Effect of complete androgen blockade on pathologic stage and resection margin status of prostate cancer: Progress pathology report of the Italian PROSIT study

Objectives. To compare the pathologic stage and surgical margin status in p atients undergoing either immediate radical prostatectomy or surgery preced ed by 3 or 6 months of neoadjuvant hormonal treatment (NHT) in a prospectiv e, randomized study. Methods. Four hundred thirty-one men with prostate cancer were enrolled in the Italian randomized prospective PROSIT study. The whole-mount sectioning technique was used. By May 1999, the reviewing pathologist had evaluated 3 03 specimens. One hundred seven patients were untreated before radical pros tatectomy was performed, and 114 and 82 patients had been treated for 3 and 6 months, respectively, with complete androgen blockade. Results. Pathologic organ-confined disease was found in 63.1% of patients w ith clinical Stage B disease treated with 6 months of NHT versus 61.0% afte r 3 months of NHT and 37.5% after immediate surgery. Among patients with cl inical Stage C tumors, pathologic staging found organ-confined disease in 6 2.5%, 32.1%, and 11.1% of patients after 6 months of NHT, 3 months of NHT, and immediate surgery, respectively. Three months of NHT produced a signifi cant increase in negative margins both in patients with clinical Stage B an d C disease, but the addition of another 3 months of treatment did not sign ificantly improve this result. A lower degree of benefit was observed in pa tients with clinical Stage C tumors. Conclusions. This study shows that complete androgen blockade before surger y is beneficial in men with clinical Stage B disease. The effects are more pronounced after 6 months of NHT than after 3 UROLOGY 57: 117-121, 2001. (C ) 2001, Elsevier Science Inc.