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MP13-09 NOVEL COMBINATION OF CIRCULATING MIRNAS FOR SPECIFIC DETECTION IN PROSTATE CANCER

INTRODUCTION AND OBJECTIVES: Prostate cancer (PCa) screening mainly relies on prostate-specific antigen (PSA). However, the lack of specificity of PSA testing leads to an unnecessary biopsy. Indeed, although the United States Preventive Services Task Force (USPSTF) assigned a grade of C to PSA-based screening for men aged 55 to 69 years, the USPSTF recommends against PSA-based screening for men ≥70 years. The presence of circulating miRNA can potentially offer crucial information about cancerous conditions in a less-invasive manner. In this study, we aimed to establish a model based on a combination of circulating miRNAs to detect PCa in men with suspected PCa with high sensitivity and specificity by using large-scale miRNA microarray analyses. METHODS: To develop an optimal diagnostic model, we examined comprehensive miRNA profiles of 809 serum samples of PCa patients, 241 of negative prostate biopsy patients and 41 of healthy controls using microarray. We divided them into 3 groups, discovery set (N=82), training set (N=484) and validation set (N=484). The discovery set was used to identify candidate miRNAs for PCa detection, and the training set was used to construct a diagnostic model using combinations of candidate miRNAs. Finally, the performance of the diagnostic model was evaluated in the validation set. RESULTS: In the discovery set, we identified 16 miRNAs that were upregulated, and 2 miRNAs that were downregulated in PCa samples. In training set, a robust diagnostic model was constructed based on expression level of two miRNAs in training set, and the diagnostic performance of it was validated in the validation set with a sensitivity of 0.90, a specificity of 0.90, and an area under the curve (AUC) of 0.95. In addition, regardless of the patients' stage, the diagnostic model showed high sensitivity. CONCLUSIONS: The present study is the largest scale study performed to date, and the results indicated that evaluation of circulating miRNAs is a feasible method for detecting PCa in men with suspected PCa. Our established model would help us improve the diagnosis of PCa and reduce unnecessary biopsy of the prostate. Source of Funding: “Development of Diagnostic Technology for Detection of miRNA in Body Fluids” grant from the Japan Agency for Medical Research and Development