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 prostate-cancer 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.).
RCT Entities:
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 prostate-cancer 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.).
Authors: Eva Johansson; Gunnar Steineck; Lars Holmberg; Jan-Erik Johansson; Tommy Nyberg; Mirja Ruutu; Anna Bill-Axelson Journal: Lancet Oncol Date: 2011-08-05 Impact factor: 41.316
Authors: Fritz H Schröder; Jonas Hugosson; Monique J Roobol; Teuvo L J Tammela; Stefano Ciatto; Vera Nelen; Maciej Kwiatkowski; Marcos Lujan; Hans Lilja; Marco Zappa; Louis J Denis; Franz Recker; Alvaro Páez; Liisa Määttänen; Chris H Bangma; Gunnar Aus; Sigrid Carlsson; Arnauld Villers; Xavier Rebillard; Theodorus van der Kwast; Paula M Kujala; Bert G Blijenberg; Ulf-Hakan Stenman; Andreas Huber; Kimmo Taari; Matti Hakama; Sue M Moss; Harry J de Koning; Anssi Auvinen Journal: N Engl J Med Date: 2012-03-15 Impact factor: 91.245
Authors: Anna Bill-Axelson; Lars Holmberg; Mirja Ruutu; Hans Garmo; Jennifer R Stark; Christer Busch; Stig Nordling; Michael Häggman; Swen-Olof Andersson; Stefan Bratell; Anders Spångberg; Juni Palmgren; Gunnar Steineck; Hans-Olov Adami; Jan-Erik Johansson Journal: N Engl J Med Date: 2011-05-05 Impact factor: 91.245
Authors: Patricia A Ganz; John M Barry; Wylie Burke; Nananda F Col; Phaedra S Corso; Everett Dodson; M Elizabeth Hammond; Barry A Kogan; Charles F Lynch; Lee Newcomer; Eric J Seifter; Janet A Tooze; Kasisomayajula Viswanath; Hunter Wessells Journal: Ann Intern Med Date: 2012-02-20 Impact factor: 25.391
Authors: James A Eastham; Michael W Kattan; Elyn Riedel; Colin B Begg; Thomas M Wheeler; Claudia Gerigk; Mithat Gonen; Victor Reuter; Peter T Scardino Journal: J Urol Date: 2003-12 Impact factor: 7.450
Authors: Derek J Rosario; J Athene Lane; Chris Metcalfe; Jenny L Donovan; Andy Doble; Louise Goodwin; Michael Davis; James W F Catto; Kerry Avery; David E Neal; Freddie C Hamdy Journal: BMJ Date: 2012-01-09
Authors: M A Liss; J M Schenk; A V Faino; L F Newcomb; H Boyer; J D Brooks; P R Carroll; A Dash; M D Fabrizio; M E Gleave; P S Nelson; M L Neuhouser; J T Wei; Y Zheng; J L Wright; D W Lin; I M Thompson Journal: Prostate Cancer Prostatic Dis Date: 2016-07-19 Impact factor: 5.554
Authors: Soroush Rais-Bahrami; Barış Türkbey; Ardeshir R Rastinehad; Annerleim Walton-Diaz; Anthony N Hoang; M Minhaj Siddiqui; Lambros Stamatakis; Hong Truong; Jeffrey W Nix; Srinivas Vourganti; Kinzya B Grant; Maria J Merino; Peter L Choyke; Peter A Pinto Journal: Diagn Interv Radiol Date: 2014 Jul-Aug Impact factor: 2.630
Authors: Roxanne Espaldon; Katharine A Kirby; Kathy Z Fung; Richard M Hoffman; Adam A Powell; Stephen J Freedland; Louise C Walter Journal: Urology Date: 2014-01-16 Impact factor: 2.649
Authors: Richard Walker; Alyssa Louis; Alejandro Berlin; Sheri Horsburgh; Robert G Bristow; John Trachtenberg Journal: Can Urol Assoc J Date: 2014-11 Impact factor: 1.862