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.
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.
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%.
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.
Prostate cancer and prostatic diseases. 2021 Sep 30 [Epub ahead of print]
Erik Margolis, Gordon Brown, Alan Partin, Ballentine Carter, James McKiernan, Ronald Tutrone, Phillipp Torkler, Christian Fischer, Vasisht Tadigotla, Mikkel Noerholm, Michael J Donovan, Johan Skog
Urology Center of Englewood, Englewood, NJ, USA., Delaware Valley Urology, Vorhees, NJ, USA., Johns Hopkins Hospital, Baltimore, MD, USA., Columbia University Medical Center, New York, NY, USA., Chesapeake Urology Associate, Baltimore, MD, USA., Exosome Diagnostics, a Bio-techne brand, Martinsried, Germany., Exosome Diagnostics, a Bio-techne brand, Waltham, MA, USA., University of Miami, Miami, Florida, USA. .
PubMed http://www.ncbi.nlm.nih.gov/pubmed/34593984