title: Screening for prostate cancer: results of the Rotterdam section of the European randomized study of screening for prostate cancer.
abstract: BACKGROUND
  Evidence from randomized trials on the effects of screening for prostate cancer (PCa) on disease-specific mortality accumulates slowly with increasing follow-up.
  
  
  OBJECTIVE
  To assess data on PCa-specific mortality in the Rotterdam section of the European Randomized Study of Screening for Prostate Cancer (ERSPC) trial.
  
  
  METHODS
  A randomized controlled trial with randomization after signed, written informed consent (efficacy trial). In the period 1993-1999, a total of 42 376 men aged 54-74 yr were randomized to a screening arm (S-arm) (n = 21 210 with screening every 4 yr, applying a total prostate-specific antigen [PSA] level cut-off ≥ 3.0 ng/ml as biopsy indication) or a control arm (C-arm) (n = 21 166; no intervention).
  
  
  METHODS
  Number of PCas detected per arm depicted by predefined time periods and prognostic groups. PCa-specific mortality analyses using Poisson regression in age group 55-74 yr at randomization and separately in the predefined age group of 55-69 yr.
  
  
  CONCLUSIONS
  After a median follow-up of 12.8 yr, 19 765 men (94.2%) were screened at least once and 2674 PCas were detected (of which 561 [21.0%] were interval PCas). In the C-arm, 1430 PCas were detected, resulting in an excess incidence of 59 PCas per 1000 men randomized (61 PCas per 1000 in age group 55-69 yr). Thirty-two percent of all men randomized have died. PCa-specific mortality relative-risk (RR) reductions of 20.0% overall (age: 55-74 yr; p = 0.042) and 31.6% (age: 55-69 yr; p = 0.004) were found. A 14.1% increase was found in men aged 70-74 yr (not statistically significant). Absolute PCa mortality was 1.8 per 1000 men randomized (2.6 per 1000 men randomized in age group 55-69 yr). The number needed to invite and number needed to manage were 565 and 33, respectively, for age group 55-74 yr, and 392 and 24, respectively, for age group 65-69 yr. Given the slow natural history of the disease, follow-up might be too short.
  
  
  CONCLUSIONS
  Systematic PSA-based screening reduced PCa-specific mortality by 32% in the age range of 55-69 yr. The roughly twofold higher incidence in the S-arm underlines the importance of tools to better identify those men who would benefit from screening.
authors.affiliation: Department of Urology, Erasmus University Medical Center, Rotterdam, The Netherlands. m.roobol@erasmusmc.nl
authors.forename: Monique J
authors.initials: MJ
authors.lastname: Roobol
authors.forename: Ries
authors.initials: R
authors.lastname: Kranse
authors.forename: Chris H
authors.initials: CH
authors.lastname: Bangma
authors.forename: Arno G J L H
authors.initials: AG
authors.lastname: van Leenders
authors.forename: Bert G
authors.initials: BG
authors.lastname: Blijenberg
authors.forename: Ron H N
authors.initials: RH
authors.lastname: van Schaik
authors.forename: Wim J
authors.initials: WJ
authors.lastname: Kirkels
authors.forename: Suzie J
authors.initials: SJ
authors.lastname: Otto
authors.forename: Theo H
authors.initials: TH
authors.lastname: van der Kwast
authors.forename: Harry J
authors.initials: HJ
authors.lastname: de Koning
authors.forename: Fritz H
authors.initials: FH
authors.lastname: Schröder
mesh_terms: D000368:Aged; D001706:Biopsy; D018450:Disease Progression; D018572:Disease-Free Survival; D006801:Humans; D007610:Kallikreins / Q000097:blood*; D008297:Male; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D011237:Predictive Value of Tests; D011379:Prognosis; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood / Q000175:diagnosis* / Q000401:mortality / Q000628:therapy; D012044:Regression Analysis; D012307:Risk Factors; D013997:Time Factors
chemical_list: C549870:KLK3 protein, human; D007610:Kallikreins; D017430:Prostate-Specific Antigen
keywords: Biopsy; Mortality; PSA; Prostate cancer; Screening