Neoadjuvant hormone therapy: The Canadian trials

The Canadian Urologic Oncology Group has carried out three studies of neoad juvant hormonal therapy (NHT) in prostate cancer. The first, a study of 3 m onths of cyproterone acetate (CPA) 100 mg TID in patients undergoing extern al-beam radiation therapy, showed a benefit with respect to time to biochem ical progression. There are no survival or clinical progression data availa ble from this study, The second study involved 3 months of CPA prior to rad ical prostatectomy compared with radical prostatectomy alone and enrolled 2 00 patients. The probability of biochemical progression at 36 months was si milar in the two groups (CPA 40%; surgery alone 30%; P = 0,3233), More rece ntly, we have carried out a randomized trial of 3 v 8 months of leuprolide plus flutamide prior to radical prostatectomy in 547 patients, Patients wer e stratified by clinical stage, Gleason grade, and serum prostate specific antigen (PSA) concentration. In the 3- and 8-month groups, presurgery PSA c oncentrations were <0.1 ng/mL in 35% v 73%, and >0.3 ng/mL in 37% v 10%, re spectively. In the 3- and 8-month groups, the positive margin rates were 17 % and 5% and the organ-confined rates 71% and 91% (P < 0.01). One-year foll ow-up is now available on the entire cohort, Data regarding time to biochem ical and clinical progression and overall and disease-specific survival wil l be required to determine whether this change in the pathologic findings t ranslates into a patient benefit.