Prostate cancer detection in patients with total serum prostate-specific antigen levels of 4–10 ng/mL: Diagnostic efficacy of MicroRNA-141

Objective: The purpose of this small pilot study was to evaluate the utility of microRNA-141 (miR-141) as a biomarker for detecting prostate cancer (PCa) in patients with total serum prostate-specific antigen (PSA) levels of 4–10 ng/mL, which is referred to as the “gray zone.” Materials and Methods: Eleven PCa patients, 23 benign prostatic hyperplasia (BPH) patients with PSA levels of 4–10 ng/mL, and 16 healthy controls were enrolled in this study. Total RNA was extracted from serum samples, and the level of miR-141 was analyzed by quantitative reverse transcription polymerase chain reaction. Results: The circulating miR-141 level was significantly higher in PCa patients than in BPH patients and healthy controls (fold change [mean ± standard deviation], 0.528 ± 0.083 for PCa, 0.297 ± 0.038 for BPH, and 0.262 ± 0.025 for controls; P< 0.05). Receiver operating characteristic curve revealed that the serum miR-141 yielded an area under the curve of 0.751, with 72% sensitivity and 92% specificity in discriminating patients with PCa from BPH patients with total serum PSA levels in the gray zone. Conclusion: The present results indicate that miR-141 expression is significantly increased in the peripheral blood of patients with PCa compared with BPH patients and healthy individuals. We think that miR-141 may guide clinicians during the decision phase of patients with PCa and BPH in the PSA gray zone.