title: Radical prostatectomy versus watchful waiting in early prostate cancer.
abstract: BACKGROUND
  In 2008, we reported that radical prostatectomy, as compared with watchful waiting, reduces the rate of death from prostate cancer. After an additional 3 years of follow-up, we now report estimated 15-year results.
  
  
  METHODS
  From October 1989 through February 1999, we randomly assigned 695 men with early prostate cancer to watchful waiting or radical prostatectomy. Follow-up was complete through December 2009, with histopathological review of biopsy and radical-prostatectomy specimens and blinded evaluation of causes of death. Relative risks, with 95% confidence intervals, were estimated with the use of a Cox proportional-hazards model.
  
  
  RESULTS
  During a median of 12.8 years, 166 of the 347 men in the radical-prostatectomy group and 201 of the 348 in the watchful-waiting group died (P=0.007). In the case of 55 men assigned to surgery and 81 men assigned to watchful waiting, death was due to prostate cancer. This yielded a cumulative incidence of death from prostate cancer at 15 years of 14.6% and 20.7%, respectively (a difference of 6.1 percentage points; 95% confidence interval [CI], 0.2 to 12.0), and a relative risk with surgery of 0.62 (95% CI, 0.44 to 0.87; P=0.01). The survival benefit was similar before and after 9 years of follow-up, was observed also among men with low-risk prostate cancer, and was confined to men younger than 65 years of age. The number needed to treat to avert one death was 15 overall and 7 for men younger than 65 years of age. Among men who underwent radical prostatectomy, those with extracapsular tumor growth had a risk of death from prostate cancer that was 7 times that of men without extracapsular tumor growth (relative risk, 6.9; 95% CI, 2.6 to 18.4).
  
  
  CONCLUSIONS
  Radical prostatectomy was associated with a reduction in the rate of death from prostate cancer. Men with extracapsular tumor growth may benefit from adjuvant local or systemic treatment. (Funded by the Swedish Cancer Society and the National Institutes of Health.).
authors.affiliation: Department of Urology, University Hospital, Uppsala, Sweden. anna.bill.axelson@akademiska.se
authors.forename: Anna
authors.initials: A
authors.lastname: Bill-Axelson
authors.forename: Lars
authors.initials: L
authors.lastname: Holmberg
authors.forename: Mirja
authors.initials: M
authors.lastname: Ruutu
authors.forename: Hans
authors.initials: H
authors.lastname: Garmo
authors.forename: Jennifer R
authors.initials: JR
authors.lastname: Stark
authors.forename: Christer
authors.initials: C
authors.lastname: Busch
authors.forename: Stig
authors.initials: S
authors.lastname: Nordling
authors.forename: Michael
authors.initials: M
authors.lastname: Häggman
authors.forename: Swen-Olof
authors.initials: SO
authors.lastname: Andersson
authors.forename: Stefan
authors.initials: S
authors.lastname: Bratell
authors.forename: Anders
authors.initials: A
authors.lastname: Spångberg
authors.forename: Juni
authors.initials: J
authors.lastname: Palmgren
authors.forename: Gunnar
authors.initials: G
authors.lastname: Steineck
authors.forename: Hans-Olov
authors.initials: HO
authors.lastname: Adami
authors.forename: Jan-Erik
authors.initials: JE
authors.lastname: Johansson
mesh_terms: D000367:Age Factors; D000368:Aged; D005500:Follow-Up Studies; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D016016:Proportional Hazards Models; D011467:Prostate / Q000473:pathology / Q000601:surgery; D011468:Prostatectomy / Q000379:methods; D011471:Prostatic Neoplasms / Q000401:mortality / Q000601:surgery*; D012306:Risk; D012307:Risk Factors; D016019:Survival Analysis; D057832:Watchful Waiting