Radiotherapy After Prostatectomy for Node Positive Prostate Cancer

Phase 3Active Not RecruitingNCT07477626

Sun Yat-sen University374 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

374

Conditions

Prostate Cancer (Post Prostatectomy)Radiotherapy; Image-Guided

Interventions

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.

radiotherapyRADIATION

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.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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. 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.

Locations (9)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, 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

Outcomes

Primary Outcomes

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.

Time frame: 5 years

Secondary Outcomes

Clinical recurrence-free survival

The time from randomization to first radiographic progression or death from any cause.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 5 years

Freedom from castration resistance survival

Time from randomization to CRPC or death from any cause, with CRPC defined according to PCWG3 criteria.

Time frame: 5 years

Overall survival

The time from randomization to death from any cause.

Time frame: 5 years

Prostate cancer-specific survival

The time from randomization to death directly attributable to prostate cancer.

Time frame: 5 years

Adverse Events

Adverse events assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

Time frame: 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).

Time frame: 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.

Time frame: 5 years

Anxiety and Depression

Changes from baseline in anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS).

Time frame: 5 years