title: Prospective multicenter evaluation of the Beckman Coulter Prostate Health Index using WHO calibration.
abstract: OBJECTIVE
  Reported prostate specific antigen values may differ substantially among assays using Hybritech® or WHO standardization. The Beckman Coulter® Prostate Health Index and [-2]proPSA are newly approved serum markers associated with prostate cancer risk and aggressiveness. We studied the influence of assay standardization on these markers.
  
  
  METHODS
  Prostate specific antigen, percent free prostate specific antigen and [-2]proPSA were measured using Hybritech calibration in 892 men from a prospective, multicenter study undergoing prostate biopsy. We calculated the Prostate Health Index using the equation, ([-2]proPSA/free prostate specific antigen) × PSA. Index performance characteristics for prostate cancer detection were then determined using recalculated WHO calibration prostate specific antigen values.
  
  
  RESULTS
  The median Prostate Health Index was significantly higher in men with prostate cancer than in those with negative biopsies using WHO values (47.4 vs 39.8, p <0.001). The index offered improved discrimination of prostate cancer detection on biopsy (AUC 0.704) compared to percent free or total prostate specific antigen using the WHO calibration.
  
  
  CONCLUSIONS
  The Prostate Health Index can be calculated using Hybritech or WHO standardized assays. It significantly improved prediction of the biopsy outcome over that of percent free or prostate specific antigen alone.
authors.affiliation: Department of Urology, New York University Langone Medical Center, New York, New York, USA.
authors.forename: Stacy
authors.initials: S
authors.lastname: Loeb
authors.forename: Lori J
authors.initials: LJ
authors.lastname: Sokoll
authors.forename: Dennis L
authors.initials: DL
authors.lastname: Broyles
authors.forename: Chris H
authors.initials: CH
authors.lastname: Bangma
authors.forename: Ron H N
authors.initials: RH
authors.lastname: van Schaik
authors.forename: George G
authors.initials: GG
authors.lastname: Klee
authors.forename: John T
authors.initials: JT
authors.lastname: Wei
authors.forename: Martin G
authors.initials: MG
authors.lastname: Sanda
authors.forename: Alan W
authors.initials: AW
authors.lastname: Partin
authors.forename: Kevin M
authors.initials: KM
authors.lastname: Slawin
authors.forename: Leonard S
authors.initials: LS
authors.lastname: Marks
authors.forename: Isaac A
authors.initials: IA
authors.lastname: Mizrahi
authors.forename: Sanghyuk S
authors.initials: SS
authors.lastname: Shin
authors.forename: Amabelle B
authors.initials: AB
authors.lastname: Cruz
authors.forename: Daniel W
authors.initials: DW
authors.lastname: Chan
authors.forename: William L
authors.initials: WL
authors.lastname: Roberts
authors.forename: William J
authors.initials: WJ
authors.lastname: Catalona
mesh_terms: D015415:Biomarkers / Q000097:blood; D002138:Calibration; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood*; D014944:World Health Organization
chemical_list: D015415:Biomarkers; D017430:Prostate-Specific Antigen