A prospective, randomized Phase III study comparing radiation vs. cryosurgery for clinically-localized prostate cancer was opened in December 1997 (pT I c - pT3, NO, MO). This trial follows the successful conclusion of our pilot study using cryosurgery in selected cases. Patients will be stratified according to Gleason grade, clinical stage and PSA levels. All patients receive three months of neoadjuvant hormones. The intention is to accrue 240 patients in each arm. Initial end point is biochemical failure. Other early endpoints are PSA and biopsy status at 30 months. Survival is the ultimate endpoint. QOL is a major component of this protocol. 123 patients have been assessed, and 57 are currently randomized (5th Oct.). Only one patient has withdrawn after randomization, and one other was excluded because of other medical problems.
We have demonstrated that a major trial of this complexity can be successfully conducted in Calgary.