Abstract

The Veterans Administration Cooperative Urological Research Group is engaged currently in a prospective study of carcinoma of the prostate. This is the first report of the progress of the study since its initiation. There are four stages of this disease. However, this report deals almost exclusively with Stage III and Stage IV patients, i.e. patients with advanced disease. There are four treatments (orchiectomy + estrogen, orchiectomy alone, estrogen alone, and placebo alone) to which the patients are randomly assigned. Patients are allocated to either estrogen or placebo so that neither patient nor clinician is aware of what drug the patient receives. Preliminary results show that patients receiving orchiectomy + estrogen, orchiectomy alone, or estrogen alone exhibit a better over-all response than do those patients receiving placebo alone. This pattern persists up to and including the 18-month follow-up examination. There appears to be excellent correlation between General Clinical Impression— the clinician's subjective appraisal of the patient—and Over-all Response—the objective appraisal of the patient—for all stages and treatment groups at all three follow-up examinations with the exception that clinical appraisal seems to be some-what over-optimistic in that only approximately 40 per cent of the patients with increasing disease (the objective measure of response) are judged to be clinically worse.

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