CUOG randomized trial of neoadjuvant androgen ablation before radical prostatectomy: 36-month post-treatment PSA results

Objectives. To test the hypothesis that neoadjuvant androgen ablation befor e radical prostatectomy reduces the likelihood of biochemical progression a t 36 months. Methods. Two hundred thirteen patients with localized prostate cancer were randomized to radical prostatectomy alone (Sx, n = 101) or a 12-week course of 300 mg of cyproterone acetate daily followed by surgery (CPA, n = 112). Biochemical progression (two consecutive detectable prostate-specific anti gen [PSA] values) was determined for the entire group and by baseline PSA, Gleason score, clinical stage, and pathologic stage. Results. The probability of biochemical progression at 36 months was simila r in both groups (CPA 40.2%, Sr 30.1%; P = 0.3233). CPA patients with basel ine serum PSA between 25 and 50 ng/mL had a lower probability of biochemica l progression (CPA 63.5%, Sr 84.6%; P = 0.0038). No difference in the proba bility of biochemical progression was seen between groups when analyzed by clinical stage or Gleason score. When analyzed by pathologic margin status, no difference was observed in the probability of biochemical progression i n patients with organ-confined disease (P = 0.4484). There was a trend for a higher probability of progression in the neoadjuvant arm in patients with positive and negative surgical margins (P = 0.0105, P = 0.0459; alpha = 0. 005 with Bonferroni adjustment). Conclusions. Neoadjuvant androgen ablation with CPA reduces the positive ma rgin rate significantly but does not result in a difference in biochemical progression at 3 years. This may be due to a lack of sufficient follow-up, insufficient power of the trial to demonstrate a small benefit, or a true l ack of benefit of neoadjuvant androgen ablation before radical prostatectom y. (C) 1999, Elsevier Science Inc. All rights reserved.