Radiotherapy After Prostatectomy for Node Positive Prostate Cancer (RADVAN)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Androgen Deprivation Therapy; Lymph Node Positive; Prostate Cancer Non-Metastatic; Radiotherapy; Image-Guided; Prostate Cancer (Post Prostatectomy)
• Intervention / Treatment: Drug: Androgen Deprivation Therapy (ADT); Radiation: radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 372
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University First Hospital
  • Beijing, China
    • Peking University Third Hospital
  • Beijing, China
    • Cancer Hospital, Chinese Academy of Medical Sciences
  • Beijing, China
    • Beijing Hospital
  • Shanghai, China
    • The First Affiliated Hospital of Naval Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-Sen University Cancer Center
    • Zhanjiang, Guangdong, China
      • Affiliated Hospital of Guangdong Medical University
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital, Sichuan University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The first Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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).
• Neoadjuvant hormonal therapy > 3 months before prostatectomy.
• Malignancy within 5 years that may interfere with study safety or efficacy assessments.
• Castration-resistant prostate cancer (CRPC) prior to enrollment per 2025 EAU criteria
• Prior radiotherapy overlapping irradiation fields that may compromise normal tissue.
• Serious comorbidities affecting study treatment.
• Psychiatric disorders preventing understanding or compliance.
• Any condition that, in the investigator's judgment, makes participation unsuitable.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiotherapy arm; Patients will receive pelvic radiotherapy and androgen deprivation therapy for 2 years.	Drug: Androgen 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.; Radiation: radiotherapy; 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.
Active Comparator: ADT arm; Patients will receive androgen deprivation therapy alone for 2 years.	Drug: Androgen 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical progression-free survival	Time from randomization to PSA ≥ 0.4 ng/mL with subsequent rise, PSA ≥ 1.0 ng/mL at any time, clinical or radiographic progression, or death from any cause.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical recurrence-free survival	The time from randomization to first radiographic progression or death from any cause.	5 years
Locoregional failure free survival	The time from randomization to the first occurrence of locoregional recurrence (prostate bed or pelvic lymph nodes) or death from any cause.	5 years
Metastasis-free survival	The time from randomization to the first occurrence of distant metastasis (excluding pelvic lymph nodes) or death from any cause.	5 years
Freedom from non-protocol hormone therapy	Time from randomization to initiation of non-protocol-specified hormonal therapy, including additional hormonal agents or re-initiation of castration therapy without meeting progression criteria.	5 years
Freedom from castration resistance survival	Time from randomization to CRPC or death from any cause, with CRPC defined according to PCWG3 criteria.	5 years
Overall survival	The time from randomization to death from any cause.	5 years
Prostate cancer-specific survival	The time from randomization to death directly attributable to prostate cancer.	5 years
Adverse Events	Adverse events assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.	5 years
Health-Related Quality of Life	Changes from baseline in global health status and functional/symptom scores measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).	5 years
Prostate Cancer-Specific Quality of Life	Changes from baseline in prostate cancer-specific quality of life measured using the EORTC QLQ-PR25 module.	5 years
Anxiety and Depression	Changes from baseline in anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS).	5 years
Post-operative biochemical progression-free survival	Time from surgery to PSA ≥ 0.4 ng/mL with subsequent rise, PSA ≥ 1.0 ng/mL at any time, clinical or radiographic progression, or death from any cause.	5 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Liru He, PhD, Sun Yat-Sen University Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2026
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): December 31, 2038

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: prostate cancer; radiotherapy; hormone therapy; node positive; androgen deprivation therapy; prostatectomy; pN1
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Therapeutics; Pharmacologic Actions; Chemical Actions and Uses; Androgen Antagonists; Radiotherapy
• Other Study ID Numbers: 2025-FXY-409; B2025-816 (Other Identifier: Sun Yat-sen University Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to local law

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No