The Final Analysis of the EORTC Genito-Urinary T ract Cancer Co-Operative Group Phase III Clinical Trial (Protocol 30805) Comparing Orchidectomy, Orchidectomy plus Cyproterone Acetate and Low Dose Stilboestrol in the Management of Metastatic Carcinoma of the Prostate

Abstract

This report is the final analysis of an EORTC Genito-Urinary Group Phase III trial (Protocol 30805) comparing orchidectomy, orchidectomy plus cyproterone acetate 50 mg 3 times a day and stilboestrol 1 mg daily in the management of metastatic carcinoma of the prostate. Three hundred and twenty-eight eligible patients admitted into the study have been followed up for a median period of 4 years. There was no difference in time to metastatic progression and overall survival between the treatment arms. The cardiovascular toxicity of stilboestrol 1 mg daily has resulted in more cardiovascular deaths as compared with the orchidectomy treatment arm. The outcome for individual patients has been determined by on-study prognostic factors, especially the performance status, rather than the treatment given.