RecruitingPhase 3NCT07477626

Radiotherapy After Prostatectomy for Node Positive Prostate Cancer

Radiotherapy and Androgen Deprivation Therapy Versus Androgen Deprivation Therapy Alone After Prostatectomy for Node Positive Prostate Cancer (RADVAN): A Multicenter, Randomized Controlled Phase Ⅲ Trial


Sponsor

Sun Yat-sen University

Enrollment

372 participants

Start Date

Mar 20, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate whether the addition of pelvic radiotherapy to androgen deprivation therapy (ADT) can delay disease progression and improve survival outcomes in patients with pathologically confirmed regional lymph node-positive (pN1) prostate cancer after radical prostatectomy. The main questions it aims to answer are: * Does ADT combined with pelvic radiotherapy improve biochemical recurrence-free survival (bRFS) compared with ADT alone in pN1 patients? * Does the addition of pelvic radiotherapy improve clinical progression-free survival, metastasis-free survival, overall survival, and prostate cancer-specific survival without unacceptable toxicity? Researchers will compare ADT plus pelvic radiotherapy with ADT alone to see if combined treatment improves disease control and long-term clinical outcomes. Participants with positive lymph nodes after prostatectomy will be randomly assigned in a 2:1 ratio to receive ADT plus pelvic radiotherapy, or ADT alone. ADT will be administered for 2 years. Patients with radiologically detectable pelvic recurrence or distant metastases after radical prostatectomy will be excluded. Safety, adverse events, and health-related quality of life will be assessed during follow-up.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Androgen Deprivation Therapy (ADT) and radiotherapy for people with androgen deprivation therapy, lymph node positive, and other related conditions. The study is currently recruiting participants at 13 locations.

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

DRUGAndrogen Deprivation Therapy (ADT)

Androgen deprivation therapy includes available GnRH agonists and antagonists, such as Triptorelin, Leuprolide, Goserelin and Degarelix. No novel hormonal therapy is allowed.

RADIATIONradiotherapy

Radiotherapy will be administered using IMRT or VMAT techniques. Radiation fields will include the pelvic lymph node drainage areas, with inclusion of the prostate bed in patients with pT3-4 disease or positive surgical margins.


Locations(13)

Dongguan People's Hospital

Dongguan, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Beijing Hospital

Beijing, China

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

Peking University First Hospital

Beijing, China

Peking University Third Hospital

Beijing, China

The First Affiliated Hospital of Naval Medical University

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT07477626


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