Radical prostatectomy versus expectant primary treatment in stages I and II prostatic cancer. A fifteen-year follow-up.

A fifteen-year follow-up of a prospective, randomized study comparing placebo with radical prostatectomy as the primary treatment of early prostatic cancer is presented. A total of 111 patients with clinical Stage I or II prostatic cancer, normal acid phosphatase levels, and negative findings on skeletal x-ray film were evaluable. Thirty Stage I patients and 20 Stage II patients received placebo only; 31 Stage I and 30 Stage II patients underwent radical prostatectomy. The survival status for 95 patients (86%) was established at the fifteen-year follow-up. No significant differences in crude survival occurred in either stage or in both stages combined. Moreover, the survival curves closely followed reference curves based on expected U.S. mortality for men of comparable ages and races. A statistically significant association between a high Gleason histologic score and poor survival was established. In this study, initial treatment with radical prostatectomy did not yield longer survival than initial placebo treatment alone. However, the findings should be interpreted with caution, since sample size was small and staging procedure was simplified.

RCT Entities:   Population Interventions Outcomes