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.
Radiotherapy After Prostatectomy for Node Positive Prostate Cancer
Status
Recruiting
Phase
Phase 3
Enrollment
372
Locations
13
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
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.
Timeline
From registration to results.
First posted
Mar 17, 2026
Study start
Mar 20, 2026
Primary completion
Dec 31, 2033
Study completion
Dec 31, 2038
Results posted
Not reported
Registry updated
Jun 16, 2026
Outcomes
What the study measures.
Primary outcomes
Biochemical progression-free survival
Time frame · 5 years
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.
Secondary outcomes
Clinical recurrence-free survival
Time frame · 5 years
The time from randomization to first radiographic progression or death from any cause.
Locoregional failure free survival
Time frame · 5 years
The time from randomization to the first occurrence of locoregional recurrence (prostate bed or pelvic lymph nodes) or death from any cause.
Metastasis-free survival
Time frame · 5 years
The time from randomization to the first occurrence of distant metastasis (excluding pelvic lymph nodes) or death from any cause.
Post-operative biochemical progression-free survival
Time frame · 5 years
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.
Freedom from non-protocol hormone therapy
Time frame · 5 years
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.
Freedom from castration resistance survival
Time frame · 5 years
Time from randomization to CRPC or death from any cause, with CRPC defined according to PCWG3 criteria.
Overall survival
Time frame · 5 years
The time from randomization to death from any cause.
Prostate cancer-specific survival
Time frame · 5 years
The time from randomization to death directly attributable to prostate cancer.
Adverse Events
Time frame · 5 years
Adverse events assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Health-Related Quality of Life
Time frame · 5 years
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).
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- MALE
- Healthy volunteers
- No
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 locations
13 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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