drugset / Trial / NCT04916613

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

NCT04916613

Phase 3 Recruiting 300 enrolled UNICANCER Bayer · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2022-04-19
Primary completion
2028-03
Completion
2037-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Darolutamide Other / unclassified 600 mg Oral