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โ† Trials
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Radiotherapy After Prostatectomy for Node Positive Prostate Cancer

RecruitingPhase 3Ages 18 Years - anyMaleSun Yat-sen University
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In plain words

What the trial is, and whether it could suit you

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 pros

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 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 โ‰ฅ 90 g/L Platelet count โ‰ฅ 75 ร— 10โน/L Total bilirubin โ‰ค 3 ร— ULN AST or ALT โ‰ค 5 ร— 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 โ‰ค 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.
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What it tests

  • Androgen Deprivation Therapy (ADT)
  • radiotherapy
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Where

13 sites
Dongguan People's Hospital
Dongguan, China
Sun Yat-sen University Cancer Center
Guangzhou, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, China
Henan Cancer Hospital
Zhengzhou, China
West China Hospital, Sichuan University
Chengdu, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China

โ€ฆand 5 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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