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• W2161484910 abstract "No AccessJournal of UrologyAdult Urology1 May 2013Prospective 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, and William J. Catalona Stacy LoebStacy Loeb Department of Urology, New York University Langone Medical Center, New York, New York More articles by this author , Lori J. SokollLori J. Sokoll Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland Financial interest and/or other relationship with Beckman Coulter. More articles by this author , Dennis L. BroylesDennis L. Broyles Beckman Coulter, Inc. Carlsbad, California Financial interest and/or other relationship with Beckman Coulter. More articles by this author , Chris H. BangmaChris H. Bangma Department of Urology, Erasmus University Medical Center, Rotterdam, The Netherlands More articles by this author , Ron H.N. van SchaikRon H.N. van Schaik Department of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, The Netherlands More articles by this author , George G. KleeGeorge G. Klee Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota Financial interest and/or other relationship with Beckman Coulter. More articles by this author , John T. WeiJohn T. Wei Department of Urology, University of Michigan School of Medicine, Ann Arbor, Michigan Financial interest and/or other relationship with Genprobe and Neotract. More articles by this author , Martin G. SandaMartin G. Sanda Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts Financial interest and/or other relationship with Medicametrix, Sanofi-Aventis, Beckman-Coulter and Carisome. More articles by this author , Alan W. PartinAlan W. Partin Department of Urology, Johns Hopkins University School of Medicine, Baltimore, Maryland More articles by this author , Kevin M. SlawinKevin M. Slawin Vanguard Urologic Institute and Texas Prostate Center, Houston, Texas Financial interest and/or other relationship with Beckman Coulter. More articles by this author , Leonard S. MarksLeonard S. Marks Department of Urology, University of California-Los Angeles, Los Angeles, California Financial interest and/or other relationship with Beckman-Coulter, USHIFU, National Institutes of Health and Eigen. More articles by this author , Isaac A. MizrahiIsaac A. Mizrahi Beckman Coulter, Inc. Carlsbad, California Financial interest and/or other relationship with Beckman Coulter. More articles by this author , Sanghyuk S. ShinSanghyuk S. Shin Beckman Coulter, Inc. Carlsbad, California Financial interest and/or other relationship with Beckman Coulter. More articles by this author , Amabelle B. CruzAmabelle B. Cruz Beckman Coulter, Inc. Carlsbad, California Financial interest and/or other relationship with Beckman Coulter. More articles by this author , Daniel W. ChanDaniel W. Chan Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland More articles by this author , William L. RobertsWilliam L. Roberts ARUP® Laboratories, Department of Pathology, University of Utah, Salt Lake City, Utah Deceased. More articles by this author , and William J. CatalonaWilliam J. Catalona Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, Illinois Financial interest and/or other relationship with Beckman-Coulter, deCODE Genetics and OHMX. More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.11.149AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail 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) × SA. 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. References 1 : Screening for prostate cancer—the controversy that refuses to die. N Engl J Med2009; 360: 1351. Google Scholar 2 : Use of the percentage of free prostate-specific antigen to enhance differentiation of prostate cancer from benign prostatic disease: a prospective multicenter clinical trial. JAMA1998; 279: 1542. Google Scholar 3 : Proenzyme forms of prostate-specific antigen in serum improve the detection of prostate cancer. Clin Chem2004; 50: 1017. Google Scholar 4 : A multicenter study of [−2] pro-prostate specific antigen combined with prostate specific antigen and free prostate specific antigen for prostate cancer detection in the 2.0 to 10.0 ng/ml prostate specific antigen range. J Urol2011; 185: 1650. Link, Google Scholar 5 : Clinical impact of new prostate-specific antigen WHO standardization on biopsy rates and cancer detection. Clin Chem2008; 54: 1999. Google Scholar 6 : Lowering PSA cutoffs to enhance detection of curable prostate cancer. Urology2000; 55: 791. Google Scholar 7 : Multi-center analytical performance evaluation of the Access Hybritech(R) p2PSA immunoassay. Clin Chim Acta2012; 413: 1279. Google Scholar 8 : Measurement of prostate-specific antigen in serum as a screening test for prostate cancer. N Engl J Med1991; 324: 1156. Google Scholar 9 : Comparison of 6 automated assays for total and free prostate-specific antigen with special reference to their reactivity toward the WHO 96/670 reference preparation. Clin Chem2006; 52: 1568. Google Scholar 10 : Prostate specific antigen assay standardization bias could affect clinical decision making. J Urol2008; 180: 1959. Link, Google Scholar 11 : Interchangeability of measurements of total and free prostate-specific antigen in serum with 5 frequently used assay combinations: an update. Clin Chem2006; 52: 59. Google Scholar 12 : Prostate-specific antigen (PSA) isoform p2PSA significantly improves the prediction of prostate cancer at initial extended prostate biopsies in patients with total PSA between 2.0 and 10 ng/ml: results of a prospective study in a clinical setting. Eur Urol2011; 60: 214. Google Scholar © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 5May 2013Page: 1702-1706Supplementary Materials Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.Keywordsprostatemass screeningbiological assaysbiopsyprostatic neoplasmsMetricsAuthor Information Stacy Loeb Department of Urology, New York University Langone Medical Center, New York, New York More articles by this author Lori J. Sokoll Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland Financial interest and/or other relationship with Beckman Coulter. More articles by this author Dennis L. Broyles Beckman Coulter, Inc. Carlsbad, California Financial interest and/or other relationship with Beckman Coulter. More articles by this author Chris H. Bangma Department of Urology, Erasmus University Medical Center, Rotterdam, The Netherlands More articles by this author Ron H.N. van Schaik Department of Clinical Chemistry, Erasmus University Medical Center, Rotterdam, The Netherlands More articles by this author George G. Klee Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota Financial interest and/or other relationship with Beckman Coulter. More articles by this author John T. Wei Department of Urology, University of Michigan School of Medicine, Ann Arbor, Michigan Financial interest and/or other relationship with Genprobe and Neotract. More articles by this author Martin G. Sanda Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts Financial interest and/or other relationship with Medicametrix, Sanofi-Aventis, Beckman-Coulter and Carisome. More articles by this author Alan W. Partin Department of Urology, Johns Hopkins University School of Medicine, Baltimore, Maryland More articles by this author Kevin M. Slawin Vanguard Urologic Institute and Texas Prostate Center, Houston, Texas Financial interest and/or other relationship with Beckman Coulter. More articles by this author Leonard S. Marks Department of Urology, University of California-Los Angeles, Los Angeles, California Financial interest and/or other relationship with Beckman-Coulter, USHIFU, National Institutes of Health and Eigen. More articles by this author Isaac A. Mizrahi Beckman Coulter, Inc. Carlsbad, California Financial interest and/or other relationship with Beckman Coulter. More articles by this author Sanghyuk S. Shin Beckman Coulter, Inc. Carlsbad, California Financial interest and/or other relationship with Beckman Coulter. More articles by this author Amabelle B. Cruz Beckman Coulter, Inc. Carlsbad, California Financial interest and/or other relationship with Beckman Coulter. More articles by this author Daniel W. Chan Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland More articles by this author William L. Roberts ARUP® Laboratories, Department of Pathology, University of Utah, Salt Lake City, Utah Deceased. More articles by this author William J. Catalona Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, Illinois Financial interest and/or other relationship with Beckman-Coulter, deCODE Genetics and OHMX. More articles by this author Expand All Advertisement PDF downloadLoading ..." @default.
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• W2161484910 title "Prospective Multicenter Evaluation of the Beckman Coulter Prostate Health Index Using WHO Calibration" @default.
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