title: Mortality results from a randomized prostate-cancer screening trial.
abstract: BACKGROUND
  The effect of screening with prostate-specific-antigen (PSA) testing and digital rectal examination on the rate of death from prostate cancer is unknown. This is the first report from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial on prostate-cancer mortality.
  
  
  METHODS
  From 1993 through 2001, we randomly assigned 76,693 men at 10 U.S. study centers to receive either annual screening (38,343 subjects) or usual care as the control (38,350 subjects). Men in the screening group were offered annual PSA testing for 6 years and digital rectal examination for 4 years. The subjects and health care providers received the results and decided on the type of follow-up evaluation. Usual care sometimes included screening, as some organizations have recommended. The numbers of all cancers and deaths and causes of death were ascertained.
  
  
  RESULTS
  In the screening group, rates of compliance were 85% for PSA testing and 86% for digital rectal examination. Rates of screening in the control group increased from 40% in the first year to 52% in the sixth year for PSA testing and ranged from 41 to 46% for digital rectal examination. After 7 years of follow-up, the incidence of prostate cancer per 10,000 person-years was 116 (2820 cancers) in the screening group and 95 (2322 cancers) in the control group (rate ratio, 1.22; 95% confidence interval [CI], 1.16 to 1.29). The incidence of death per 10,000 person-years was 2.0 (50 deaths) in the screening group and 1.7 (44 deaths) in the control group (rate ratio, 1.13; 95% CI, 0.75 to 1.70). The data at 10 years were 67% complete and consistent with these overall findings.
  
  
  CONCLUSIONS
  After 7 to 10 years of follow-up, the rate of death from prostate cancer was very low and did not differ significantly between the two study groups. (ClinicalTrials.gov number, NCT00002540.)
authors.affiliation: Washington University School of Medicine, St. Louis, USA.
authors.forename: Gerald L
authors.initials: GL
authors.lastname: Andriole
authors.forename: E David
authors.initials: ED
authors.lastname: Crawford
authors.forename: Robert L
authors.initials: RL
authors.lastname: Grubb
authors.forename: Saundra S
authors.initials: SS
authors.lastname: Buys
authors.forename: David
authors.initials: D
authors.lastname: Chia
authors.forename: Timothy R
authors.initials: TR
authors.lastname: Church
authors.forename: Mona N
authors.initials: MN
authors.lastname: Fouad
authors.forename: Edward P
authors.initials: EP
authors.lastname: Gelmann
authors.forename: Paul A
authors.initials: PA
authors.lastname: Kvale
authors.forename: Douglas J
authors.initials: DJ
authors.lastname: Reding
authors.forename: Joel L
authors.initials: JL
authors.lastname: Weissfeld
authors.forename: Lance A
authors.initials: LA
authors.lastname: Yokochi
authors.forename: Barbara
authors.initials: B
authors.lastname: O'Brien
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Clapp
authors.forename: Joshua M
authors.initials: JM
authors.lastname: Rathmell
authors.forename: Thomas L
authors.initials: TL
authors.lastname: Riley
authors.forename: Richard B
authors.initials: RB
authors.lastname: Hayes
authors.forename: Barnett S
authors.initials: BS
authors.lastname: Kramer
authors.forename: Grant
authors.initials: G
authors.lastname: Izmirlian
authors.forename: Anthony B
authors.initials: AB
authors.lastname: Miller
authors.forename: Paul F
authors.initials: PF
authors.lastname: Pinsky
authors.forename: Philip C
authors.initials: PC
authors.lastname: Prorok
authors.forename: John K
authors.initials: JK
authors.lastname: Gohagan
authors.forename: Christine D
authors.initials: CD
authors.lastname: Berg
mesh_terms: D000368:Aged; D051517:Digital Rectal Examination / Q000009:adverse effects; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008403:Mass Screening / Q000009:adverse effects; D008875:Middle Aged; D010349:Patient Compliance; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000175:diagnosis / Q000453:epidemiology / Q000401:mortality*; D014481:United States / Q000453:epidemiology
chemical_list: D017430:Prostate-Specific Antigen