A Double-blind Randomised Phase III Trial Evaluating the Efficacy of ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability and Not Elected for Docetaxel or Androgen Receptor Targeted Agents (GETUG-AFU 40)

NCT04916613 Phase 3 RECRUITING

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.

Details

Lead sponsor	UNICANCER
Phase	Phase 3
Status	RECRUITING
Enrolment	300
Start date	2022-04-19
Completion	2037-09

Conditions

• Prostate Cancer Metastatic

Interventions

• Darolutamide 300 mg
• Placebo
• Androgen deprivation therapy

Primary outcomes

• Radiographic progression-free survival — From randomisation to radiographic progression or death, up to 18 months
  Time from randomisation to radiographic progression according to the Prostate Cancer Working Group 3 (PCWG3) criteria or death, whichever occurs first

Countries

Belgium, France, Germany, Ireland, Italy, Martinique, Netherlands, Romania, Slovakia, Spain, Sweden, Switzerland