Rezvilutamide for High-Risk Prostate Cancer After Surgery

\[Study Rationale \& Background\] High-risk prostate cancer is typically defined by factors including clinical stage (e.g., cT3-4), a Gleason score of 8 or higher, and Prostate-Specific Antigen (PSA) levels greater than 20 ng/mL. Patients meeting these criteria face a significant risk of recurrence after radical prostatectomy (RP). While adjuvant radiotherapy is a standard option, many patients cannot tolerate or choose not to undergo radiation. This study explores an intensive endocrine therapy approach using Rezvilutamide, a potent new-generation oral androgen receptor (AR) inhibitor, combined with standard Androgen Deprivation Therapy (ADT). \[Study Design \& Intervention\] This is an exploratory, prospective, single-arm clinical study. After enrollment, participants will receive a combination therapy of standard-dose Rezvilutamide (240 mg once daily, orally) and ADT (Leuprorelin 3.75 mg subcutaneous injection, once every 4 weeks). Each treatment cycle lasts 28 days. After completing 12 cycles of the combination therapy, participants will proceed to monotherapy with standard-dose Rezvilutamide for maintenance. The total duration of treatment will be up to 24 cycles. The primary objective is to evaluate the 3-year biochemical recurrence-free survival (BCRFS) rate. \[Safety \& Exploratory Objectives\] Secondary objectives focus on the 36-month metastasis-free survival (MFS) rate and a comprehensive safety profile. This includes monitoring the types, grades, and incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), and Adverse Events of Special Interest (AESIs). Additionally, the study includes an exploratory analysis of immune cell status to characterize the biological impact of Rezvilutamide on the patient's immune environment during treatment. \[Quality of Life\] Patient-reported outcomes and quality of life will be monitored throughout the study using standardized assessment tools, including the FACT-P, EPIC-26, and BPI-SF scales, to ensure a holistic evaluation of the treatment's impact on physical and emotional well-being.