Neoadjuvant Hormone Therapy Before Radical Prostatectomy: Update on the Memorial Sloan-Kettering Cancer Center Trials

We report here the latest follow-up of the Phase II and III trials evaluating pathologic results and relapse-free survival, as judged by serum prostate specific antigen (PSA), in patients with localized prostate cancer who had radical prostatectomy performed at the Memorial Sloan-Kettering Center (MSKCC) either with or without neoadjuvant hormone therapy (NHT). Pelvic lymphadenectomy (PLND), radical prostatectomy, or both with or without NHT was performed in 141 patients enrolled in a Phase II trial comparing patients receiving NHT with concurrent controls and 140 patients in a randomized Phase III trial. In the Phase II study, there was a significant difference in the pathologic results, with only 35 (49%) of the 72 patients in the control group having organ-confined margin-negative disease 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 significant difference in the PSA relapse rates in the two arms (P = 0.92; log-rank 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 the 74 patients in the NHT arm (P = 0.17; chi(2) test). However, the positive-margin rate was significantly lower in the NHT arm (19%) than in the control arm (37%) (P = 0.023; chi(2) test). With a median follow-up of 35 months, there was no significant difference in the PSA relapse rates in the two arms (P = 0.73; log-rank test). Thus, although NHT improves the pathologic results, further follow-up is necessary to determine if this marked reduction in the positive-margin rate will translate into improved disease-free survival.