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Radiotherapy After Prostatectomy for Node Positive Prostate Cancer

Study acronym: RADVAN
StatusRecruiting
PhasePhase 3
Started2026-03-20
View on ClinicalTrials.gov ↗

Amendment history

2026-06-15
notable
Study Status, Contacts/Locations v2
Trial status changed: Active, Not Recruiting → Recruiting
Trial sites expanded: 9 → 13 locations
Start date2026-01-06→2026-03-20
2026-05-14
minor
Study Status, Study Design, Outcome Measures, Eligibility v1
Enrollment target374→372
Eligibility criteria+86 characters
[...] year if receiving postoperative androgen deprivation therapy*. Adequate major organ function, defined as: Hemoglobin ≥ 90 [...] ty 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 postoper [...]
Secondary endpoints11 to 12 entries
Post-operative biochemical progression-free survival
2026-03-12
minor
Original filing
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.
Trial Details
NCT Number NCT07477626
Lead Sponsor Sun Yat-sen University
Conditions Prostate Cancer (Post Prostatectomy), Radiotherapy; Image-Guided, Prostate Cancer Non-Metastatic, Androgen Deprivation Therapy, Lymph Node Positive
Enrollment 372 participants
Start Date 2026-03-20
Primary Completion 2033-12-31 (estimated)
Study Completion 2038-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-16