Titre A Prospective, Multicenter, Randomized, Double Blind, Placebo-controlled, 2-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With Docetaxel to Placebo in Combination With Docetaxel in First Line Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Protocole ID AB12003
ClinicalTrials.gov ID NCT03761225
Type(s) de cancer Prostate
Phase Phase III
Stade Métastatique
Type étude Traitement
Médicament masitinib
Institution CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE
   HOPITAL FLEURIMONT
      3001 12e Avenue Nord, Sherbrooke, QC, J1H 5N4
Ville Sherbrooke
Investigateur(trice) principal(e) Dr Michel Pavic
Coordonnateur(trice) Anick Champoux
 819-346-1110 poste 12811
Statut Fermé
Critètes d'éligibilité
  • Histologically or cytologically confirmed metastatic Castrate Resistant Prostate Cancer (medical or surgical castration: androgens deprivation by GnHR agonist or antagonist or patient with surgical castration; hormonal castration confirmed biologically (testosterone < 0.5ng/ml) with one of the following criteria:
  • Pre-treated with abiraterone with documented progressive disease, OR
  • Indicated for initiating docetaxel treatment (e.g., widespread visceral disease or rapidly progressive disease).
  • Patient with evidence of progressive metastatic disease as assessed according to the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) recommendations.
  • Patient with adequate organ function as per protocol
Critètes d'exclusion
  • Patient who has been previously treated with chemotherapy.