Radiotherapy or Radical Prostatectomy Combined With Intense Androgen Deprivation Therapy for Newly Diagnosed Metastatic Prostate Cancer: A Multi-center Randomized Controlled Phase II Trial

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining radiotherapy or radical prostatectomy with intense androgen deprivation therapy for men newly diagnosed with metastatic prostate cancer. This phase II randomized controlled trial is conducted across multiple hospitals in China to better understand treatment outcomes for this condition. Participants receive intense androgen deprivation therapy, which includes androgen deprivation therapy plus second-generation androgen receptor inhibitors such as enzalutamide, apalutamide, darolutamide, or rezvilutamide for two years. In the experimental group, patients receive local treatment in addition to this systemic therapy. Local treatment can be either radiotherapy, delivered in specific doses over several sessions to the primary tumor and metastatic sites, or robot-assisted laparoscopic radical prostatectomy with extended pelvic lymph node dissection. All local treatments are completed within the two-year systemic therapy period. During the study, participants are closely monitored through various evaluations to measure outcomes such as event-free survival at two years, progression-free survival, time to castration-resistant prostate cancer, and adverse events over four years. The trial involves regular assessments including physical condition scoring and laboratory tests to ensure safety and track disease progression. Total participation may last several years to capture long-term results and treatment effects.

Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC