Reduced Rate of Repeated Prostate Biopsies Observed in ConfirmMDx Clinical Utility Field Study

摘要: Background The diagnosis of prostate cancer is dependent on histologic confirmation in biopsy core tissues. procedure invasive, puts the patient at risk for complications, and subject to significant sampling errors. An epigenetic test that uses methylation-specific polymerase chain reaction determine status cancer-associated genes GSTP1, APC, RASSF1 has been clinically validated used clinical practice increase negative predictive value men with no history compared standard histopathology. Such information can help avoid unnecessary repeat biopsies. rate may provide preliminary utility evidence relation this assay's potential impact number biopsies performed US urology practices. Objective purpose study was quantify procedures demonstrate a low histopathology who received assay result testing residual tissue. Methods In recently completed field observation study, practicing urologists called ConfirmMDx Prostate Cancer (MDxHealth, Inc, Irvine, CA) evaluate cancer-negative considered cancer. This previously 2 blinded multicenter studies showed superior over detection A total 5 practices had ordered minimum 40 commercial requisitions patients previous, course previous 18 months were contacted assess their interest participate study. Select demographic prostate-screening parameter information, as well incidence biopsy, specifically result, collected merged into 1 collective database. All from each sites results included analysis. Results 138 identified these median age 63 years, current serum prostate-specific antigen level 4.7 ng/mL. Repeat 6 (4.3%) whom found Conclusion prostatic observed group histopathologically be harboring data suggest managed using These warrant large, controlled, prospective further lower rate.