title: Prostate cancer incidence and disease-specific survival of men with initial prostate-specific antigen less than 3.0 ng/ml who are participating in ERSPC Rotterdam.
abstract: BACKGROUND
  The European Randomised Study of Screening for Prostate Cancer (ERSPC) applies a prostate-specific antigen (PSA) cut-off value ≥3.0 ng/ml as an indication for lateralised sextant biopsy.
  
  
  OBJECTIVE
  To analyse the incidence and disease-specific mortality for prostate cancer (PCa) in men with an initial PSA <3.0 ng/ml.
  
  
  METHODS
  From November 1993 to December 1999, a total of 42,376 men identified from population registries in the Rotterdam region (55-74 yr of age) were randomised to an intervention or control arm. A total of 19,950 men were screened during the first screening round.
  
  
  METHODS
  A PSA <3.0 ng/ml was below the biopsy threshold. PCa cases were identified at rescreens every 4 yr or as interval cancers.
  
  
  METHODS
  Distribution of incidence, aggressiveness, and disease-specific mortality of PCa per PSA range was measured. Causes of death were evaluated by an independent committee, and follow-up was complete until 31 December 2008.
  
  
  CONCLUSIONS
  From 1993 to 2008, 915 PCa cases were diagnosed in 15,758 men (5.8%) with an initial PSA <3.0 ng/ml and a median age of 62.3 yr. Median overall follow-up was 11 yr. PCa incidence increased significantly with higher initial PSA levels. Aggressive PCa (clinical stage ≥T2c, Gleason score ≥8, PSA >20 ng/ml, positive lymph nodes, or metastases at diagnosis) was detected in 66 of 733 screen-detected PCa cases (9.0%) and 72 of 182 interval-detected PCa cases (39.6%). Twenty-three PCa deaths occurred in the total population (0.15%), with an increasing risk of PCa mortality in men with higher initial PSA values.
  
  
  CONCLUSIONS
  The risk of PCa, aggressive PCa and PCa mortality in a screening population with initial PSA <3.0 ng/ml increases significantly with higher initial PSA levels. These results contribute to the risk stratification and individual management of men in PSA-based screening programmes.
authors.affiliation: Department of Urology, Erasmus MC, University Medical Centre, Rotterdam, The Netherlands. m.bul@erasmusmc.nl
authors.forename: Meelan
authors.initials: M
authors.lastname: Bul
authors.forename: Pim J
authors.initials: PJ
authors.lastname: van Leeuwen
authors.forename: Xiaoye
authors.initials: X
authors.lastname: Zhu
authors.forename: Fritz H
authors.initials: FH
authors.lastname: Schröder
authors.forename: Monique J
authors.initials: MJ
authors.lastname: Roobol
mesh_terms: D000368:Aged; D014408:Biomarkers, Tumor / Q000097:blood; D001706:Biopsy; D015897:Comorbidity; D042241:Early Diagnosis; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008403:Mass Screening / Q000379:methods* / Q000706:statistics & numerical data*; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000378:metabolism / Q000401:mortality* / Q000473:pathology*; D018570:Risk Assessment / Q000379:methods; D012307:Risk Factors; D016019:Survival Analysis
chemical_list: D014408:Biomarkers, Tumor; D017430:Prostate-Specific Antigen