Long-term neoadjuvant hormone therapy prior to radical prostatectomy: evaluation of risk for biochemical recurrence at 5-year follow-up

Objectives. To assess the effects of 8 months of neoadjuvant therapy on pathologic stage and biochemical recurrence rates. Methods. One hundred fifty-six men with clinically localized prostate cancer were treated with neoadjuvant combined androgen withdrawal therapy for 8 months prior to radical prostatectomy. Preoperative clinical stage, Gleason score, and serum prostate-specific antigen (PSA) levels were compared with treatment outcome (pathologic stage and PSA recurrence). Results. PSA at diagnosis was 10 mu g/L or higher in 36% with a mean of 11.5 mu g/L. Clinical stage was T1c in 18%, T2 in 74%, and T3a in 8%. Gleason score was 6 or lower in 76% and 7 or higher in 24%. Pathologic stage was T0 in 13%, T2 in 66%, T3 (specimen confined) in 13%, T3 (margin positive) in 6%, and TxN+ in 2%. Incidence of positive margins increased with clinical stage T3a versus organ-confined disease (25% versus 4%, P < 0.05), pretreatment Gleason scores 7 or higher versus Gleason scores 6 or lower (11% versus 4%, P = NS), and pretreatment PSA levels higher than 10 mu g/L compared with PSA levels lower than 10 mu g/L (15% versus 0%, P < 0.01). Overall PSA recurrence rate was 12.2% after a mean postoperative follow-up of 54 months. Risk of PSA recurrence increased with clinical stage (25% T3 versus 11% organ confined, P < 0.01), pretreatment PSA (7% if PSA lower than 10 mu g/L versus 21% if 10 mu g/L or higher, P < 0.02), Gleason score (9% if 6 or lower versus 22% if 7 or higher, P < 0.02), and pathologic stage (6% of pT2, 24% of pT3M-, and 56% of pT3M+, P < 0.01). PSA recurrences occurred in 6% of patients with no adverse preoperative risk factors, 12% with any one of the high-risk factors, and 29% with any two of the high-risk factors. Conclusions. Risk of PSA recurrence after 8 months of neoadjuvant therapy is low after 5 years of follow-up and remains proportional to the presence of adverse preoperative risk factors. Prospective randomized studies are required to determine whether longer duration of neoadjuvant therapy reduces the risk of biochemical recurrence after radical prostatectomy. UROLOGY 56: 289-294, 2000. (C) 2000, Elsevier Science Inc.