| Popis: |
BACKGROUND The ability to discriminate indolent from clinically significant prostate cancer (PC) in the initial biopsy setting remains an important health issue. ExoDx Prostate(IntelliScore) (EPI), is a non-invasive exosome based liquid biopsy test that quantifies three RNA targets in exosomes from urine. The EPI test is used to help stratify patients for risk of high grade prostate cancer, HGPC (≥ GG2 PC) in men 50 years or older with PSA in the gray zone (2–10 ng/mL). The EPI test has been extensively validated and is included in the NCCN guidelines for prostate cancer early detection. Here we present a pooled meta-analysis from three independent prospective validation studies in men presenting for initial biopsy decision. Age range and PSA level subgroups were also analyzed for EPI performance.METHODS Pooled data from two prospective multi-site validation studies and the control arm of a clinical utility study were analyzed. The data from these three independent trials is presented for men 50 years or older with PSA 2–10 ng/ml presenting for their initial prostate biopsy as well as a subgroup of patients between 55–69 years as recommended by the USPSTF (United States Preventative Services Task Force) and PSA greater than 3 ng/mL as per NCCN 2020 guidelines. Diagnostic needle biopsy outcomes were compared with the EPI score, PSA and both the Prostate Cancer Prevention Trial (PCPT 2.0) and the European Randomized Study of Screening for Prostate Cancer (ERSPC) risk calculators. 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, median PSA 5.2 ng/mL and 17% African ancestry. The positive biopsy rate was 52% for ≥ GG1, 30% ≥GG2 and 14% ≥GG3. The EPI AUC of 0.70 was superior to PSA (AUC:0.56), PCPTRC (AUC: 0.62), and ERSPC (AUC: 0.59), (all p-values |
