Androgen Deprivation Therapy, Lymph Node Positive, Prostate Cancer Non-Metastatic, Prostate Cancer (Post Prostatectomy), Radiotherapy; Image-Guided
Conditions
Keywords
prostate cancer, node positive, pN1, radiotherapy, androgen deprivation therapy, hormone therapy, prostatectomy
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.
Interventions
DRUGAndrogen Deprivation Therapy (ADT)
Androgen deprivation therapy includes available GnRH agonists and antagonists, such as Triptorelin, Leuprolide, Goserelin and Degarelix. No novel hormonal therapy is allowed.
RADIATIONradiotherapy
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.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Statistician
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical progression-free survival | 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical recurrence-free survival | 5 years | The time from randomization to first radiographic progression or death from any cause. |
| Locoregional failure free survival | 5 years | 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 | 5 years | 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 | 5 years | 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. |
| Freedom from non-protocol hormone therapy | 5 years | 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. |
| Freedom from castration resistance survival | 5 years | Time from randomization to CRPC or death from any cause, with CRPC defined according to PCWG3 criteria. |
| Overall survival | 5 years | The time from randomization to death from any cause. |
| Prostate cancer-specific survival | 5 years | The time from randomization to death directly attributable to prostate cancer. |
| Adverse Events | 5 years | Adverse events assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. |
| Health-Related Quality of Life | 5 years | 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). |
| Prostate Cancer-Specific Quality of Life | 5 years | Changes from baseline in prostate cancer-specific quality of life measured using the EORTC QLQ-PR25 module. |
| Anxiety and Depression | 5 years | Changes from baseline in anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS). |
Countries
China
Contacts
CONTACTLiru He, PhD
CONTACTYang Liu, MD
PRINCIPAL_INVESTIGATORLiru He, PhD
Sun Yat-Sen University Cancer Center
Outcome results
None listed