Clinical Trial

COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer

Study acronym: COAction
Active, Not Recruiting Phase 4
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Record status
This record was last updated February 11, 2026 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
Summary
A Randomized Trial of Neoadjuvant Leuprorelin, Darolutamide or Both Prior to Radical Prostatectomy for Intermediate or High-risk Prostate Cancer. Prospective, randomized, parallel group, open-label with blinded endpoint adjudication multicenter clinical trial.To assess, among patients with unfavorable intermediate to high-risk prostate cancer, whether a neoadjuvant combined treatment with leuprorelin (Leuprorelin) and darolutamide is superior to monotherapy in terms of complete or almost complete pathological response.A total of 144 patients with unfavorable intermediate to high-risk prostate cancer scheduled for radical prostatectomy with extended pelvic lymph node dissection will be randomized 1:1:1 to oral darolutamide, SC leuprorelin (Leuprorelin) or both (48 patients per arm) for 24 weeks.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-10-03; most recent amendment 2026-02-10.
Status change: Recruiting → Active, Not Recruiting 2026-02-10
Status change: Not Yet Recruiting → Recruiting 2025-05-20
Trial Details
NCT Number NCT06627530
Lead Sponsor Brazilian Clinical Research Institute
Collaborators: Bayer
Conditions Prostate Cancer
Enrollment 144 participants
Start Date 2025-02-17
Primary Completion 2026-03 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-02-11