Neoadjuvant androgen ablation for localized prostatic cancer: pathology methods, surgical end points and meta-analysis of randomized trials.

ABSTRACT

PURPOSE: At least 7 centers or collaborative groups have performed randomized clinical trials of neoadjuvant androgen ablation and radical prostatectomy versus radical prostatectomy alone for localized prostatic cancer. Our objectives were to analyze treatment results in terms of 2 standard outcome measures, to identify patient characteristics and other factors that explain outcome differences between trials, and to use pooled data to test the hypothesis that neoadjuvant treatment alters outcomes. MATERIALS AND METHODS: Trials were identified by MEDLINE search and review of published bibliographies, and examined for pathological techniques used to assign surgical end points. An attempt was made to contact trial group members for clarification and updated information. The resulting data were transformed as needed into standardized end points of pT stage and negative surgical margin. A series of contingency tables were used to study relationships between treatment outcomes and various risk factors. RESULTS: In addition to neoadjuvant treatment, numerous risk factors related to treatment regimen and patient characteristics apparently influenced treatment outcome, and should be reanalyzed when future followup trial data become available. CONCLUSIONS: In radical prostatectomy there is a need for uniform ways to process specimens, assign surgical stage and establish standardized surgical end points. Despite differences in risk factors, the trials were similar in overall design. Within these constraints neoadjuvant androgen ablation was significantly associated with low pT stage and negative surgical margin. Longer followup is needed to validate these measures as good surrogates for tumor specific survival.