A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,173

Participants

Timeline

Start Date

November 13, 2013

Primary Completion Date

August 18, 2021

Study Completion Date

December 31, 2032

Conditions
Metastatic Prostate Cancer
Interventions
DRUG

abiraterone acetate

abiraterone 1000mg/day (4 tablets of 250 mg (PO) per day) + prednisone 5mg bid

RADIATION

radiotherapy

74 Gy in 37 fractions 3D-Conformal RT or Intensity Modulated RT (IMRT)

OTHER

Androgen Deprivation Therapy

The ADT must consist in either LHRH agonist, LHRH antagonist or orchiectomy

DRUG

Docetaxel

6 cycles at 75mg/m²/cycle, one cycle every 3 weeks

Trial Locations (77)

13273

Institut Paoli Calmettes, Marseille

13385

Chu Timone, Marseille

21079

Centre Georges-François LECLERC, Dijon

22015

Clinique Armoricaine de radiologie, Saint-Brieuc

25030

Chu Jean Minjoz, Besançon

29107

Chic Quimper, Quimper

30029

CHU Carémeau, Nîmes

31052

Institut Claudius Regaud, Toulouse

31076

Clinique Pasteur, Toulouse

33076

Institut Bergonie, Bordeaux

35042

Centre Eugène Marquis, Rennes

35760

CHP Saint Grégoire, Saint-Grégoire

42271

Institut de Cancérologie Lucien Neuwirth, Saint-Priest-en-Jarez

44202

Centre Catherine de Sienne, Nantes

44270

CHU ST ETIENNE - Hôpital Nord, Saint-Etienne

44805

Institut de Cancérologie del'Ouest - site René Gauducheau, Saint-Herblain

45100

CHR Orléans la source, Orléans

49933

Institut de cancerologie de l'Ouest, Angers

64100

Centre d'Oncologie et de Radiothérapie du Pays Basque, Bayonne

67000

Strasbourg Oncologie Libérale, Strasbourg

69373

Centre Léon Bérard, Lyon

72000

Clinique Victor Hugo, Le Mans

74000

Clinique Générale d'Annecy, Annecy

74130

Centre Hospitalier Alpes Leman, Contamine-sur-Arve

74203

Hopitaux du Leman, Thonon-les-Bains

75005

Institut Curie, Paris

75010

Hôpital St Louis, Paris

81000

Clinique Claude Bernard, Albi

83056

Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer - Hôpital Sainte Musse, Toulon

83400

Clinique Sainte Marguerite, Hyères

84918

Institut Sainte Catherine, Avignon

85925

CHD Vendée, La Roche-sur-Yon

87042

Chu de Limoges, Limoges

94010

Chu de Mondor, Créteil

94805

INSTITUT GUSTAVE ROUSSY, Cancer Campus, Grand Paris, Villejuif

Unknown

Onze Lieve Vrouw Ziekenhuis, Aalst

Hôpitaux Universitaires Bordet Erasme- Institut Jules Bordet, Brussels

Hopital de Jolimont, Haine-Saint-Paul

AZ Groeninge Kortrijk - Campus Vercruysselaan, Kortrijk

Cliniques Universitaires Saint-Luc, Leuven

U.Z. Leuven - Campus Gasthuisberg, Leuven

Centre de la Baie, Avranches

Centre Pierre Curie, Beuvry

Centre François Baclesse, Caen

Centre Leonard de Vinci, Dechy

CHU Lyon Sud, Lyon

Hôpital Nord, Marseille

Hopital TENON, Paris

Institut Jean Godinot, Reims

CENTRE DE CANCEROLOGIE Paris Nord, Sarcelles

CHU de TOURS Hôpital Bretonneau, Tours

Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy

Centre d'Oncologie Saint Yves, Vannes

Cork University Hospital, Cork

Adelaide and Meath incorporating National Children's hospital department, Dublin

Mater Misericordiae University Hospital, Dublin

Mater Private Hospital, Dublin

St Vincent's University Hospital, Dublin

Galway University Hospital, Galway

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

San Camillo Forlanini Hospitals, Roma

Sc Radiotherapy Center Cluj SRL, Cluj-Napoca

Hospital Germans Trias i Pujol, Badalona

Hospital De la Santa Creu I Sant Pau, Barcelona

Hospital del Mar, Barcelona

Vall d'Hebron University Hospital, Barcelona

ICO Girona - Hospital Josep Trueta, Girona

Hospital Universitario HM Sanchinarro, Madrid

Althaia, Manresa

'Hospital Clinico Virgen de la Victoria, Málaga

'Parc Tauli Sabadell Hospital Universitari, Sabadell

Hospital Universitario de Salamanca, Salamanca

Institut Valenciano de Oncologia, Valencia

Fondation Dr. Henri Dubois-Ferrière Dinu Lipatti, Geneva

Centre Hospitalier Universitaire Vaudois, Lausanne

06250

Centre Azuréen de Cancérologie, Mougins

06189

Centre Antoine Lacassagne, Nice

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Janssen-Cilag Ltd.

INDUSTRY

collaborator

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

collaborator

Ipsen

INDUSTRY

collaborator

Sanofi

INDUSTRY

lead

UNICANCER

OTHER

NCT01957436 - A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer | Biotech Hunter | Biotech Hunter