☆ 4.5 Article

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

PROSTATE CANCER AND PROSTATIC DISEASES (2022)

Journal

PROSTATE CANCER AND PROSTATIC DISEASES

Volume 25, Issue 2, Pages 296-301

Publisher

SPRINGERNATURE

DOI: 10.1038/s41391-021-00456-8

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Exosome Diagnostics

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Abstract

The EPI test is a reliable noninvasive method that can discriminate between high-grade prostate cancer, low-grade cancer, and benign diseases. By pooling data from three independent studies, it was found that the EPI test performs better in distinguishing between prostate cancer pathologies (GG1 and GG2 and above).

Background The ability to discriminate indolent from clinically significant prostate cancer (PC) at the initial biopsy remains a challenge. 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. 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. 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.

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ExoDx prostate test as a predictor of outcomes of high-grade prostate cancer - an interim analysis

Ronald Tutrone, Ben Lowentritt, Brian Neuman, Michael J. J. Donovan, Elliot Hallmark, T. Jeffrey Cole, Yiyuan Yao, Claire Biesecker, Sonia Kumar, Vinita Verma, Grannum R. R. Sant, Jason Alter, Johan Skog

Summary: In the 5-year follow-up of the prostate biopsy Decision Impact Trial, patient outcomes were assessed based on a pre-biopsy ExoDx Prostate (EPI) score at 2.5 years. The results showed that patients with low-risk EPI scores had lower biopsy rates compared to those with high-risk EPI scores, while patients receiving standard of care had the same biopsy rates regardless of EPI score. Additionally, in the EPI arm, the time to first biopsy was longer for patients with low-risk EPI scores. This study demonstrates that the EPI test risk stratification identifies low-risk patients that are not found with the standard of care.

PROSTATE CANCER AND PROSTATIC DISEASES (2023)