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.
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.
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.
Parallel
Androgen Deprivation Therapy (ADT)
DrugAndrogen deprivation therapy includes available GnRH agonists and antagonists, such as Triptorelin, Leuprolide, Goserelin and Degarelix. No novel hormonal therapy is allowed.
radiotherapy
RadiationRadiotherapy 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.
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.
Clinical recurrence-free survival
The time from randomization to first radiographic progression or death from any cause.
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.
Metastasis-free survival
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 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.
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