Phase III Study Comparing Rezvilutamide and Enzalutamide with Androgen Deprivation Therapy for Low-Volume Metastatic Hormone-Sensitive Prostate Cancer in Adult Men

What this Trial Is About

Researchers are evaluating the efficacy and safety of rezvilutamide compared to enzalutamide in treating men with low-volume metastatic hormone-sensitive prostate cancer. This phase III, multicenter study focuses on patients with prostate adenocarcinoma who are beginning androgen deprivation therapy and aims to assess their response to these treatments over time. Participants are randomly assigned to receive either oral rezvilutamide tablets or enzalutamide soft capsules, both combined with androgen deprivation therapy. The study is open-label, so both patients and researchers know which treatment is given. The treatment period and evaluations will continue for up to approximately five years to monitor outcomes and safety. During the trial, patients will undergo regular assessments including prostate-specific antigen PSA testing, imaging scans to measure tumor progression, and monitoring for side effects. The main outcome measured is the rate of undetectable PSA levels six months after starting treatment. Researchers will also track overall survival, time to disease progression, and adverse events throughout the study. Participation involves scheduled visits and laboratory tests over multiple years, with close monitoring to ensure safety and collect comprehensive data.

A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer