Radiotherapy After Prostatectomy for Node Positive Prostate Cancer

NCT07477626 | Recruiting Phase 3

• 2 other identifiers: 2025-FXY-409B2025-816
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Prostate Cancer (Post Prostatectomy); Radiotherapy; Image-Guided; Prostate Cancer Non-Metastatic; Androgen Deprivation Therapy; Lymph Node Positive

Keywords

prostate cancer; node positive; pN1; radiotherapy; androgen deprivation therapy; hormone therapy; prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Clinical recurrence-free survival

  5 years

• Locoregional failure free survival

  5 years

• Metastasis-free survival

  5 years

• Post-operative biochemical progression-free survival

  5 years

• Freedom from non-protocol hormone therapy

  5 years

Study Arms (2)

Radiotherapy arm

EXPERIMENTAL

Patients will receive pelvic radiotherapy and androgen deprivation therapy for 2 years.

Drug: Androgen Deprivation Therapy (ADT); Radiation: radiotherapy

ADT arm

ACTIVE COMPARATOR

Patients will receive androgen deprivation therapy alone for 2 years.

Drug: Androgen Deprivation Therapy (ADT)

Interventions

radiotherapy RADIATION

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.

Radiotherapy arm

Androgen Deprivation Therapy (ADT) DRUG

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

ADT arm; Radiotherapy arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (13)

Dongguan People's Hospital

Dongguan, Guangdong, China

NOT YET RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

NOT YET RECRUITING

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

NOT YET RECRUITING

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

NOT YET RECRUITING

Beijing Hospital

Beijing, China

RECRUITING

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

NOT YET RECRUITING

Peking University First Hospital

Beijing, China

RECRUITING

Peking University Third Hospital

Beijing, China

NOT YET RECRUITING

The First Affiliated Hospital of Naval Medical University

Shanghai, China

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutics

Study Officials

• Liru He, PhD

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liru He, PhD

CONTACT

+862087343030; helir@sysucc.org.cn

Yang Liu, MD

CONTACT

+862087341521; liuyang1@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: March 17, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): December 31, 2038
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)