Objective: Evaluating the predictive factors that enable identifying men in which a sole MRI/ultrasound (MRI/US) fusion-guided targeted biopsy (TB) detects the maximal prostate cancer (PCa) risk group. Patients and Methods: Retrospective analysis of 251 consecutive patients who received a sensor-based, real-time MRI/US TB in combination with a 10-core systematic biopsy (SB) between August 2013 and July 2015. Univariate and multivariate binary regression analyses were performed to evaluate the predictors for equal/superior detection of the PCa risk group by TB compared to SB. Results: TB detected PCa in 63% (157/251); SB detected PCa in 70% (176/251); a combination of TB and SB detected PCa in 77% (193/251) of cancer patients. Fifty percent (291/584) of TB cores and 22% (539/2,486) of SB cores showed PCa. Predictors for equal/superior performance of a sole TB were lesion size (maximal diameter; OR 1.050, 95% CI 1.002-1.101, p = 0.043), suspicious digital rectal examination (DRE; OR 2.448, 95% CI 1.062-5.645, p = 0.036) and free/total prostate-specific antigen (PSA) ratio (f/t PSA ratio) ≤0.15 (OR 0.916, 95% CI 0.867-0.967, p = 0.002) on univariate regression analysis and f/t PSA ratio ≤0.15 (OR 0.916, 95% CI 0.867-0.967, p = 0.002) on multivariate regression analysis. Conclusion: The maximal axial diameter of the Prostate Imaging Reporting and Data System-lesion and f/t PSA ratio and a suspicious DRE are possible selection criteria for men eligible for a sole MRI/US fusion-guided targeted prostate biopsy.

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