PD11-11 A URINARY EXOSOME ASSAY INTERROGATING SMALL NON-CODING RNAS ACCURATELY IDENTIFIES AND STRATIFIES PROSTATE CANCER INTO LOW- INTERMEDIATE- OR HIGH-RISK DISEASE

Abstract

You have accessJournal of UrologyCME1 May 2022PD11-11 A URINARY EXOSOME ASSAY INTERROGATING SMALL NON-CODING RNAS ACCURATELY IDENTIFIES AND STRATIFIES PROSTATE CANCER INTO LOW- INTERMEDIATE- OR HIGH-RISK DISEASE Laurence Klotz, Winnie Wang, Alvin Lopez Pujals, Deepak Kapoor, Rebecca DeVaux, Greg DiRienzo, Federico Corica, Ann Anderson, Carl Olsson, Alberto Corica, James Libby, and Martin Tenniswood Laurence KlotzLaurence Klotz More articles by this author , Winnie WangWinnie Wang More articles by this author , Alvin Lopez PujalsAlvin Lopez Pujals More articles by this author , Deepak KapoorDeepak Kapoor More articles by this author , Rebecca DeVauxRebecca DeVaux More articles by this author , Greg DiRienzoGreg DiRienzo More articles by this author , Federico CoricaFederico Corica More articles by this author , Ann AndersonAnn Anderson More articles by this author , Carl OlssonCarl Olsson More articles by this author , Alberto CoricaAlberto Corica More articles by this author , James LibbyJames Libby More articles by this author , and Martin TenniswoodMartin Tenniswood More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002537.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The miR Sentinel® Test measures the expression of 442 small non-coding RNAs (sncRNAs) extracted from urinary exosomes to differentiate patients with No Molecular Evidence of Prostate Cancer (NMEPCa) from those with Molecular Evidence of Prostate Cancer (MEPCa). The test further classifies men with MEPCa into low-, intermediate- or high-risk disease. We compared the results of the miR Sentinel® PCC4 Test to systematic and MRI-guided core needle biopsy in men at risk for prostate cancer. METHODS: 763 biopsy naïve men in whom a prostate biopsy was indicated, were recruited. sncRNAs were isolated from urinary exosomes and interrogated by RT-qPCR on a custom designed OpenArray platform. RESULTS: The validation cohort consisted of 763 biopsy naïve patients undergoing systematic or systematic plus targeted biopsy. The molecular classification was compared to the Gleason Grade Group (GG) (Table 1). Sensitivity for the classification of {NPEPC or GG1} versus {GG2-5} was 75+18+4+105=203)/221=92.2% and the negative predictive value for absence of CS PCa was (221+64+12+123=420)/(238+200=420)= 96%. The apparent false positive rate for CS cancer was (34+35+32+22=(123)/(543) = 23%. 208 of the patients had discordant systematic and targeted biopsies. 29 of these had a negative systematic biopsy and a positive targeted biopsy. The molecular test predicted the targeted biopsy outcome in 27/29=93.1% overall, and in 14/15 (93%) of the cases with clinically significant cancer. In the 18 patients with positive systematic and negative MRI targeted biopsies, the test result predicted the positive biopsy in 100%. CONCLUSIONS: The miR Sentinel Test offers an accurate non-invasive means to accurately identify the presence or absence of prostate cancer and classify risk status predict pathological grade on biopsy. The high predictive accuracy of the test in patients whose systematic and targeted biopsy were discordant suggests that the 23% discordance between negative biopsy results and positive Sentinel Test results was in most cases due to false negative biopsies. Source of Funding: The study was funded by miR Scientific © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e194 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Laurence Klotz More articles by this author Winnie Wang More articles by this author Alvin Lopez Pujals More articles by this author Deepak Kapoor More articles by this author Rebecca DeVaux More articles by this author Greg DiRienzo More articles by this author Federico Corica More articles by this author Ann Anderson More articles by this author Carl Olsson More articles by this author Alberto Corica More articles by this author James Libby More articles by this author Martin Tenniswood More articles by this author Expand All Advertisement PDF DownloadLoading ...