Multidisciplinar, multicenter, randomized phase III clinical trial comparing taxotere plus estramustine phosphate plus prednisone, versus taxotere prednisone, in advanced prostate carcinoma patients with biochemical relapse during androgen ablation.

INTERVENTION: Trade Name: Taxotere Product Name: Taxotere Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Docetaxel Current Sponsor code: XRP6976J Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80‐ Product Name: Prednisone Pharmaceutical Form: Tablet INN or Proposed INN: Prednisone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Trade Name: Estracyt oral Product Name: Estracyt oral Pharmaceutical Form: Capsule* INN or Proposed INN: Estramustina Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 140‐ Trade Name: Hidrocortisone Product Name: Hidrocortisone Pharmaceutical Form: Tablet INN or Proposed INN: Hidrocortisone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ CONDITION: Acvanced prostate carcinoma PRIMARY OUTCOME: Main Objective: PSA response rates (PSAWG criteria) Primary end point(s): PSA response rates (PSAWG criteria Secondary Objective: ‐ Time to Treatment Failure; ‐ Progression Free Survival (either biochemical or clinical); ‐ Overall and Cause Specific Survival; ‐ Clinical response rates (RECIST); ‐ Safety. Toxicity profile according to NCIC‐CTG Criteria; ‐ Quality of Life (EORTC QLC‐30Q+ prostate questionnaire) INCLUSION CRITERIA: ‐ Histologically confirmed prostate adenocarcinoma ‐ Confirmed prostate adenocarcinoma in biochemistry progression androgens block and demonstrated progression despite cessation of antiandrogen therapy. ‐ Patients must have received prior hormonal therapy. ‐ Castration levels of testosterone (Minor to 50 ng/dL) ‐ Biochemistry relapse. ‐ Adequate bone marrow, Hepatic and Renal function. ‐ Patients must be accessible for treatment and follow‐up. ‐ Prior surgery and/or radiation therapy is allowed if at least 4 weeks have elapsed since the completion of radiation therapy and the patient have recovered from side effects. Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range