NCT06992232

Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This multi-center randomized controlled phase II trial was carried out in several hospitals in China to evaluate the efficacy and safety of radiotherapy or radical prostatectomy combined with intense androgen deprivation therapy for newly diagnosed metastatic prostate cancer.

Conditions

• Prostate Cancer Metastatic Disease

Interventions

Type	Name	Description
DRUG	Intense androgen deprivation therapy	Patients received ADT plus second-generation ARi (enzalutamide, apalutamide, darolutamide or rezvilutamide) for 2 years.
RADIATION	Radiation Therapy	Those allocated radiotherapy received 70Gy/2.8Gy/25f schedule for primary tumor and 70Gy/2.6-2.8Gy/25f or 37.5Gy/7.5Gy/5f for metastatic lymph nodes and bone lesions based on the size and location. Radiation should be finished within 2 years' systemic therapy.
PROCEDURE	radical prostatectomy	Those allocated surgery received robot-assisted laparoscopic radical prostaectomy plus extended pelvic lymph node dissection for local treatment. Surgery should be finished within 2 years' systemic therapy.

Timeline

• Start date: 2024-08-01
• Primary completion: 2027-07-31
• Completion: 2028-07-31
• First posted: 2025-05-28
• Last updated: 2025-05-28

Locations

1 site across 1 country: China