The final analysis of the EORTC Genito-Urinary Tract 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

Eur Urol. 1995;28(4):273-83.

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adenocarcinoma / mortality
  • Adenocarcinoma / secondary*
  • Adenocarcinoma / therapy
  • Aged
  • Androgen Antagonists / therapeutic use*
  • Antineoplastic Agents, Hormonal / adverse effects
  • Antineoplastic Agents, Hormonal / therapeutic use*
  • Combined Modality Therapy
  • Cyproterone Acetate / adverse effects
  • Cyproterone Acetate / therapeutic use*
  • Diethylstilbestrol / adverse effects
  • Diethylstilbestrol / therapeutic use*
  • Humans
  • Male
  • Orchiectomy* / adverse effects
  • Prostatic Neoplasms / mortality
  • Prostatic Neoplasms / pathology*
  • Survival Rate
  • Time Factors

Substances

  • Androgen Antagonists
  • Antineoplastic Agents, Hormonal
  • Cyproterone Acetate
  • Diethylstilbestrol