Adding Pelvic Radiotherapy to Hormone Therapy After Prostate Surgery for Prostate Cancer
Tests adding pelvic radiotherapy to hormone therapy in men with lymph node-positive prostate cancer.
Plain-language title generated from the registry record
Registry title: Radiotherapy After Prostatectomy for Node Positive Prostate Cancer
Key facts
- Where
- Beijing, Chengdu, Dongguan, Guangzhou, Hangzhou, Shanghai, Zhanjiang, and Zhengzhou, ChinaSee the 13 sites
- Phase
- Phase 3
Where in China
- Beijing HospitalBeijing, ChinaTaking people
- Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaNot yet recruiting
- Peking University First HospitalBeijing, ChinaTaking people
- Peking University Third HospitalBeijing, ChinaNot yet recruiting
- West China Hospital，Sichuan UniversityChengdu, ChinaTaking people
- Dongguan People's HospitalDongguan, ChinaNot yet recruiting
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaTaking people
- The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaNot yet recruiting
- The First Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaNot yet recruiting
- The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaNot yet recruiting
- The First Affiliated Hospital of Naval Medical UniversityShanghai, ChinaNot yet recruiting
- Affiliated Hospital of Guangdong Medical UniversityZhanjiang, ChinaNot yet recruiting
- Henan Cancer HospitalZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sun Yat-sen University
- Trial code
- NCT07477626
- Record updated
- 16 June 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Age ≥ 18 years; Histologically confirmed adenocarcinoma of the prostate; Radical prostatectomy with pelvic lymph node dissection and pathologically confirmed positive pelvic lymph nodes (AJCC 8th edition: external iliac, internal iliac, obturator, presacral, periprostatic, and/or perirectal nodes); ECOG performance status 0-2; Started postoperative GnRH agonist or antagonist therapy for less than 1 year if receiving postoperative androgen deprivation therapy*; Adequate major organ function, defined as:; Hemoglobin ≥ 90 g/L Platelet count ≥ 75 × 10⁹/L Total bilirubin ≤ 3 × ULN AST or ALT ≤ 5 × ULN; Use of effective contraception during the study and for 3 months after; Written informed consent provided, with willingness and ability to comply with study visits, treatments, and procedures; Prior postoperative ARAT use ≤ 3 months is eligible after treatment discontinuation.
Exclusion: Neoadjuvant hormonal therapy > 3 months before prostatectomy; Castration-resistant prostate cancer (CRPC) prior to enrollment per 2025 EAU criteria; Prior radiotherapy overlapping irradiation fields that may compromise normal tissue; Malignancy within 5 years that may interfere with study safety or efficacy assessments; Psychiatric disorders preventing understanding or compliance; Any condition that, in the investigator's judgment, makes participation unsuitable; Measurable pelvic recurrence on postoperative MRI or CT (RECIST 1.1, including prostate bed and lymph nodes); Radiographically confirmed distant metastasis (M1a, M1b, or M1c); Serious comorbidities affecting study treatment.