PNFLBA-11 RADICAL PROSTATECTOMY VERSUS OBSERVATION FOR EARLY PROSTATE CANCER: FOLLOW-UP RESULTS OF THE PROSTATE CANCER INTERVENTION VERSUS OBSERVATION TRIAL (PIVOT)

Abstract

You have accessJournal of UrologyPlenary: Next Frontier (PNFLBA)1 Apr 2017PNFLBA-11 RADICAL PROSTATECTOMY VERSUS OBSERVATION FOR EARLY PROSTATE CANCER: FOLLOW-UP RESULTS OF THE PROSTATE CANCER INTERVENTION VERSUS OBSERVATION TRIAL (PIVOT) Timothy Wilt, Karen Jones, Michael Barry, Gerald Andriole, Daniel Culkin, Thomas Wheeler, William Aronson, and Michael Brawer Timothy WiltTimothy Wilt More articles by this author , Karen JonesKaren Jones More articles by this author , Michael BarryMichael Barry More articles by this author , Gerald AndrioleGerald Andriole More articles by this author , Daniel CulkinDaniel Culkin More articles by this author , Thomas WheelerThomas Wheeler More articles by this author , William AronsonWilliam Aronson More articles by this author , and Michael BrawerMichael Brawer More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.03.037AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES We previously found no mortality differences between surgery and observation in men with localized prostate cancer through 12 years. Uncertainty persists regarding nonfatal health outcomes and long-term mortality. We evaluated clinically important outcomes for men with early stage prostate cancer diagnosed during the early PSA era who were randomly assigned to treatment with either surgery or observation. METHODS Between 1994 and 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 main secondary outcome, prostate cancer mortality. We describe disease progression, additional treatments received and patient reported outcomes through the original follow-up of January 2010. RESULTS During 19.5 years of follow-up (Median=12.7 years), 223 of 364 men (61.3%) assigned to surgery died compared to 245 of 367 (66.8%) assigned to observation; (Absolute risk reduction(ARR)=5.5%, 95% Confidence Interval[CI], -1.5, 12.4); Hazard ratio(HR)=0.84, 95%CI, 0.70, 1.01; P=0.06). Prostate cancer mortality occurred in 27 men (7.4%) randomized to surgery versus 42 men (11.4%) randomized to observation; (ARR = 4.0, 95%CI, -0.2 to 8.3; HR=0.63, 95% CI, 0.39 to 1.02; P=0.06). The effect of surgery on mortality did not vary by baseline patient characteristics. Radical prostatectomy may have reduced all-cause mortality among men with intermediate (ARR=14.5%, 95%CI, 2.8 to 25.6) but not low (ARR=0.6%, 95%CI, -10.5 to 11.8) or high risk disease (ARR=2.3%, 95%CI, -11.5 to 16.1)(P for interaction = 0.08). Surgery reduced disease progression treatment, primarily androgen deprivation for asymptomatic, local or PSA progression, by 26.2 percentage points(95%CI, 19.0 to 32.9). Urinary incontinence, erectile and sexual dysfunction were each greater by more than 30 percentage points with surgery. Disease or treatment related bother and limitations in activities of day-to-day living were greater with surgery though 2 years but not at later follow-up. CONCLUSIONS After nearly 20 years, surgery did not significantly reduce all-cause or prostate cancer mortality compared with observation. Surgery had more adverse effects, but reduced disease progression and subsequent treatments; most asymptomatic, local or biochemical and may have reduced all-cause mortality in men with intermediate risk disease. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e915 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Timothy Wilt More articles by this author Karen Jones More articles by this author Michael Barry More articles by this author Gerald Andriole More articles by this author Daniel Culkin More articles by this author Thomas Wheeler More articles by this author William Aronson More articles by this author Michael Brawer More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...