RecruitingPhase 3NCT04916613

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

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


Sponsor

UNICANCER

Enrollment

300 participants

Start Date

Apr 19, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding darolutamide (a hormone-blocking pill) to standard hormone therapy improves outcomes in older or frail men newly diagnosed with prostate cancer that has already spread to other parts of the body. **You may be eligible if:** - You are a man 18 or older newly diagnosed with metastatic prostate cancer (cancer that has spread) - You are too frail or unwell to receive more intensive treatments like docetaxel, abiraterone, or enzalutamide - You meet at least one frailty marker (e.g., difficulty with daily activities, low BMI, slow walking, or recent weight loss) - Your blood counts and organ function are adequate **You may NOT be eligible if:** - You are severely frail or have 3 or more serious medical problems on a geriatric assessment - You have very poor performance status (mostly in bed or chair) - Your blood pressure is uncontrolled - You had a stroke, heart attack, or severe heart failure in the past 6 months - You have another active cancer - You cannot swallow oral medication - You have active hepatitis, HIV, or severe liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDarolutamide 300 mg

600 mg po, b.i.d.

DRUGPlacebo

po, b.i.d.

DRUGAndrogen deprivation therapy

Use according to local standard of care


Locations(95)

Grand Hopital de Charleroi - site Notre Dame

Charleroi, Belgium

Groupe Jolimont - Hôpital De Jolimont

Haine-Saint-Paul, Belgium

CHU UCL NAMUR - Site STE. ELISABETH

Namur, Belgium

Clinique Saint Pierre

Ottignies, Belgium

Institut Sainte Catherine

Avignon, France

Centre Hospitalier Cote basque

Bayonne, France

CHU Besançon - Hopital Jean Mijoz

Besançon, France

Centre Pierre Curie

Beuvry, France

Centre Institut Bergonié

Bordeaux, France

Clinique Pasteur

Brest, France

Centre François Baclesse

Caen, France

Centre Hospitalier Métropole Savoie

Chambéry, France

Centre Jean Perrin

Clermont-Ferrand, France

CH Colmar

Colmar, France

APHP - Hôpital Henri Mondor

Créteil, France

Centre Georges François Leclerc

Dijon, France

CHU Grenoble

Grenoble, France

CHU Sud Réunion

La Réunion, France

Centre CHV Vendée

La Roche-sur-Yon, France

CHU le MANS

Le Mans, France

Centre Oscar Lambret

Lille, France

Polyclinique de Limoges

Limoges, France

Groupe Hospitalier Bretagne Sud

Lorient, France

Centre Léon Bérard

Lyon, France

Institut Paoli-Calmettes

Marseille, France

CH Mont De Marsan

Mont-de-Marsan, France

Centre Azuréen de Cancérologie

Mougins, France

Centre Antoine Lacassagne

Nice, France

CHU Nîmes

Nîmes, France

Centre Groupe Hospitalier Diaconesses Croix Saint-Simon

Paris, France

Hôpital Saint Louis

Paris, France

Hôpital Européen Georges Pompidou

Paris, France

Hôpital Tenon

Paris, France

Hospices Civils de Lyon -Lyon Sud

Pierre-Bénite, France

CHU de Poitiers - Pôle Régional de Cancérologie

Poitiers, France

CH Annecy Genevois

Pringy, France

CHIC Quimper

Quimper, France

Institut Jean Godinot

Reims, France

Centre Eugène Marquis

Rennes, France

Centre Eugène Marquis - Rennes

Rennes, France

Centre Hospitalier Rodez

Rodez, France

CHU Saint-Etienne

Saint-Etienne, France

Hôpital Privé de la Loire

Saint-Etienne, France

CHP Centre Saint Grégoire

Saint-Grégoire, France

Hôpital Instruction des Armées - BEGIN

Saint-Mandé, France

Clinique Sainte Anne - Strasbourg Oncologie Libérale

Strasbourg, France

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Hôpital FOCH

Suresnes, France

Centre Hospitalier Intercommunal de Toulon-La Seyne - Hôpital Ste Musse

Toulon, France

IUCT Oncopole

Toulouse, France

Clinique Pasteur ONCORAD

Toulouse, France

CHRU de Tours -Hôpital Bretonneau

Tours, France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Gustave Roussy Center

Villejuif, France

Universitätsmedizin Essen Hufelandstraße

Essen, Germany

St Vincent's University Hospital

Dublin, Ireland

Tallaght university Hospital

Dublin, Ireland

Mater Misericordiae University Hospital

Dublin, Ireland

Mater Private Hospital

Dublin, Ireland

University Hospital Limerick

Limerick, Ireland

University of Bari, Policlinico

Bari, Italy

FPO IRCCS Candiolo Turin

Candiolo, Italy

Azienda Ospedaliera Universitaria Policlinico Riuniti Di Foggia

Foggia, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

Meldola, Italy

Fondazione IRCSS Istituto Nazionale Tumori

Milan, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

istituto tumori Fondazione "G.Pascale"

Naples, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Istituto Clinico Humanitas - IRCCS

Rozzano, Italy

UOC Oncologia Medica

Syracuse, Italy

Santa Chiara Hospital

Trento, Italy

CHU de la Martinique - Hôpital Albert Clarac

Fort-de-France, Martinique

Albert Schweizer Hospital

Dordrecht, Netherlands

Radboudumc - Dutch Uro-Oncology Study Group (DUOS)

Nijmegen, Netherlands

Institutul Oncologic Prof Dr Al Trestioreanu Bucuresti

Bucharest, Romania

Amethyst Radiotherapy Center Cluj SRL

Cluj-Napoca, Romania

Institul Oncologic Cluj-Napoca

Cluj-Napoca, Romania

OncoHelp Hospital

Timișoara, Romania

Narodny Onkologicky Institut

Bratislava, Slovakia

Institut Catala d'Oncologia, Badalona-Hospital Germans Trias i Pujol

Badalona, Spain

Hospital Clinic

Barcelona, Spain

Hospital del Mar

Barcelona, Spain

Vall d'Hebron Institute of Oncology. Vall d'Hebron University Hospital

Barcelona, Spain

Institut Català d'Oncologia de Girona

Girona, Spain

Centro Integral Oncologico HM Clara Campal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Althaia, Xara Assistencial Universitaria Mansera

Manresa, Spain

Fundacion Instituto Valenciano De Oncologia

Valencia, Spain

Sahlgrenska University Hospital

Gothenburg, Sweden

Skane University Hospital

Malmö, Sweden

Istituto Oncologico della Svizzera Italiana (IOSI) - Ospedale S.Giovanni

Bellinzona, Switzerland

Kantonsspital Graubünden, Onkologie/ Hämatologie

Chur, Switzerland

Cantonal Hospital St.Gallen

Sankt Gallen, Switzerland

Istituto Oncologico della Svizzera Italiana (IOSI) - Ospedale Italiano di Lugano

Viganello, Switzerland

Universitätsspital Zürich - Onkologie

Zurich, Switzerland

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NCT04916613


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