drugset / Trial / NCT00705822

Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer

NCT00705822

Phase 3 Terminated 54 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

To compare the efficacy of both strategies (reference treatment: Docetaxel+Prednisone and experimental treatment: Docetaxel+Estramustine+Hydrocortisone) by means of PSA values. To determine the time to treatment failure in both strategies To determine the overall and specific cause survival To evaluate the safety profile To analyze the Quality of Life

Timeline

Start
2006-08
Primary completion
2009-07
Completion
2009-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrocortisone Other / unclassified 20 mg Oral
Comparator Prednisone Other / unclassified 5 mg Oral
Subject estramustine Other / unclassified 140 mg Oral
Background Docetaxel Small molecule 80 mg Intravenous

Indications