The Prostate Cancer Intervention Versus Observation Trial (PIVOT) randomized 731 men
with clinically organ-confined (T1-T2) prostate cancer to observation versus radical
prostatectomy. The patients had to be <75 years old and have a prostate-specific antigen
(PSA) <50 ng/mL, but no restrictions were used for Gleason score. The main finding
of the study was that neither the all-cause mortality nor the prostate-cancer mortality
differed between groups after a median follow-up of 10 years. The absolute reduction
in risk of death from all causes was 2.9% with radical prostatectomy and the relative
risk reduction was 12%; however, this was not statistically significant (95% confidence
interval 0.71-1.08, P = .22). The absolute risk reduction for prostate cancer mortality was similar (2.6%).
Although the relative risk reduction for prostate cancer mortality was more pronounced
at 37%, the difference was again not statistically significant (95% confidence interval
0.36-1.09, P = .09). The rate of bone metastasis declined from 10.6% to 4.7% with radical prostatectomy,
for a relative risk reduction of 60% (95% confidence interval 0.22-0.70, P < .001).
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References
- A randomized trial comparing radical prostatectomy with watchful waiting in early prostate cancer.N Engl J Med. 2002; 347: 781-789
- Prostate cancer screening in the randomized Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial: mortality results after 13 years of follow-up.J Natl Cancer Inst. 2012; 104: 125-132
- Prostate-cancer mortality at 11 years of follow-up.N Engl J Med. 2012; 366: 981-990
- (Accessed July 20, 2012)
Article info
Publication history
Published online: October 04, 2012
Timothy J. Wilt, M.D., M.P.H., Michael K. Brawer, M.D., Karen M. Jones, M.S., et al. for the Prostate Cancer Intervention versus Observation Trial (PIVOT) Study Group. N Engl J Med 2012;367:203-213.Identification
Copyright
© 2012 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
