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

NCT04916613 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-04-28

No results posted yet for this study

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.

Conditions

  • Prostate Cancer Metastatic

Interventions

DRUG

Darolutamide 300 mg

600 mg po, b.i.d.

DRUG

Placebo

po, b.i.d.

DRUG

Androgen deprivation therapy

Use according to local standard of care

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • Karim Fizazi, MD · Gustave Roussy Cancer Campus, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2028-03-31
Completion
2037-09-30

Countries

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

Study Locations

More Related Trials

Entities

Drugs
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 NCT04916613 on ClinicalTrials.gov