Accuracy of real‐time magnetic resonance imaging‐transrectal ultrasound fusion image‐guided transperineal target biopsy with needle tracking with a mechanical position‐encoded stepper in detecting significant prostate cancer in biopsy‐naïve men

<jats:sec><jats:title>Objective</jats:title><jats:p>To evaluate the accuracy of real‐time elastic fusion image‐guided transperineal prostate biopsy with needle tracking involving a mechanical position‐encoded stepper in detecting clinically significant prostate cancer for biopsy‐naïve men.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We prospectively recruited patients with serum prostate‐specific antigen levels of 4.0–20 ng/mL and suspicious of prostate cancer on multiparametric magnetic resonance imaging. They underwent targeted biopsies for cancer‐suspicious lesions and 12‐core systematic biopsies. Pathological findings from biopsy cores and whole‐mount specimens (for those who underwent radical prostatectomy) were analyzed.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>A total of 250 patients were included, in whom targeted and systematic biopsies detected significant cancers in 55% and 25%, respectively (<jats:italic>P</jats:italic> < 0.001). The targeted biopsy cores (<jats:italic>n</jats:italic> = 527) showed significantly greater biopsy‐proven significant cancer detection rates (<jats:italic>P</jats:italic> < 0.001), cancer core length (<jats:italic>P</jats:italic> < 0.0001), cancer core percentage (<jats:italic>P</jats:italic> < 0.001) and Gleason scores (<jats:italic>P</jats:italic> < 0.001) than did the systematic biopsies. The significant cancer detection rate for targeted lesions (those with Prostate Imaging and Reporting and Data System classification scores of 5) was 80%. Biopsy‐proven significant cancer detection rates for targeted lesions ≤10 mm and >10 mm were similar for Prostate Imaging and Reporting and Data System scores of 4 (<jats:italic>P</jats:italic> = 0.707) and 5 (<jats:italic>P</jats:italic> = 0.386). In whole‐mount specimens (<jats:italic>n</jats:italic> = 30), locations for 95% of significant cancers were diagnosed preoperatively. Targeted biopsies alone diagnosed 79% of significant cancers.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Although targeted biopsies are superior to systematic biopsies in detecting significant cancers, systematic biopsies maintain an important role in the diagnosis of prostate cancer in biopsy‐naïve men.</jats:p></jats:sec>