PD42-12 CLINICAL IMPACT OF AN INTEGRATED ExoDx PROSTATE BIOMARKER AND mpMRI FOR HGPCA RISK ASSESSMENT: PRACTICE PATTERNS, AND PERFORMANCE IN THE CLINIC

You have accessJournal of UrologyProstate Cancer: Markers II (PD42)1 May 2024PD42-12 CLINICAL IMPACT OF AN INTEGRATED ExoDx PROSTATE BIOMARKER AND mpMRI FOR HGPCA RISK ASSESSMENT: PRACTICE PATTERNS, AND PERFORMANCE IN THE CLINIC Sonia Kumar, Christian Ray, Jason Alter, Yiyuan Yao, Vinita Verma, Johan Skog, Brian Haynes, Emily Ayre, Ronald F. Tutrone, and David Cahn Sonia KumarSonia Kumar , Christian RayChristian Ray , Jason AlterJason Alter , Yiyuan YaoYiyuan Yao , Vinita VermaVinita Verma , Johan SkogJohan Skog , Brian HaynesBrian Haynes , Emily AyreEmily Ayre , Ronald F. TutroneRonald F. Tutrone , and David CahnDavid Cahn View All Author Informationhttps://doi.org/10.1097/01.JU.0001008560.54103.65.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: mpMRI limitations have resulted in conflicting recommendations from the National Comprehensive Cancer Network (NCCN)1 and American Urology Association (AUA)2 prior to initial biopsy. Simultaneously, biomarkers have gained support as a complimentary risk assessment method to mpMRI.3 The ExoDx Prostate (EPI) test is a urine exosome gene expression assay that suggests risk of finding high-grade prostate cancer (HGPCa, defined as ≥GG2), without requiring a DRE.4 In this analysis, we examined multiple aspects of biomarker and mpMRI interaction and performance in the clinic. METHODS: This is a retrospective analysis of EPI use and subsequent patient follow up in the clinic (N=1365) from 5 institutions. Inclusion criteria were men who had an EPI test during 2017 and 2018. Demographic, health outcomes and treatment data were collected for all men. The existing test cut point (15.6) was evaluated as well as alternative cut points. A Nelson Aalen fit of the hazard rate for biopsy events was performed to understand the relevant time frame for analysis of EPI testing to prostate biopsy (Bx). Performance metrics included area under the curve (AUC), negative and positive predictive values (NPV, PPV), and Kaplan Meier survival curves. Subset analysis was performed for men with only a biomarker result (N=1365), men with an EPI and Bx within one-year (N=540), men with EPI and mpMRI within one year (N=418), and men with an EPI result followed by an mpMRI and prostate Bx within one year (N=142). RESULTS: A majority (69%) of cases employed EPI prior to mpMRI. Positive correlation was observed between EPI and mpMRI results, and both methods provided independent but overlapping information. A time frame of one year was selected for analysis because the Nelson Aalen fit of the hazard rate of Bx event showed the hazard rate as equivalent to EPI outcome at ∼300 days. In men with EPI, mpMRI and a Bx within one year, the AUC for EPI and mpMRI were not statistically different (p=0.4097); but, the AUC was significantly better when both EPI and mpMRI were combined than for either alone (p<0.00751). Also, when EPI was used post-mpMRI, a very high NPV (100%) resulted regardless of PIRADS score. An alternative cut point (20) demonstrated that NPV and sensitivity only dropped slightly. CONCLUSIONS: This retrospective analysis demonstrates that (a) EPI and mpMRI provide complementary, superior clinical benefits. (b) In real-world practice, physicians primarily use the EPI test prior to mpMRI. (c) EPI makes significant clinical impact in the first year of test use and analysis suggests benefits of repeat testing in subsequent years as future shared-biopsy decisions are made. Source of Funding: Exosome Diagnostics, Inc © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e897 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Sonia Kumar More articles by this author Christian Ray More articles by this author Jason Alter More articles by this author Yiyuan Yao More articles by this author Vinita Verma More articles by this author Johan Skog More articles by this author Brian Haynes More articles by this author Emily Ayre More articles by this author Ronald F. Tutrone More articles by this author David Cahn More articles by this author Expand All Advertisement PDF downloadLoading ...