We previously found no significant differences in mortality between men who under- went surgery for localized prostate cancer and those who were treated with observation only. Uncertainty persists regarding nonfatal health outcomes and long-term mortality.
From November 1994 through January 2002, we randomly assigned 731 men with localized prostate cancer to radical prostatectomy or observation. We extended follow-up through August 2014 for our primary outcome, all-cause mortality, and the main secondary outcome, prostate-cancer mortality. We describe disease progression, treatments received, and patient-reported outcomes through January 2010 (original follow-up).
During 19.5 years of follow-up (median, 12.7 years), death occurred in 223 of 364 men (61.3%) assigned to surgery and in 245 of 367 (66.8%) assigned to observation (absolute difference in risk, 5.5 percentage points; 95% confidence interval [CI], −1.5 to 12.4; hazard ratio, 0.84; 95% CI, 0.70 to 1.01; P=0.06). Death attributed to prostate cancer or treatment occurred in 27 men (7.4%) assigned to surgery and in 42 men (11.4%) as- signed to observation (absolute difference in risk, 4.0 percentage points; 95% CI, −0.2 to 8.3; hazard ratio, 0.63; 95% CI, 0.39 to 1.02; P=0.06). Surgery may have been associ- ated with lower all-cause mortality than observation among men with intermediate-risk disease (absolute difference, 14.5 percentage points; 95% CI, 2.8 to 25.6) but not among those with low-risk disease (absolute difference, 0.7 percentage points; 95% CI, −10.5 to 11.8) or high-risk disease (absolute difference, 2.3 percentage points; 95% CI, −11.5 to 16.1) (P=0.08 for interaction). Treatment for disease progression was less frequent with surgery than with observation (absolute difference, 26.2 percentage points; 95% CI, 19.0 to 32.9); treatment was primarily for asymptomatic, local, or biochemical (prostate- specific antigen) progression. Urinary incontinence and erectile and sexual dysfunction were each greater with surgery than with observation through 10 years. Disease-related or treatment-related limitations in activities of daily living were greater with surgery than with observation through 2 years.
After nearly 20 years of follow-up among men with localized prostate cancer, surgery was not associated with significantly lower all-cause or prostate cancer mortality than observation. Surgery was associated with a higher frequency of adverse events than observation but a lower frequency of treatment for disease progression, mostly for asymptomatic, local, or biochemical progression.
(Funded by the Department of Veter- ans Affairs and others; PIVOT ClinicalTrials.gov number, NCT00007644.)
N Engl J Med. 2017 Jul 13;377(2):132-142. doi: 10.1056/NEJMoa1615869.
Timothy J. Wilt, M.D., M.P.H., Karen M. Jones, M.S., Michael J. Barry, M.D., Gerald L. Andriole, M.D., Daniel Culkin, M.D., Thomas Wheeler, M.D., William J. Aronson, M.D., and Michael K. Brawer, M.D.
From the Minneapolis Veterans Affairs (VA) Health Care System and Center for Chronic Disease Outcomes Research and the Section of General Medicine, University of Minnesota School of Medicine, Minneapolis (T.J.W.); the VA Cooperative Studies Program Coordinating Center, Perry Point, MD (K.M.J.); the General Medicine Division, Massachusetts General Hospital, Boston (M.J.B.); the Division of Urology, Washington University School of Medicine, St. Louis (G.L.A.); the Department of Urology, University of Oklahoma College of Medicine, Oklahoma City (D.C.); the Department of Pathology and Immunology, Baylor College of Medicine, Houston (T.W.); VA Medical Center, Greater Los Angeles Healthcare System, Los Angeles (W.J.A.); and Myriad Genetics Laboratories, Salt Lake City (M.K.B.).
AUA 2017: Radical Prostatectomy Versus Observation for Early Prostate Cancer: Follow-Up Results of the Prostate Cancer Intervention Versus Observation Trial (PIVOT)
EAU 2017: Observation or active surveillance or curative treatment: What do PIVOT data tell us?