Neoadjuvant hormone therapy before surgery for prostate cancer: The Italian Experience (PROSIT Study)

Despite the growing use in clinical practice of neoadjuvant hormone therapy (NHT) for patients with clinically localized prostate cancer eligible for radical retropubic prostatectomy (RRP), to our knowledge, no randomized tri al has addressed the issue of NHT for 6 months compared with 3 months and a control arm. It seems worthwhile to determine NHT efficacy in a randomized multicenter trial, testing the efficacy of total androgen blockade (TAB) f or 3 or 6 months in patients with clinically localized prostate cancer (Sta ge B [AUS/T2N0M0; UICC 1992] or State C [T3N0M0] eligible for radical retro pubic prostatectomy (RRP), The study aim is to determine if NHT modifies tu mor grade and stage at pathologic evaluation after RRP, time to PSA progres sion, time to clinical progression, and specific and overall survival. The PROSIT Study is a prospective open, multicenter Phase III study in which pa tients with clinical stage B or C prostate cancer are randomized to one of the following arms of preoperative treatment: none, goserelin depot 3.6 eve ry 28 days + bicalutamide 50 mg/day for 3 months, or goserelin depot 3.6 ev ery 28 days + bicalutamide 50 mg/day for 6 months. As of December 31, 1997, 238 patients had been enrolled, and following the randomization process, 8 2 patients were included in the immediate-surgery arm (Surgery), 77 in the 12-week NHT arm (12 NHT), and 79 in the 24-week NHT arm (24 NHT). In both o f the NHT treatment arms, there was a trend to a reduction of clinical unde rstaging in clinical Stage B tumors and an increase of clinical overstaging in clinical Stage C tumors. When primary Gleason grade was compared with t he final grade in the treated tumors, there was an apparent higher grade in the surgical than the biopsy specimens. Preliminary results show a better effect of NHT on Stage B tumors.