Radiotherapy After Prostatectomy for Node Positive Prostate Cancer

Official title

Radiotherapy and Androgen Deprivation Therapy Versus Androgen Deprivation Therapy Alone After Prostatectomy for Node Positive Prostate Cancer (RADVAN): A Multicenter, Randomized Controlled Phase Ⅲ Trial

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.

Interventions

• Drug Androgen 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.
• Radiation radiotherapy
  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.

Primary outcome measures

• Biochemical progression-free survival [Time frame: 5 years]

Secondary outcome measures (12)

• Clinical recurrence-free survival [Time frame: 5 years]
• Locoregional failure free survival [Time frame: 5 years]
• Metastasis-free survival [Time frame: 5 years]
• Post-operative biochemical progression-free survival [Time frame: 5 years]
• Freedom from non-protocol hormone therapy [Time frame: 5 years]
• Freedom from castration resistance survival [Time frame: 5 years]
• Overall survival [Time frame: 5 years]
• Prostate cancer-specific survival [Time frame: 5 years]
• Adverse Events [Time frame: 5 years]
• Health-Related Quality of Life [Time frame: 5 years]
• Prostate Cancer-Specific Quality of Life [Time frame: 5 years]
• Anxiety and Depression [Time frame: 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 13 centers

• Dongguan People's Hospital — Dongguan
• Sun Yat-sen University Cancer Center — Guangzhou
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou
• Affiliated Hospital of Guangdong Medical University — Zhanjiang
• Henan Cancer Hospital — Zhengzhou
• West China Hospital, Sichuan University — Chengdu
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
• … and 5 more centers

Identifiers

NCT: NCT07477626 · 2025-FXY-409 · B2025-816

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗