Last updated on January 2019

A Phase III of ADT + Docetaxel +/- Local RT +/- Abiraterone Acetate in Metastatic Hormone-na ve Prostate Cancer


Brief description of study

This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy (+ docetaxel) with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-nave prostate cancer.

Detailed Study Description

Eligible patients can be randomize in the trial after his consent form has been signed, and after all inclusion and non-inclusion criteria have been checked.

The randomisation will result in the allocation of arm A (ADT +docetaxel), arm B (ADT +docetaxel +Abiraterone), arm C (ADT +docetaxel +radiotherapy) or arm D (ADT +docetaxel +Abiraterone +radiotherapy) in a 1:1:1:1 ratio.

The randomization will be stratified (by minimization) according to:

  • enrolment center,
  • performance status (0 vs. 1-2)
  • disease extent: lymph nodes only vs. bone (with or without lymph nodes) vs. presence of visceral metastases.

CRPC is defined by cancer progression (either a confirmed PSA rise or a radiological progression) with serum testosterone being at castrated levels (<0.50 ng/mL).

When the CRPC stage is reached, castration (either LHRH agonist or LHRH antagonist) will be maintained in all patients.

Investigators will be free to manage patients reaching CRPC at their discretion (using for example docetaxel, zoledronic acid, denosumab, sipuleucel-T, radium-223, cabazitaxel, etc) according to local uses and guidelines.

Abiraterone may be used in arm A and C if abiraterone has become the standard treatment for CRPC when this stage is reached.

Clinical Study Identifier: NCT01957436

Contact Investigators or Research Sites near you

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Hopital de Jolimont

Haine Saint Paul, Belgium

Institut de cancerologie de l'Ouest

ANGERS Cedex 9, France

Institut Sainte Catherine

Avignon Cedex 9, France

Chu Jean Minjoz

Besancon, France

Institut Bergonie

Bordeaux, France

Clinique Pasteur

Brest, France

Centre Hospitalier Alpes Leman

Contamine Sur Arve, France

SERA

Contamine Sur Arve, France

Chu de Mondor

Creteil, France

CHD Vend e

La ROCHE sur YON, France

Clinique Victor Hugo

Le Mans, France

Chu de Limoges

Limoges, France

Centre L on B rard

Lyon cedex 08, France

Chu Timone

MARSEILLE Cedex 5, France

Institut Paoli Calmettes

Marseille, France

Centre Catherine de Sienne

Nantes Cedex 2, France

CHU Car meau

NIMES Cedex 9, France

CHR Orl ans la source

Orleans, France

Institut Curie

Paris, France

H pital St Louis

Paris, France

Chic Quimper

Quimper, France

Centre Eug ne Marquis

RENNES Cedex, France

Chu de Rouen

Rouen, France

Clinique Armoricaine de radiologie

Saint Brieuc, France

CHU ST ETIENNE - H pital Nord

Saint Etienne, France

CHP Saint Gr goire

Saint Gregoire, France

Institut de Canc rologie Lucien Neuwirth

St PRIEST EN JAREZ, France

Strasbourg Oncologie Lib rale

Strasbourg, France

Hopitaux du Leman

Thonon-les-bains, France

Clinique Pasteur

TOULOUSE Cedex 3, France

Institut Claudius Regaud

TOULOUSE Cedex, France

Cork University Hospital

Cork, Ireland

Mater Private Hospital

Dublin, Ireland

Galway University Hospital

Galway, Ireland

Hospital del Mar

Barcelona, Spain

Hospital 12 OCTUBRE

Madrid, Spain

Althaia

Manresa, Spain

Clinique de L'Europe

Amiens, France

Centre Marie Curie

Arras, France

Centre de la Baie

Avranches, France

Centre Pierre Curie

Beuvry, France

Centre Leonard de Vinci

Dechy, France

CHU Lyon Sud

Lyon, France

H pital Nord

Marseille, France

Hopital TENON

Paris, France

Universit ts-klinikum Freiburg

Freiburg, Germany

Gesundheitszentrum Holzminden

Holzminden, Germany

'Hospital Bestriz angelo

Loures, Portugal

Clinique Sainte Marguerite

Hyères, France

Recruitment Status: Closed


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