Adenocarcinoma)
Enrollment	94 participants
Start Date	2025-01-22
Primary Completion	2026-01-30 (estimated)
Study Completion	2026-08-30 (estimated)
Updated on ClinicalTrials.gov	2025-03-10