Clinical Trial

ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)

Study acronym: GETUG-AFU 40
Recruiting Phase 3
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Summary
This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2021-06-04; most recent amendment 2026-04-22.
Status change: Not Yet Recruiting → Recruiting 2022-04-25
Trial Details
NCT Number NCT04916613
Lead Sponsor UNICANCER
Collaborators: Bayer
Conditions Prostate Cancer Metastatic
Enrollment 300 participants
Start Date 2022-04-19
Primary Completion 2028-03 (estimated)
Study Completion 2037-09 (estimated)
Updated on ClinicalTrials.gov 2026-04-28