Phase II, randomized, multicentric study of docetaxel and zoledronic acid versus zoledronic acid in patient with prostate cancer and bone metastase treated with LHRH

INTERVENTION: Pharmaceutical Form: Solution for infusion INN or Proposed INN: Docetaxel Concentration type: equal Trade Name: ZOMETA Pharmaceutical Form: Powder for infusion* INN or Proposed INN: Zoledronic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4‐ CONDITION: Advanced prostate cancer ; MedDRA version: 9.1 Level: HLT Classification code 10036966 Term: Prostatic neoplasms and hypertrophy PRIMARY OUTCOME: Main Objective: Progression free survival Primary end point(s): Progression free survival Secondary Objective: Survival, Tollerability, adverse event, quality of life, pain, scheletal related event, biological endpoint INCLUSION CRITERIA: ‐ Prostate adenocarcinoma ‐Metastatic disease "ab initio" or neoplasic disease after loco‐regional therapy ‐Bone metastase ‐Age > 18 ‐ECOG P.S=65 years) yes F.1.3.1 Number of subjects for this age range