Mp41-04 Exosome Biomarker Clinical Impact on Timing and Decision to Have a Prostate Biopsy

You have accessJournal of UrologyProstate Cancer: Markers I (MP41)1 May 2024MP41-04 EXOSOME BIOMARKER CLINICAL IMPACT ON TIMING AND DECISION TO HAVE A PROSTATE BIOPSY Ronald F. Tutrone, Sonia Kumar, Christian Ray, Jason Alter, Yiyuan Yao, Vinita Verma, Johan Skog, Brian Haynes, Emily Ayre, and David Cahn Ronald F. TutroneRonald F. Tutrone , Sonia KumarSonia Kumar , Christian RayChristian Ray , Jason AlterJason Alter , Yiyuan YaoYiyuan Yao , Vinita VermaVinita Verma , Johan SkogJohan Skog , Brian HaynesBrian Haynes , Emily AyreEmily Ayre , and David CahnDavid Cahn View All Author Informationhttps://doi.org/10.1097/01.JU.0001008896.93851.5b.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The ExoDx Prostate (EPI) Test is a non-DRE urine exosome gene expression biomarker assay that provides informed prostate biopsy decisions. The EPI test performance has been well studied1-4 with a sensitivity of 92% and a negative predictive value (NPV) of 91% for high-grade prostate cancer (HGPCa) Gleason Grade Group (GG) ≥2 and 97% for GG ≥3. In this analysis, we examined the EPI test's impact on prostate biopsy decisions as used routinely in multiple clinics. METHODS: This is a retrospective analysis of original ExoDx Prostate usage and subsequent patient follow up over time in the clinic (N=1365) from 5 institutions. Inclusion criteria were men who had a prior EPI test during 2017 and 2018 (N=1345). Demographic and health outcomes as well as treatment data were collected for all men. An analysis was performed to understand the relevant time frame for analysis of EPI testing to prostate biopsy. Nelson Aalen fit of the hazard rate for biopsy events as well as Kaplan Meier survival curves were assessed. RESULTS: Nelson Aalen fit of the hazard rate of biopsy event (A) showed that the hazard rate is equivalent to EPI outcome at ∼300 days. Cox proportional hazard test (B) shows the hazard ratio of prostate biopsy in high- and low-risk EPI groups is 2.19 and there is a significant difference in biopsy free time between the two groups (p<0.0001). CONCLUSIONS: This analysis demonstrates that EPI testing provides significant clinical impact in the year during which the test is utilized and supports the need for additional EPI testing in subsequent years as future shared decisions regarding diagnostic prostate biopsy are made. Download PPT Source of Funding: Exosome Diagnostics © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e673 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Ronald F. Tutrone More articles by this author 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 David Cahn More articles by this author Expand All Advertisement PDF downloadLoading ...