It is a randomized trial that accrued men from 1994 to 2002. It evaluated all-cause mortality (ACM) and CaP mortality for radical prostatectomy (RP) vs. observation. All men were younger than 75 years. The cumulative mortality was evaluated at 4, 8, and 12 years. 731 were randomized. 364 were randomized to treatment and 281 had RP (others had other treatment modalities) and 367 had observation. Mean PSA was 10.2 and 50% were cT1c. 70% had Gleason score ≤6. 40% were low-risk by D’Amico and 32% were intermediate risk. Median followup was 10 years.
354 men (48%) died and 52 died from CaP (7.1%). All cause mortality found an absolute risk reduction of 2.9%, not statistically significant. Subgroup findings did find patients with PSA greater than 10ng/ml benefited. In low-risk patients, ACM was better in the observation arm. In those with intermediate risk CaP, ACM was reduced 12.6%, but with central pathologic review, it decreased to 4% and was not significant. Prostate cancer mortality reduction was 2.7%, with a 37% reduction with RP, yet not statistically significant. Subgroup evaluation did not alter the findings. Among those with high-risk, RP had a RRR of 8.4%, with HR=0.40. This was not statistically significant.
Overall, CaP mortality was <10%. In high-risk disease it was 10-20%. The ACM and CaP mortality was not significant and was less than 3%.
Presented by Timothy J. Wilt, MD, MPH at the American Urological Association (AUA) Annual Meeting - May 14 - 19, 2011 - Walter E. Washington Convention Center, Washington, DC USA
Reported for UroToday by Christopher P. Evans, MD, FACS, Professor and Chairman, Department of Urology, University of California, Davis, School of Medicine.