Prospective multicenter evaluation of the Beckman coulter prostate health index using WHO calibration

Stacy Loeb, Lori J. Sokoll, Dennis L. Broyles, Chris H. Bangma, Ron H.N. Van Schaik, George G. Klee, John T. Wei, Martin G. Sanda, Alan W. Partin, Kevin M. Slawin, Leonard S. Marks, Isaac A. Mizrahi, Sanghyuk S. Shin, Amabelle B. Cruz, Daniel W. Chan, William L. Roberts, William J. Catalona

Research output: Contribution to journalArticlepeer-review

49 Scopus citations

Abstract

Purpose: 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. Materials and 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.

Original languageEnglish (US)
Pages (from-to)1702-1706
Number of pages5
JournalJournal of Urology
Volume189
Issue number5
DOIs
StatePublished - May 2013

Keywords

  • biological assays
  • biopsy
  • mass screening
  • prostate
  • prostatic neoplasms

ASJC Scopus subject areas

  • Urology

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