Radiotherapy After Prostatectomy for Node Positive Prostate Cancer (RADVAN)

Sun Yat-sen University

Status and phase: Active, not recruiting; Phase 3

Conditions: Prostate Cancer (Post Prostatectomy); Lymph Node Positive; Androgen Deprivation Therapy; Radiotherapy; Image-Guided; Prostate Cancer Non-Metastatic

Treatments: Drug: Androgen Deprivation Therapy (ADT); Radiation: radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07477626

2025-FXY-409

B2025-816 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 374 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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374 participants in 2 patient groups

Radiotherapy arm

Experimental group

Description:

Patients will receive pelvic radiotherapy and androgen deprivation therapy for 2 years.

Treatment:

Radiation: radiotherapy

Drug: Androgen Deprivation Therapy (ADT)

ADT arm

Active Comparator group

Description:

Patients will receive androgen deprivation therapy alone for 2 years.

Treatment:

Drug: Androgen Deprivation Therapy (ADT)