Study Comparing Rezvilutamide with ADT and Docetaxel Versus Rezvilutamide with ADT Alone in Men Aged 40-80 With Metastatic Hormone-Sensitive Prostate Cancer

What this Trial Is About

Researchers are investigating whether adding docetaxel chemotherapy to a combination of Rezvilutamide and androgen deprivation therapy ADT improves overall survival in men with metastatic hormone-sensitive prostate cancer mHSPC. This phase 3 randomized controlled study aims to evaluate the value of chemotherapy alongside next-generation androgen receptor inhibitors in patients with a high tumor burden. Participants will be randomly assigned to one of two groups one receiving Rezvilutamide 240 mg daily tablets plus ADT and docetaxel chemotherapy for 6 cycles, and the other receiving Rezvilutamide plus ADT without chemotherapy. Rezvilutamide is taken orally once daily, with or without food. Treatment is studied over a planned period with careful monitoring of effects and safety. During the study, participants will undergo assessments including laboratory tests to monitor blood counts, kidney and liver function, and coagulation. Researchers will measure outcomes such as radiographic progression-free survival over 36 months, prostate-specific antigen PSA response rate, and time to castration-resistant prostate cancer. The study includes regular follow-ups to monitor health status and treatment response throughout the trial period.

Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the mHSPC