title: PCA3 score and prostate cancer diagnosis at repeated saturation biopsy. Which cut-off: 20 or 35?
abstract: OBJECTIVE
  To compare PCA3 score cut-off of 35 vs 20 in PCa diagnosis in patients undergoing repeated saturation prostate biopsy (SPBx).
  
  
  METHODS
  From January 2010 to May 2011, 118 patients (median 62.5 years) with primary negative extended biopsy underwent a transperineal SPBx (median 30 cores) for persistent suspicion of PCa. The indications for repeated biopsy were: persistently high or increasing PSA values; PSA > 10 ng/mL, PSA values between 4.1-10 or 2.6-4 ng/mL with free/total PSA ≤ 25% and ≤ 20 %, respectively; moreover, before performing SPBx urinary PCA3 score was evaluated.
  
  
  RESULTS
  All patients had negative DRE and median PSA was 8.5 ng/mL (range: 3.7-24 ng/mL). A T1c PCa was found in 32 patients (27.1 %): PCA3 score was 59 (median; range: 7-201) in the presence of PCa and 35 (median; range: 3-253) in the absence of cancer (p < 0.05). In the presence of ASAP and HGPIN median PCA3 score was 109 (range: 42-253) and 40 (range: 30-140), respectively. Diagnostic accuracy, sensitivity, specificity, PPV and NPV of PCA3 score cut-off of 20 vs 35 in PCa diagnosis were 44.9 vs 50 %, 90.6 vs 71.9 %, 27.9 vs 41.8 %, 31.9 vs 31.5 % and 88.9 vs 80 %, respectively. ROC analysis demonstrated an AUC for PCA3 ≥ 20 vs ≥ 35 of 0.678 and 0.634, respectively.
  
  
  CONCLUSIONS
  Our data suggest that PCA3 is more useful as an exclusion tool; moreover, setting a PCA3 cut-off at 20 vs 35, would have avoided 22.9 vs 38.1 % of biopsies while missing 9.4 % and 28 % diagnosis of PCa.
authors.affiliation: Urology Unit, Cannizzaro Hospital, Pathology Unit, Cannizzaro Hospital and Department of Economy, University of Catania, Catania, Italy. piepepe@hotmail.com
authors.forename: Pietro
authors.initials: P
authors.lastname: Pepe
authors.forename: Filippo
authors.initials: F
authors.lastname: Fraggetta
authors.forename: Antonio
authors.initials: A
authors.lastname: Galia
authors.forename: Giorgio
authors.initials: G
authors.lastname: Skonieczny
authors.forename: Francesco
authors.initials: F
authors.lastname: Aragona
mesh_terms: D017677:Age Distribution; D000368:Aged; D000951:Antigens, Neoplasm / Q000097:blood*; D015415:Biomarkers / Q000097:blood; D001706:Biopsy; D006801:Humans; D008297:Male; D008875:Middle Aged; D011467:Prostate / Q000473:pathology*; D017430:Prostate-Specific Antigen / Q000097:blood*; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000097:blood / Q000473:pathology*; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D000951:Antigens, Neoplasm; D015415:Biomarkers; C479341:prostate cancer antigen 3, human; D017430:Prostate-Specific Antigen