Detection of clinically significant prostate cancer in biopsy‐naïve men: direct comparison of systematic biopsy, multiparametric MRI‐ and contrast‐ultrasound‐dispersion imaging‐targeted biopsy

Objectives To compare and evaluate a multiparametric magnetic resonance imaging (mpMRI)‐targeted biopsy (TBx) strategy, contrast‐ultrasound‐dispersion imaging (CUDI)‐TBx strategy and systematic biopsy (SBx) strategy for the detection of clinically significant prostate cancer (csPCa) in biopsy‐naïve men. Patients and Methods A prospective, single‐centre paired diagnostic study included 150 biopsy‐naïve men, from November 2015 to November 2018. All men underwent pre‐biopsy mpMRI and CUDI followed by a 12‐core SBx taken by an operator blinded from the imaging results. Men with suspicious lesions on mpMRI and/or CUDI also underwent MRI‐TRUS fusion‐TBx and/or cognitive CUDI‐TBx after SBx by a second operator. A non‐inferiority analysis of the mpMRI‐ and CUDI‐TBx strategies in comparison with SBx for International Society of Urological Pathology Grade Group [GG] ≥2 PCa in any core with a non‐inferiority margin of 1 percentage point was performed. Additional analyses for GG ≥2 PCa with cribriform growth pattern and/or intraductal carcinoma (CR/IDC), and GG ≥3 PCa were performed. Differences in detection rates were tested using McNemar’s test with adjusted Wald confidence intervals. Results After enrolment of 150 men, an interim analysis was performed. Both the mpMRI‐ and CUDI‐TBx strategies were inferior to SBx for GG ≥2 PCa detection and the study was stopped. SBx found significantly more GG ≥2 PCa: 39% (56/142), as compared with 29% (41/142) and 28% (40/142) for mpMRI‐TBx and CUDI‐TBx, respectively (P