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

PHASE3RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

April 19, 2022

Primary Completion Date

March 31, 2028

Study Completion Date

September 30, 2037

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

Trial Locations (90)

1340

RECRUITING

Clinique Saint Pierre, Ottignies

5000

RECRUITING

CHU UCL NAMUR - Site STE. ELISABETH, Namur

6000

RECRUITING

Grand Hopital de Charleroi - site Notre Dame, Charleroi

6500

RECRUITING

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

7100

RECRUITING

Groupe Jolimont - Hôpital De Jolimont, Haine-Saint-Paul

12027

RECRUITING

Centre Hospitalier Rodez, Rodez

13273

RECRUITING

Institut Paoli-Calmettes, Marseille

14076

RECRUITING

Centre François Baclesse, Caen

20089

RECRUITING

Istituto Clinico Humanitas - IRCCS, Rozzano

20133

NOT_YET_RECRUITING

Fondazione IRCSS Istituto Nazionale Tumori, Milan

20251

NOT_YET_RECRUITING

University cancer center Hamburg-Eppendorf Martinistraße, Hamburg

21079

RECRUITING

Centre Georges François Leclerc, Dijon

22076

RECRUITING

Centre Institut Bergonié, Bordeaux

25000

RECRUITING

CHU Besançon - Hopital Jean Mijoz, Besançon

29107

RECRUITING

CHIC Quimper, Quimper

29200

RECRUITING

Clinique Pasteur, Brest

30029

RECRUITING

CHU Nîmes, Nîmes

31059

RECRUITING

IUCT Oncopole, Toulouse

31076

RECRUITING

Clinique Pasteur ONCORAD, Toulouse

35042

RECRUITING

Centre Eugène Marquis, Rennes

35760

RECRUITING

CHP Centre Saint Grégoire, Saint-Grégoire

37044

RECRUITING

CHRU de Tours -Hôpital Bretonneau, Tours

38043

RECRUITING

CHU Grenoble, Grenoble

38122

RECRUITING

Santa Chiara Hospital, Trento

42055

RECRUITING

CHU Saint-Etienne, Saint-Etienne

42100

RECRUITING

Hôpital Privé de la Loire, Saint-Etienne

47014

RECRUITING

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

48149

NOT_YET_RECRUITING

Universitätsklinikum Münster Klinik für Urologie und Kinderurologie Albert-Schweitzer-Campus 1 Gebäude A1, Münster

51056

RECRUITING

Institut Jean Godinot, Reims

54500

RECRUITING

Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy

56322

RECRUITING

Groupe Hospitalier Bretagne Sud, Lorient

59000

RECRUITING

Centre Oscar Lambret, Lille

63011

RECRUITING

Centre Jean Perrin, Clermont-Ferrand

64109

RECRUITING

Centre Hospitalier Cote basque, Bayonne

67000

RECRUITING

Clinique Sainte Anne - Strasbourg Oncologie Libérale, Strasbourg

67200

RECRUITING

Institut de cancérologie Strasbourg Europe, Strasbourg

69310

RECRUITING

Hospices Civils de Lyon -Lyon Sud, Pierre-Bénite

69373

RECRUITING

Centre Léon Bérard, Lyon

70124

NOT_YET_RECRUITING

University of Bari, Policlinico, Bari

72000

RECRUITING

CHU le MANS, Le Mans

73000

RECRUITING

Centre Hospitalier Métropole Savoie, Chambéry

74374

RECRUITING

CH Annecy Genevois, Pringy

75020

RECRUITING

Centre Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris

75475

RECRUITING

Hôpital Saint Louis, Paris

75908

RECRUITING

Hôpital Européen Georges Pompidou, Paris

75970

RECRUITING

Hôpital Tenon, Paris

80131

NOT_YET_RECRUITING

"istituto tumori Fondazione G.Pascale", Napoli

83056

RECRUITING

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

84918

RECRUITING

Institut Sainte Catherine, Avignon

85925

RECRUITING

Centre CHV Vendée, La Roche-sur-Yon

86021

RECRUITING

CHU de Poitiers - Pôle Régional de Cancérologie, Poitiers

87000

RECRUITING

Polyclinique de Limoges, Limoges

92151

RECRUITING

Hôpital FOCH, Suresnes

94010

RECRUITING

APHP - Hôpital Henri Mondor, Créteil

94160

RECRUITING

Hôpital Instruction des Armées - BEGIN, Saint-Mandé

94805

RECRUITING

Gustave Roussy Center, Villejuif

96100

NOT_YET_RECRUITING

UOC Oncologia Medica, Syracuse

97200

NOT_YET_RECRUITING

CHU de la Martinique - Hôpital Albert Clarac, Fort-de-France

06250

RECRUITING

Centre Azuréen de Cancérologie, Mougins

06189

RECRUITING

Centre Antoine Lacassagne, Nice

Unknown

NOT_YET_RECRUITING

Universitätsmedizin Essen Hufelandstraße, Essen

RECRUITING

Mater Misericordiae University Hospital, Dublin

RECRUITING

Mater Private Hospital, Dublin

NOT_YET_RECRUITING

FPO IRCCS Candiolo Turin, Candiolo

NOT_YET_RECRUITING

Albert Schweizer Hospital, Dordrecht

RECRUITING

Radboudumc - Dutch Uro-Oncology Study Group (DUOS), Nijmegen

NOT_YET_RECRUITING

Institutul Oncologic Prof Dr Al Trestioreanu Bucuresti, Bucharest

NOT_YET_RECRUITING

Amethyst Radiotherapy Center Cluj SRL, Cluj-Napoca

RECRUITING

Institul Oncologic Cluj-Napoca, Cluj-Napoca

RECRUITING

OncoHelp Hospital, Timișoara

NOT_YET_RECRUITING

Narodny Onkologicky Institut, Bratislava

RECRUITING

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

RECRUITING

Hospital Clinic, Barcelona

RECRUITING

Hospital del Mar, Barcelona

RECRUITING

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

RECRUITING

Institut Català d'Oncologia de Girona, Girona

RECRUITING

Centro Integral Oncologico HM Clara Campal, Madrid

NOT_YET_RECRUITING

Hospital Universitario 12 de Octubre, Madrid

RECRUITING

Althaia, Xara Assistencial Universitaria Mansera, Manresa

RECRUITING

Fundacion Instituto Valenciano De Oncologia, Valencia

NOT_YET_RECRUITING

Sahlgrenska University Hospital, Gothenburg

NOT_YET_RECRUITING

Skane University Hospital, Malmo

RECRUITING

Kantonsspital Graubünden, Onkologie/ Hämatologie, Chur

RECRUITING

Cantonal Hospital St.Gallen, Sankt Gallen

RECRUITING

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

RECRUITING

Universitätsspital Zürich - Onkologie, Zurich

D04 T6F4

RECRUITING

St Vincent's University Hospital, Dublin

D24 NR0A

RECRUITING

Tallaght university Hospital, Dublin

00152

NOT_YET_RECRUITING

Azienda Ospedaliera S. Camillo-Forlanini, Roma

00168

NOT_YET_RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

UNICANCER

OTHER