Abstract
BackgroundA prostate cancer diagnosis is based on biopsy sampling that is an invasive, expensive procedure, and doesn’t accurately represent multifocal disease.MethodsTo establish a model using plasma miRs to distinguish Prostate cancer patients from non-cancer controls, we enrolled 600 patients histologically diagnosed as having or not prostate cancer at biopsy. Two hundred ninety patients were eligible for the analysis. Samples were randomly divided into discovery and validation cohorts.ResultsNGS-miR-expression profiling revealed a miRs signature able to distinguish prostate cancer from non-cancer plasma samples. Of 51 miRs selected in the discovery cohort, we successfully validated 5 miRs (4732-3p, 98-5p, let-7a-5p, 26b-5p, and 21-5p) deregulated in prostate cancer samples compared to controls (p ≤ 0.05). Multivariate and ROC analyses show miR-26b-5p as a strong predictor of PCa, with an AUC of 0.89 (CI = 0.83–0.95;p < 0.001). Combining miRs 26b-5p and 98-5p, we developed a model that has the best predictive power in discriminating prostate cancer from non-cancer (AUC = 0.94; CI: 0,835-0,954).To distinguish between low and high-grade prostate cancer, we found that miR-4732-3p levels were significantly higher; instead, miR-26b-5p and miR-98-5p levels were lower in low-grade compared to the high-grade group (p ≤ 0.05).Combining miR-26b-5p and miR-4732-3p we have the highest diagnostic accuracy for high-grade prostate cancer patients, (AUC = 0.80; CI 0,69-0,873).ConclusionsNoninvasive diagnostic tests may reduce the number of unnecessary prostate biopsies.The 2-miRs-diagnostic model (miR-26b-5p and miR-98-5p) and the 2-miRs-grade model (miR-26b-5p and miR-4732-3p) are promising minimally invasive tools in prostate cancer clinical management.
Highlights
A prostate cancer diagnosis is based on biopsy sampling that is an invasive, expensive procedure, and doesn’t accurately represent multifocal disease
A significant challenge in Prostate cancer (PCa) clinical management is posed by the inability of the current diagnostic tests, such as serum Prostate-specific antigen (PSA) testing, digital rectal examination (DRE), to diagnose prostate cancer accurately and to discern between indolent and aggressive disease [3,4,5,6]
We selected a total of 70 patients that underwent 12-core transrectal ultrasound (TRUS) biopsy, of which 48% had cancer at the diagnosis
Summary
A prostate cancer diagnosis is based on biopsy sampling that is an invasive, expensive procedure, and doesn’t accurately represent multifocal disease. A significant challenge in PCa clinical management is posed by the inability of the current diagnostic tests, such as serum Prostate-specific antigen (PSA) testing, digital rectal examination (DRE), to diagnose prostate cancer accurately and to discern between indolent and aggressive disease [3,4,5,6]. Several promising alternative tissue-based assays are being developed based on the molecular characterization of primary and metastatic prostate tumors that show improved sensitivity and specificity over PSA [4]. These assays are based on biopsy sampling, an invasive, expensive procedure, and does not accurately represent multifocal diseases
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