title: The time-resolved fluorescence-based PCA3 test on urinary sediments after digital rectal examination; a Dutch multicenter validation of the diagnostic performance.
abstract: OBJECTIVE
  To improve the specificity in prostate cancer diagnosis and to prevent unnecessary prostate biopsies, especially in the serum prostate-specific antigen (PSA) "gray zone" between 3 and 15 ng/mL, the implementation of prostate cancer-specific markers is urgently needed. The recently discovered prostate cancer antigen 3 (PCA3) is such a promising prostate cancer marker. In a previous single institution study, the PCA3 urine test clearly proved to be of diagnostic value. Therefore, the diagnostic performance of the PCA3 urine test was validated in a multicenter study.
  
  
  METHODS
  The first voided urine after digital rectal examination was collected from a total of 583 men with serum PSA levels between 3 and 15 ng/mL who were to undergo prostate biopsies. We determined the PCA3 score in these samples and correlated the results with the results of the prostate biopsies.
  
  
  RESULTS
  A total of 534 men (92%) had an informative sample. The area under the receiver-operating characteristic curve, a measure of the diagnostic accuracy of a test, was 0.66 for the PCA3 urine test and 0.57 for serum PSA. The sensitivity for the PCA3 urine test was 65%, the specificity was 66% (versus 47% for serum PSA), and the negative predictive value was 80%.
  
  
  CONCLUSIONS
  In this multicenter study, we validated the diagnostic performance of the PCA3 urine test in the largest group studied thus far using a PCA3 gene-based test. This study shows that the PCA3 urine test, when used as a reflex test, can improve the specificity in prostate cancer diagnosis and could prevent many unnecessary prostate biopsies.
authors.affiliation: Department of Urology, Radboud University Nijmegen Medical Centre, Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands.
authors.forename: Martijn P M Q
authors.initials: MP
authors.lastname: van Gils
authors.forename: Daphne
authors.initials: D
authors.lastname: Hessels
authors.forename: Onno
authors.initials: O
authors.lastname: van Hooij
authors.forename: Sander A
authors.initials: SA
authors.lastname: Jannink
authors.forename: W Pim
authors.initials: WP
authors.lastname: Peelen
authors.forename: Suzanne L J
authors.initials: SL
authors.lastname: Hanssen
authors.forename: J Alfred
authors.initials: JA
authors.lastname: Witjes
authors.forename: Erik B
authors.initials: EB
authors.lastname: Cornel
authors.forename: Herbert F M
authors.initials: HF
authors.lastname: Karthaus
authors.forename: Geert A H J
authors.initials: GA
authors.lastname: Smits
authors.forename: Gerhard A
authors.initials: GA
authors.lastname: Dijkman
authors.forename: Peter F A
authors.initials: PF
authors.lastname: Mulders
authors.forename: Jack A
authors.initials: JA
authors.lastname: Schalken
mesh_terms: D000368:Aged; D000951:Antigens, Neoplasm / Q000096:biosynthesis*; D001706:Biopsy; D051517:Digital Rectal Examination; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009426:Netherlands; D011237:Predictive Value of Tests; D017430:Prostate-Specific Antigen / Q000652:urine; D011471:Prostatic Neoplasms / Q000175:diagnosis*; D012372:ROC Curve; D012680:Sensitivity and Specificity; D013050:Spectrometry, Fluorescence / Q000379:methods*
chemical_list: D000951:Antigens, Neoplasm; C479341:prostate cancer antigen 3, human; D017430:Prostate-Specific Antigen