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

NCT06627530 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2026-02-11

No results posted yet for this study

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

Interventions

DRUG

Darolutamide Oral Tablet

darolutamide 600 mg PO BID for 24 weeks

DRUG

leuprorelin

leuprorelin depot 22.5 mg SC every 12 weeks

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Brazilian Clinical Research Institute

    lead OTHER

Principal Investigators

  • Fernando C Maluf, MD · Brazilian Clinical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-17
Primary Completion
2026-03-31
Completion
2026-09-30

Countries

  • Brazil

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06627530 on ClinicalTrials.gov