Objective: To investigate the diagnostic role of magnetic resonance imaging (MRI)-targeted biopsy (TB) for prostate cancer (PCa) in biopsy-naïve men. Materials and Methods: Own control studies and randomized controlled trials (RCTs) up to December 2018 were identified via a systematic search of PubMed, Embase, Ovid, and the Cochrane Library. We pooled relative sensitivity (or risk ratio [RR]) to compare diagnostic efficiency for PCa and clinically significant PCa (csPCa) between TB and systematic biopsy (SB). The independent role of either biopsy pathway was evaluated for participants with positive/negative MRI. Results: Thirty-one studies consisting of 25 own control studies and 6 RCTs were included. We identified 4,020 biopsy-naïve men with positive MRI who underwent two biopsies concurrently, with PCa/csPCa detection rates of 65.90 and 45.13%, respectively. TB and SB did not differ in the detection of any PCa (RR 0.98, 95% confidence interval [CI] 0.92–1.05). However, TB detected more csPCa (RR 1.19, 95% CI 1.10–1.30) and more PCa with a Gleason score ≥3+4 (RR 1.20, 95% CI 1.07–1.34). Using a combined test as a reference, omitting SB resulted in detecting 12.81% less csPCa and 20.76% less clinically insignificant PCa (cinsPCa), and omitting TB resulted in detecting 25.69% less csPCa and 10.8% more cinsPCa. For patients with negative MRI, omitting SB led to underdetection of 30.29% of any PCa (10.9% of csPCa). Conclusions: Combining TB and SB increased the diagnostic accuracy of csPCa for biopsy-naïve men with positive MRI, and omitting SB for patients with a negative MRI would lead to the underdetection of nearly 10% of csPCa.

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