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Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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.
Official title: Radiotherapy or Radical Prostatectomy Combined With Intense Androgen Deprivation Therapy for Newly Diagnosed Metastatic Prostate Cancer: A Multi-center Randomized Controlled Phase II Trial
Key Details
Gender
MALE
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
144
Start Date
2024-08-01
Completion Date
2028-07-31
Last Updated
2025-05-28
Healthy Volunteers
No
Conditions
Interventions
Intense androgen deprivation therapy
Patients received ADT plus second-generation ARi (enzalutamide, apalutamide, darolutamide or rezvilutamide) for 2 years.
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.
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.
Locations (1)
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, China