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 pat hologic stage and biochemical recurrence rates. Methods. One hundred fifty-six men with clinically localized prostate cance r 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 s tage T3a versus organ-confined disease (25% versus 4%, P < 0.05), pretreatm ent 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 wi th PSA levels lower than 10 mu g/L (15% versus 0%, P < 0.01). Overall PSA r ecurrence 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% or gan confined, P < 0.01), pretreatment PSA (7% if PSA lower than 10 mu g/L v ersus 21% if 10 mu g/L or higher, P < 0.02), Gleason score (9% if 6 or lowe r 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 i s low after 5 years of follow-up and remains proportional to the presence o f adverse preoperative risk factors. Prospective randomized studies are req uired to determine whether longer duration of neoadjuvant therapy reduces t he risk of biochemical recurrence after radical prostatectomy. UROLOGY 56: 289-294, 2000. (C) 2000, Elsevier Science Inc.