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Meta-Analysis
. 2022 Feb;25(2):296-301.
doi: 10.1038/s41391-021-00456-8. Epub 2021 Sep 30.

Predicting high-grade prostate cancer at initial biopsy: clinical performance of the ExoDx (EPI) Prostate Intelliscore test in three independent prospective studies (VSports在线直播)

Erik Margolis  1 , Gordon Brown  2 , Alan Partin  3 , Ballentine Carter  3 , James McKiernan  4 , Ronald Tutrone  5 , Phillipp Torkler  6 , Christian Fischer  6 , Vasisht Tadigotla  7 , Mikkel Noerholm  6 , Michael J Donovan  8 , Johan Skog  7
Affiliations
Meta-Analysis

VSports最新版本 - Predicting high-grade prostate cancer at initial biopsy: clinical performance of the ExoDx (EPI) Prostate Intelliscore test in three independent prospective studies

Erik Margolis et al. Prostate Cancer Prostatic Dis. 2022 Feb.

Abstract

Background: The ability to discriminate indolent from clinically significant prostate cancer (PC) at the initial biopsy remains a challenge VSports手机版. The ExoDx Prostate (IntelliScore) (EPI) test is a noninvasive liquid biopsy that quantifies three RNA targets in urine exosomes. The EPI test stratifies patients for risk of high-grade prostate cancer (HGPC; ≥ Grade Group 2 [GG] PC) in men ≥ 50 years with equivocal prostate-specific antigen (PSA) (2-10 ng/mL). Here, we present a pooled meta-analysis from three independent prospective-validation studies in men presenting for initial biopsy decision. .

Methods: Pooled data from two prospective multi-site validation studies and the control arm of a clinical utility study were analyzed. Performance was evaluated using the area under the receiver-operating characteristic curve (AUC), negative predictive value (NPV), positive predictive value (PPV), sensitivity, and specificity for discriminating ≥ GG2 from GG1 and benign pathology. V体育安卓版.

Results: The combined cohort (n = 1212) of initial-biopsy subjects had a median age of 63 years and median PSA of 5. 2 ng/mL. The EPI AUC (0. 70) was superior to PSA (0. 56), Prostate Cancer Prevention Trial Risk Calculator (PCPT-RC) (0. 62), and The European Randomized Study of Screening for Prostate Cancer (ERSPC) (0. 59), (all p-values <0. 001) for discriminating GG2 from GG1 and benign histology V体育ios版. The validated cutoff of 15. 6 would avoid 23% of all prostate biopsies and 30% of "unnecessary" (benign or Gleason 6/GG1) biopsies, with an NPV of 90%. .

Conclusions: EPI is a noninvasive, easy-to-use, urine exosome-RNA assay that has been validated across 3 independent prospective multicenter clinical trials with 1212 subjects. The test can discriminate high-grade (≥GG2) from low-grade (GG1) cancer and benign disease. EPI effectively guides the biopsy-decision process independent of PSA and other standard-of-care factors VSports最新版本. .

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Conflict of interest statement

P Torkler, M Noerholm, V Tadigotla, C Fischer, and J Skog are employees of Exosome Diagnostics, a Bio-Techne Brand; M Donovan is a consultant to Exosome Diagnostics.

"VSports" Figures

Fig. 1
Fig. 1. Pooled EPI performance using the area under the receiver operator characteristic (AUC) curve.
Area under receiver operating characteristic (AUC) curves illustrates performance of pooled EPI (n = 1212) to discriminate HGPC vs. PCPT-RC, ERSPC RC, and PSA.
Fig. 2
Fig. 2. EPI score and probability of HGPC on a TRUS prostate biopsy.
Bar-chart illustration of binned EPI scores and the probability of finding HGPC on a subsequent TRUS 12-core biopsy.
Fig. 3
Fig. 3. PSA values and probability of HGPC on a TRUS prostate biopsy.
Bar-chart illustration of binned PSA values and the probability of finding HGPC on a subsequent TRUS 12-core biopsy.
Fig. 4
Fig. 4. Pooled EPI Decision-curve analysis.
Decision-curve analysis demonstrating net clinical benefit of EPI in the overall biopsy-decision process.
See this image and copyright information in PMC

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