Randomized Comparative Study of 3 vs 8 Months of Neoadjuvant Hormonal Therapy Prior to Radical Prostatectomy

Neoadjuvant hormonal therapy prior to radical prostatectomy: promises and pitfalls

“…CUOG-P95A randomized 547 men with clinically con®ned prostate cancer to either 3 or 8 months of leuprolide acetate and¯utamide prior to radical prostatectomy. 47 The study was powered to detect a 25% decrease in PSA recurrence, assuming a 30% recurrence in the 3 month arm after 3 y. Patients were equally strati®ed for clinical stage, Gleason grade and serum PSA.…”

Role of radical prostatectomy in the treatment of high-risk prostate cancer

“…Gleave et al [ 37 ] addressed the question of duration of NADT by randomly allocating 549 men to receive 3 versus 8 months of therapy. Again, margin-positive rates declined from 23% to 12% (P = 0.01), but no difference in biochemical-free survival at 3 years was observed between the two groups [ 38 ]. Although the study by Klotz et al [ 34 ] provides preliminary evidence suggesting that high-risk patients may benefi t from a short course of NADT before RP, its small size (17 high-risk patients in each arm) and the relatively high failure rate among patients assigned to the control arm preclude uniform adoption of its fi ndings.…”

Early versus late hormonal therapy for prostate cancer

“…Positive margin rates were significantly lower in the 8-month than the 3-month group (12% vs 23%; P = 0.0106). However, in a recent update [42], biochemical failure rates were similar in both groups at median followup of 37.7 months. Bono et al [37] found improved pathological staging with 6 rather than 3 months of neoadjuvant treatment with goserelin plus bicalutamide, but longer outcomes have not been reported.…”