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Urinary Molecular Biomarker Test Impacts Prostate Biopsy Decision Making in Clinical Practice

2018; Lippincott Williams & Wilkins; Volume: 6; Issue: 4 Linguagem: Inglês

10.1016/j.urpr.2018.09.002

2352-0787

Neal D. Shore, Jason Hafron, Timothy Langford, Marshall Stein, Jessica DeHart, Michael K. Brawer, Daphne Hessels, Jack A. Schalken, Wim Van Criekinge, Jack Groskopf, Kirk J. Wojno,

Economic and Financial Impacts of Cancer

No AccessUrology PracticePatient Care1 Jul 2019Urinary Molecular Biomarker Test Impacts Prostate Biopsy Decision Making in Clinical PracticeThis article is commented on by the following:Editorial Commentary Neal Shore, Jason Hafron, Timothy Langford, Marshall Stein, Jessica DeHart, Michael Brawer, Daphne Hessels, Jack Schalken, Wim Van Criekinge, Jack Groskopf, and Kirk Wojno Neal ShoreNeal Shore Carolina Urologic Research Center, Myrtle Beach, South Carolina , Jason HafronJason Hafron Michigan Institute of Urology, Troy, Michigan , Timothy LangfordTimothy Langford Arkansas Urology, Little Rock, Arkansas , Marshall SteinMarshall Stein Memorial Urology Consultants, Houston, Texas , Jessica DeHartJessica DeHart MDxHealth, Inc., Irvine, California , Michael BrawerMichael Brawer MDxHealth, Inc., Irvine, California , Daphne HesselsDaphne Hessels MDxHealth, Inc., Irvine, California , Jack SchalkenJack Schalken Radboud University Medical Center, Nijmegen, The Netherlands , Wim Van CriekingeWim Van Criekinge Ghent University, Ghent, Belgium , Jack GroskopfJack Groskopf †Correspondence: MDxHealth, Irvine, California E-mail Address: [email protected] MDxHealth, Inc., Irvine, California , and Kirk WojnoKirk Wojno Comprehensive Urology, Royal Oak, Michigan View All Author Informationhttps://doi.org/10.1016/j.urpr.2018.09.002AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Introduction: There is an unmet need for noninvasive methods to better identify patients at increased risk for clinically significant prostate cancer. SelectMDx® is a molecular urine test validated for the detection of Gleason score 7 and higher cancers (ISUP [International Society of Urological Pathology] Grade Group 2-5). In this multicenter trial we evaluated the test's impact on prostate biopsy decision making in clinical practice. Methods: The study involved 5 U.S. community urology practices which sequentially enrolled 418 patients who received a SelectMDx test between May 2016 and April 2017 while undergoing evaluation for initial prostate biopsy. All tests were ordered by the urologist for patient management. We determined biopsy and prostate cancer detection rates in patients with SelectMDx positive versus SelectMDx negative results. Results: Of the 418 subjects evaluated with SelectMDx 253 (61%) had negative results and 165 (39%) had positive results. Subsequent biopsy rates for SelectMDx positive and negative cases were 60% (99) and 12% (32), respectively (p <0.001). Time from SelectMDx result to biopsy was shorter for those with positive vs negative results (median 2 vs 5 months, p=0.001). Of patients who underwent biopsy within 3 months of testing 71 (43%) with positive results underwent biopsy and 27 had cancers identified, including 10 greater than Grade Group 2. Of 9 patients with SelectMDx negative results (3.6%) who underwent biopsy 4 were diagnosed with cancer, all Grade Group 2 or less. Conclusions: SelectMDx had a significant impact on initial prostate biopsy decision making. Biopsy rates in SelectMDx positive cases were fivefold higher than in SelectMDx negative cases. These results describe the clinical utility of SelectMDx in real-world community urology practice. References 1. : Radical prostatectomy or watchful waiting in early prostate cancer. N Engl J Med 2014; 370: 932. Google Scholar 2. : Improved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin. N Engl J Med 1997; 337: 295. 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No direct or indirect commercial, personal, academic, political, religious or ethical incentive is associated with publishing this article. © 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsRelated articlesUrology Practice25 Jun 2019Editorial Commentary Volume 6Issue 4July 2019Page: 256-261 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.Keywordsearly detection of cancermolecular diagnostic techniquesliquid biopsyprostate-specific antigenprostatic neoplasmsMetricsAuthor Information Neal Shore Carolina Urologic Research Center, Myrtle Beach, South Carolina Financial interest and/or other relationship with MDxHealth. More articles by this author Jason Hafron Michigan Institute of Urology, Troy, Michigan More articles by this author Timothy Langford Arkansas Urology, Little Rock, Arkansas Financial interest and/or other relationship with MDxHealth. More articles by this author Marshall Stein Memorial Urology Consultants, Houston, Texas More articles by this author Jessica DeHart MDxHealth, Inc., Irvine, California Financial interest and/or other relationship with MDxHealth. More articles by this author Michael Brawer MDxHealth, Inc., Irvine, California Financial interest and/or other relationship with MDxHealth. More articles by this author Daphne Hessels MDxHealth, Inc., Irvine, California Financial interest and/or other relationship with MDxHealth. More articles by this author Jack Schalken Radboud University Medical Center, Nijmegen, The Netherlands More articles by this author Wim Van Criekinge Ghent University, Ghent, Belgium Financial interest and/or other relationship with MDxHealth. More articles by this author Jack Groskopf MDxHealth, Inc., Irvine, California †Correspondence: MDxHealth, Irvine, California E-mail Address: [email protected] Financial interest and/or other relationship with MDxHealth. More articles by this author Kirk Wojno Comprehensive Urology, Royal Oak, Michigan Financial interest and/or other relationship with MDxHealth. More articles by this author Expand All Submitted for publication July 24, 2018. No direct or indirect commercial, personal, academic, political, religious or ethical incentive is associated with publishing this article. Advertisement PDF downloadLoading ...