RecruitingPhase 2NCT06992232

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


Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

144 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment strategies — surgery versus radiation — combined with intensive hormone therapy for men with low-volume metastatic prostate cancer detected on advanced imaging scans. **You may be eligible if...** - You have confirmed prostate cancer that has spread to 10 or fewer sites visible on a PSMA PET scan (an advanced nuclear medicine scan) - There is no spread to internal organs (visceral metastases) - Your testosterone level is not in the castration range (or has only been in that range for 3 months or less) - Your primary prostate tumor can be surgically removed - You are in good physical condition (ECOG 0–1) **You may NOT be eligible if...** - You have already received more than 3 months of hormone therapy or had surgery, radiation, or chemotherapy for prostate cancer - You have severe heart disease or uncontrolled diabetes - You have another cancer in the past 5 years (with some exceptions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntense androgen deprivation therapy

Patients received ADT plus second-generation ARi (enzalutamide, apalutamide, darolutamide or rezvilutamide) for 2 years.

RADIATIONRadiation 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.

PROCEDUREradical 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

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NCT06992232


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