ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable) (NCT04916613)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Grand Hopital de Charleroi - site Notre Dame — Charleroi
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (95 Sites)
Showing the first 25 of 95 sites.
- Grand Hopital de Charleroi - site Notre Dame — Charleroi,
- Groupe Jolimont - Hôpital De Jolimont — Haine-Saint-Paul,
- CHU UCL NAMUR - Site STE. ELISABETH — Namur,
- Clinique Saint Pierre — Ottignies,
- Institut Sainte Catherine — Avignon,
- Centre Hospitalier Cote basque — Bayonne,
- CHU Besançon - Hopital Jean Mijoz — Besançon,
- Centre Pierre Curie — Beuvry,
- Centre Institut Bergonié — Bordeaux,
- Clinique Pasteur — Brest,
- Centre François Baclesse — Caen,
- Centre Hospitalier Métropole Savoie — Chambéry,
- Centre Jean Perrin — Clermont-Ferrand,
- CH Colmar — Colmar,
- APHP - Hôpital Henri Mondor — Créteil,
- Centre Georges François Leclerc — Dijon,
- CHU Grenoble — Grenoble,
- CHU Sud Réunion — La Réunion,
- Centre CHV Vendée — La Roche-sur-Yon,
- CHU le MANS — Le Mans,
- Centre Oscar Lambret — Lille,
- Polyclinique de Limoges — Limoges,
- Groupe Hospitalier Bretagne Sud — Lorient,
- Centre Léon Bérard — Lyon,
- Institut Paoli-Calmettes — Marseille,
📞 Contact the Study Coordinator
Phone: +33 (0) 1 85 34 31 13
Email: c-leger@unicancer.fr
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.