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- W2317261649 abstract "You have accessJournal of UrologyPlenary I - Tuesday1 Apr 2016PI-LBA08 PRELIMINARY ASSESSMENT OF A VALIDATED URINE EXOSOME ASSAY (EXDX PROSTATE (INTELLISCORE) FOR PREDICTING BIOCHEMICAL RECURRENCE POST-PROSTATECTOMY James Eastham, Michael Donovan, Vip Patel, Vince O'Neill, Stefan Bentink, Johan Skog, and James McKiernan James EasthamJames Eastham More articles by this author , Michael DonovanMichael Donovan More articles by this author , Vip PatelVip Patel More articles by this author , Vince O'NeillVince O'Neill More articles by this author , Stefan BentinkStefan Bentink More articles by this author , Johan SkogJohan Skog More articles by this author , and James McKiernanJames McKiernan More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.03.131AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Non-invasive screening tools that add predictive value for identifying high-grade, Gleason score (GS) =7 should impact on the current diagnostic and subsequent treatment decision process. We recently validated an exosomal-RNA three gene signature from first-catch, non DRE urine test (ExDx Prostate (IntelliScore) that reliably differentiates GS7+ from GS6 and benign at initial biopsy. We have also shown that this signature is associated with Gleason grade and tumor volume in the prostatectomy specimen. We sought to understand the performance of the assay in predicting disease progression post surgery. METHODS Pre-radical prostatectomy first-catch non-DRE urine specimens were collected from 3 urology practices (academic / community practices), stored at 2-8C (up to two weeks) and shipped on ice to a central laboratory (Exosome Diagnostics, St. Paul, MN). Exosomes were isolated and RNA extraction performed. RT-qPCR RNA copy numbers of ERG and PCA3 were normalized to SPDEF. Spearman and Pearson correlation along with AUC were used to evaluate performance. RESULTS Pre-RP urine samples from 359 patients were collected of which 121 had outcome data, median follow-up 2.5 years: 14% GS6, 46% GS7 (3+4), 40% (>/=GS4+3) and >85% PSA <10 ng/mL. The biochemical recurrence (BCR) rate was 19% with 23 recurrences. Applying the validated cut-point of 15.6, the ExDx Prostate (IntelliScore) assay correctly identified >90% of patients with BCR, of which 40% had an ExDx score of >55 (log-rank p value=0.39). Pre-operative PSA was predictive of BCR (p value= 0.003). Of interest, ERG RNA was not detectable in 78% of the patients with BCR. CONCLUSIONS A previously validated non-invasive urine exosome gene signature accurately reflects what is present within the prostatectomy specimen with respect to grade and tumor volume and appears to discriminate disease progression. Additional patients with extended follow-up are necessary to confirm these observations. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e1071-e1072 Advertisement Copyright & Permissions© 2016MetricsAuthor Information James Eastham More articles by this author Michael Donovan More articles by this author Vip Patel More articles by this author Vince O'Neill More articles by this author Stefan Bentink More articles by this author Johan Skog More articles by this author James McKiernan More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ..." @default.
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- W2317261649 title "PI-LBA08 PRELIMINARY ASSESSMENT OF A VALIDATED URINE EXOSOME ASSAY (EXDX PROSTATE (INTELLISCORE) FOR PREDICTING BIOCHEMICAL RECURRENCE POST-PROSTATECTOMY" @default.
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