A Novel Urine Exosome Gene Expression Assay to Predict High-grade Prostate Cancer at Initial Biopsy

摘要: Importance Overdiagnosis and overtreatment of indolent prostate cancer (PCA) is a serious health issue in most developed countries. There an unmet clinical need for noninvasive, easy to administer, diagnostic assays help assess whether biopsy warranted. Objective To determine the performance novel urine exosome gene expression assay (the ExoDx Prostate IntelliScore assay) plus standard care (SOC) (ie, prostate-specific antigen [PSA] level, age, race, family history) vs SOC alone discriminating between Gleason score (GS)7 GS6 benign disease on initial biopsy. Design, Setting, Participants In training, using reverse-transcriptase polymerase chain reaction (PCR), we compared with outcomes 499 patients (PSA) levels 2 20 ng/mL. The derived prognostic was then validated 1064 from 22 community practice academic urology clinic sites United States. Eligible participants included PCA-free men, 50 years or older, scheduled repeated needle due suspicious digital rectal examination (DRE) findings and/or PSA (limit range, 2.0-20.0 ng/mL). Main Outcomes Measures Evaluate area under receiver operating characteristic curve (AUC) discrimination GS7 greater Results 255 men training target population (median age 62 median level 5.0 ng/mL, biopsy), associated improved disease: AUC 0.77 (95% CI, 0.71-0.83) 0.66 0.58-0.72) ( P Conclusions Relevance This urinary 3-gene that discriminates high-grade (≥GS7) low-grade (GS6) disease. this study, identification higher-grade among elevated could reduce total number unnecessary biopsies.