NCT06627530

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

A Randomized Trial of Neoadjuvant Leuprorelin, Darolutamide or Both Prior to Radical Prostatectomy for Intermediate or High-risk Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Brazilian Clinical Research Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Darolutamide Oral Tablet	darolutamide 600 mg PO BID for 24 weeks
DRUG	leuprorelin	leuprorelin depot 22.5 mg SC every 12 weeks

Timeline

• Start date: 2025-02-17
• Primary completion: 2026-03-01
• Completion: 2026-09-01
• First posted: 2024-10-04
• Last updated: 2026-02-11

Locations

6 sites across 1 country: Brazil