Radical prostatectomy versus observation for localized prostate cancer

Timothy J. Wilt, Michael K. Brawer, Karen M. Jones, Michael J. Barry, William J. Aronson, Steven Fox, Jeffrey R. Gingrich, John T. Wei, Patricia Gilhooly, B. Mayer Grob, Imad Nsouli, Padmini Iyer, Ruben Cartagena, Glenn Snider, Claus Roehrborn, Roohollah Sharifi, William Blank, Parikshit Pandya, Gerald L. Andriole, Daniel CulkinThomas Wheeler

Research output: Contribution to journalArticlepeer-review

1494 Scopus citations


BACKGROUND: The effectiveness of surgery versus observation for men with localized prostate cancer detected by means of prostate-specific antigen (PSA) testing is not known. METHODS: From November 1994 through January 2002, we randomly assigned 731 men with localized prostate cancer (mean age, 67 years; median PSA value, 7.8 ng per milliliter) to radical prostatectomy or observation and followed them through January 2010. The primary outcome was all-cause mortality; the secondary outcome was prostatecancer mortality. RESULTS: During the median follow-up of 10.0 years, 171 of 364 men (47.0%) assigned to radical prostatectomy died, as compared with 183 of 367 (49.9%) assigned to observation (hazard ratio, 0.88; 95% confidence interval [CI], 0.71 to 1.08; P = 0.22; absolute risk reduction, 2.9 percentage points). Among men assigned to radical prostatectomy, 21 (5.8%) died from prostate cancer or treatment, as compared with 31 men (8.4%) assigned to observation (hazard ratio, 0.63; 95% CI, 0.36 to 1.09; P = 0.09; absolute risk reduction, 2.6 percentage points). The effect of treatment on all-cause and prostate-cancer mortality did not differ according to age, race, coexisting conditions, self-reported performance status, or histologic features of the tumor. Radical prostatectomy was associated with reduced all-cause mortality among men with a PSA value greater than 10 ng per milliliter (P = 0.04 for interaction) and possibly among those with intermediate-risk or high-risk tumors (P = 0.07 for interaction). Adverse events within 30 days after surgery occurred in 21.4% of men, including one death. CONCLUSIONS: Among men with localized prostate cancer detected during the early era of PSA testing, radical prostatectomy did not significantly reduce all-cause or prostate-cancer mortality, as compared with observation, through at least 12 years of follow-up. Absolute differences were less than 3 percentage points. (Funded by the Department of Veterans Affairs Cooperative Studies Program and others; PIVOT ClinicalTrials.gov number, NCT00007644.)

Original languageEnglish (US)
Pages (from-to)203-213
Number of pages11
JournalNew England Journal of Medicine
Issue number3
StatePublished - Jul 19 2012

ASJC Scopus subject areas

  • Medicine(all)


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