title: Mortality results from the Göteborg randomised population-based prostate-cancer screening trial.
abstract: BACKGROUND
  Prostate cancer is one of the leading causes of death from malignant disease among men in the developed world. One strategy to decrease the risk of death from this disease is screening with prostate-specific antigen (PSA); however, the extent of benefit and harm with such screening is under continuous debate.
  
  
  METHODS
  In December, 1994, 20,000 men born between 1930 and 1944, randomly sampled from the population register, were randomised by computer in a 1:1 ratio to either a screening group invited for PSA testing every 2 years (n=10,000) or to a control group not invited (n=10,000). Men in the screening group were invited up to the upper age limit (median 69, range 67-71 years) and only men with raised PSA concentrations were offered additional tests such as digital rectal examination and prostate biopsies. The primary endpoint was prostate-cancer specific mortality, analysed according to the intention-to-screen principle. The study is ongoing, with men who have not reached the upper age limit invited for PSA testing. This is the first planned report on cumulative prostate-cancer incidence and mortality calculated up to Dec 31, 2008. This study is registered as an International Standard Randomised Controlled Trial ISRCTN54449243.
  
  
  RESULTS
  In each group, 48 men were excluded from the analysis because of death or emigration before the randomisation date, or prevalent prostate cancer. In men randomised to screening, 7578 (76%) of 9952 attended at least once. During a median follow-up of 14 years, 1138 men in the screening group and 718 in the control group were diagnosed with prostate cancer, resulting in a cumulative prostate-cancer incidence of 12.7% in the screening group and 8.2% in the control group (hazard ratio 1.64; 95% CI 1.50-1.80; p<0.0001). The absolute cumulative risk reduction of death from prostate cancer at 14 years was 0.40% (95% CI 0.17-0.64), from 0.90% in the control group to 0.50% in the screening group. The rate ratio for death from prostate cancer was 0.56 (95% CI 0.39-0.82; p=0.002) in the screening compared with the control group. The rate ratio of death from prostate cancer for attendees compared with the control group was 0.44 (95% CI 0.28-0.68; p=0.0002). Overall, 293 (95% CI 177-799) men needed to be invited for screening and 12 to be diagnosed to prevent one prostate cancer death.
  
  
  CONCLUSIONS
  This study shows that prostate cancer mortality was reduced almost by half over 14 years. However, the risk of over-diagnosis is substantial and the number needed to treat is at least as high as in breast-cancer screening programmes. The benefit of prostate-cancer screening compares favourably to other cancer screening programs.
  
  
  BACKGROUND
  The Swedish Cancer Society, the Swedish Research Council, and the National Cancer Institute.
authors.affiliation: Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Göteborg, Sweden. jonas@urol.se
authors.forename: Jonas
authors.initials: J
authors.lastname: Hugosson
authors.forename: Sigrid
authors.initials: S
authors.lastname: Carlsson
authors.forename: Gunnar
authors.initials: G
authors.lastname: Aus
authors.forename: Svante
authors.initials: S
authors.lastname: Bergdahl
authors.forename: Ali
authors.initials: A
authors.lastname: Khatami
authors.forename: Pär
authors.initials: P
authors.lastname: Lodding
authors.forename: Carl-Gustaf
authors.initials: CG
authors.lastname: Pihl
authors.forename: Johan
authors.initials: J
authors.lastname: Stranne
authors.forename: Erik
authors.initials: E
authors.lastname: Holmberg
authors.forename: Hans
authors.initials: H
authors.lastname: Lilja
mesh_terms: D000368:Aged; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008403:Mass Screening; D008875:Middle Aged; D016016:Proportional Hazards Models; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000401:mortality / Q000517:prevention & control*; D015996:Survival Rate; D013548:Sweden / Q000453:epidemiology
chemical_list: D017430:Prostate-Specific Antigen