NCT07477626RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 372 (estimated)
- First submitted
- 28 Jan 2026
- Start date
- 20 Mar 2026
- Primary completion date
- 31 Dec 2033
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Prostate cancer
- NCT number
- NCT07477626
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 372
- From 20 Mar 2026 to the primary completion date, 31 Dec 2033
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Beijing Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| West China Hospital，Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Dongguan People's Hospital Coordinator of this site? Confirm its status | Dongguan | China | Not yet recruiting |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Not yet recruiting |
| The First Affiliated Hospital of Naval Medical University Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Affiliated Hospital of Guangdong Medical University Coordinator of this site? Confirm its status | Zhanjiang | China | Not yet recruiting |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.