Neoadjuvant hormone therapy before radical prostatectomy: Update on Phase II and III Memorial Sloan-Kettering Cancer Center trials

At Memorial Sloan-Kettering Cancer Center, Phase II and III trials have bee n conducted evaluating pathologic results and relapse-free survival as judg ed by prostate specific antigen (PSA) in patients with localized prostate c ancer undergoing radical prostatectomy with or without neoadjuvant hormone therapy (NHT), Pelvic lymphadenectomy, radical prostatectomy, or both with or without NHT was performed in 141 patients enrolled in the Phase LI trial and 140 patients in the Phase III trial. In the Phase II study, 35 (49%) o f the 72 patients in the control group had organ-confined margin-negative d isease compared with 48 (70%) of the 69 patients in the NHT arm (P = 0.0057 ; chi(2) test). With a median follow-up of 57 months, there was no signific ant difference in PSA relapse rates between the two arms (P = 0.43; log-ran k test). In the Phase III study, 39 (59%) of the 66 patients in the control arm had organ-confined margin-negative disease compared with 52 (70%) of t he 74 patients in the NHT arm (P = 0.17; chi(2) test). However, the positiv e-margin rate was significantly lower in the NHT arm (19%) than in the cont rol arm (37%) (P = 0.023; chi(2) test). With a median follow-up of 24 month s, there was no significant difference in the PSA relapse rates in the two arms (P = 0.60; log-rank test). Although these results suggest that NHT imp roves the pathologic results, further followup is necessary to determine if this change will translate into improved disease-free survival.