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

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.

Trial Details

NCT ID
NCT04916613
Phase
PHASE3
Sponsor
UNICANCER
Status
RECRUITING
Cancer Type
Castration-Resistant (CRPC) Prostate Cancer
Interventions
  • Darolutamide 300 mg
  • Placebo
  • Androgen deprivation therapy
Locations (sample)
  • Charleroi, Belgium|50.41136,4.44448
  • Haine-Saint-Paul, Belgium|50.45544,4.1885
  • Namur, Belgium|50.4669,4.86746
  • Ottignies, Belgium|50.66535,4.56679
  • Avignon, France|43.94834,4.80892

Key Eligibility Criteria

  • Signed a written informed consent form prior to any trial specific procedures.
  • Men with histologically or cytologically confirmed adenocarcinoma of the prostate.
  • Aged ≥18 years old at the time of signing informed consent.
  • De novo metastatic disease defined by clinical or radiological evidence of metastases.

For full eligibility, visit ClinicalTrials.gov.

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