title: The Risk of Distant Metastases and Cancer Specific Survival in Men with Serum Prostate Specific Antigen Values above 100 ng/ml.
abstract: OBJECTIVE
  Current EAU (European Association of Urology) guidelines state that prostate specific antigen 100 ng/ml or greater at diagnosis indicates metastatic disease. We examined the association of prostate specific antigen 100 ng/ml or greater at diagnosis with distant metastasis and prostate cancer specific survival.
  
  
  METHODS
  A total of 15,635 men with prostate cancer diagnosed between 1998 and 2009 who were identified in PCBaSe (Prostate Cancer Data Base Sweden 2.0) were included in a population based registry study. Prostate cancer specific survival was compared among 3 groups, including 1,879 men with prostate specific antigen 100 ng/ml or greater and negative imaging (M0), 5,642 with distant metastases on imaging (M1) and prostate specific antigen 100 ng/ml or greater, and 3,828 with M1 and prostate specific antigen less than 100 ng/ml. A fourth group consisted of 4,286 men with prostate specific antigen 100 ng/ml or greater who had not undergone imaging (Mx). The latter men were not included in the assessment of survival.
  
  
  RESULTS
  Of 7,521 men with prostate specific antigen 100 ng/ml or greater who underwent imaging for staging 75% were classified with M1 disease. Only 59% of 3,527 men with prostate specific antigen 100 to 300 mg/ml had distant metastases on imaging. Five-year prostate cancer specific survival was 72% (95% CI 70-74) in men with prostate specific antigen 100 ng/ml or greater and M0, 24% (95% CI 23-25) in men with prostate specific antigen 100 ng/ml or greater and M1, and 39% (95% CI 37-40) in men with prostate specific antigen less than 100 ng/ml and M1.
  
  
  CONCLUSIONS
  A fourth of men with prostate specific antigen 100 ng/ml or greater did not have distant metastases. They had twofold to threefold higher 5-year survival than men with distant metastases on imaging. Our findings strongly suggest that using prostate specific antigen 100 ng/ml or greater as an indicator of metastatic disease should be reconsidered.
authors.affiliation: Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.
authors.forename: Karl
authors.initials: K
authors.lastname: Stattin
authors.affiliation: Regional Cancer Center, Uppsala University Hospital, Uppsala, Sweden.
authors.forename: Fredrik
authors.initials: F
authors.lastname: Sandin
authors.affiliation: Urological Cancer Research Unit, Department of Translational Medicine, Lund University, Lund, Sweden; Department of Urology, Cambridge Hospitals, Cambridge, United Kingdom.
authors.forename: Ola
authors.initials: O
authors.lastname: Bratt
authors.affiliation: Regional Cancer Center, Uppsala University Hospital, Uppsala, Sweden; Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden. Electronic address: mats.lambe@ki.se.
authors.forename: Mats
authors.initials: M
authors.lastname: Lambe
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality* / Q000473:pathology*; D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor / Q000097:blood*; D018450:Disease Progression; D055088:Early Detection of Cancer; D019983:Guideline Adherence; D006801:Humans; D016013:Likelihood Functions; D008297:Male; D009362:Neoplasm Metastasis / Q000473:pathology; D009367:Neoplasm Staging; D011237:Predictive Value of Tests; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000401:mortality* / Q000473:pathology*; D012042:Registries; D012306:Risk; D013548:Sweden
chemical_list: D014408:Biomarkers, Tumor; D017430:Prostate-Specific Antigen
keywords: Sweden; adenocarcinoma; neoplasm metastasis; prostate-specific antigen; prostatic neoplasms