Phase 3 Trial Comparing 6-Month vs Long-Term Rezvilutamide With ADT and Chemotherapy in Men With High Tumor Burden Metastatic Hormone-Sensitive Prostate Cancer

What this Trial Is About

Researchers are studying men with high tumor burden metastatic hormone-sensitive prostate cancer mHSPC to compare two treatment durations of Rezvilutamide combined with androgen deprivation therapy ADT and chemotherapy. The study aims to determine if a 6-month course of Rezvilutamide is not worse than a longer-term treatment in improving the time patients live without their cancer getting worse on scans. It also looks at other outcomes like PSA progression, bone-related events, and quality of life. Participants will be randomly assigned to receive either a 6-month or a long-term course of Rezvilutamide alongside ADT and six cycles of docetaxel chemotherapy. The treatments are given as part of a triple therapy regimen, and the study is open-label, meaning both participants and researchers know which treatment is given. The trial lasts around three years, during which patients are monitored closely. Throughout the study, participants will have regular assessments including imaging to check cancer progression, blood tests to measure PSA levels, and evaluations of bone-related complications. Quality of life questionnaires will also be completed. Researchers will track the occurrence of side effects and measure how long patients remain free from disease progression. Follow-up visits will continue up to 36 months to gather comprehensive data on treatment impact and safety.

Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in mHSPC