title: Clinical evaluation of the PCA3 assay in guiding initial biopsy decisions.
abstract: OBJECTIVE
  We evaluated the clinical utility of the PCA3 assay in guiding initial biopsy decisions in prostate cancer.
  
  
  METHODS
  A European, prospective, multicenter study enrolled men with a serum total prostate specific antigen of 2.5 to 10 ng/ml scheduled for initial biopsy. After digital rectal examination first catch urine was collected. PCA3 scores were determined using the PROGENSA(®) PCA3 assay and compared to biopsy outcome. The diagnostic accuracy of PCA3 was compared to total prostate specific antigen, prostate specific antigen density and %free prostate specific antigen.
  
  
  RESULTS
  In 516 men the positive biopsy rate was 40%. An increasing PCA3 score corresponded with an increasing probability of a positive biopsy. The mean PCA3 score was higher in men with a positive vs a negative biopsy (69.6 vs 31.0, median 50 vs 18, p <0.0001). The PCA3 score was independent of age, total prostate specific antigen and prostate volume. The PCA3 score (cutoff of 35) had a sensitivity of 64% and specificity of 76%. ROC analysis showed a significantly higher AUC for the PCA3 score vs total prostate specific antigen, prostate specific antigen density and %free prostate specific antigen. The PCA3 score was significantly higher in men with biopsy Gleason score 7 or greater vs less than 7, greater than 33% vs 33% or fewer positive cores and significant vs indolent prostate cancer. Inclusion of PCA3 in multivariable models increased their predictive accuracy by up to 5.5%.
  
  
  CONCLUSIONS
  The PROGENSA PCA3 assay can aid in guiding biopsy decisions. It is superior to total prostate specific antigen, prostate specific antigen density and %free prostate specific antigen in predicting initial biopsy outcome, and may be indicative of prostate cancer aggressiveness.
authors.affiliation: CHU Henri Mondor, Paris, France. adelataille@hotmail.com
authors.forename: Alexandre
authors.initials: A
authors.lastname: de la Taille
authors.forename: Jacques
authors.initials: J
authors.lastname: Irani
authors.forename: Markus
authors.initials: M
authors.lastname: Graefen
authors.forename: Felix
authors.initials: F
authors.lastname: Chun
authors.forename: Theo
authors.initials: T
authors.lastname: de Reijke
authors.forename: Paul
authors.initials: P
authors.lastname: Kil
authors.forename: Paolo
authors.initials: P
authors.lastname: Gontero
authors.forename: Alain
authors.initials: A
authors.lastname: Mottaz
authors.forename: Alexander
authors.initials: A
authors.lastname: Haese
mesh_terms: D000368:Aged; D000951:Antigens, Neoplasm / Q000652:urine*; D001706:Biopsy; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011446:Prospective Studies; D011467:Prostate / Q000473:pathology*; D011471:Prostatic Neoplasms / Q000473:pathology* / Q000652:urine*
chemical_list: D000951:Antigens, Neoplasm; C479341:prostate cancer antigen 3, human