Radiotherapy after prostate removal for node-positive prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial compares two treatment strategies in men with pathologically confirmed positive pelvic lymph nodes after radical prostatectomy. Participants are randomized in a 2:1 ratio to receive androgen deprivation therapy (ADT) alone or ADT plus pelvic radiotherapy. The goal is to see if adding pelvic radiotherapy improves biochemical recurrence-free survival and other long-term outcomes such as progression-free, metastasis-free, overall, and cancer-specific survival, while monitoring toxicity. Eligible patients must have completed prostatectomy with positive lymph nodes, good performance status, and adequate organ function. Prior ARAT use after surgery is allowed if discontinued before enrollment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting
• West China Hospital, Sichuan University
  Chengdu, Sichuan, China Recruiting
• Beijing Hospital
  Beijing, China Recruiting
• Peking University First Hospital
  Beijing, China Recruiting
• Dongguan People's Hospital
  Dongguan, Guangdong, China Not yet recruiting

Study contacts

• Principal investigator: Liru He, PhD — Sun Yat-Sen University Cancer Center
• Study coordinator: Liru He, PhD
• Email: helir@sysucc.org.cn
• Phone: +862087343030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.