Detection of clinically significant prostate cancer in biopsy-naive men: Head-to-head comparison of systematic biopsy, multiparametric MRI- and contrast ultrasound dispersion imaging-targeted biopsy.

OBJECTIVES: To compare and evaluate an 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 in biopsy-naive men. METHODS: A prospective, single center, paired diagnostic study included 150 biopsy-naive men (from November 2015 to November 2018). All men underwent pre-biopsy mpMRI and CUDI followed by a 12-core SBx performed by an operator blinded for imaging. 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-strategy and CUDI-strategy 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-strategy were inferior to SBx in 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 MRI-TBx and CUDI-TBx, respectively (p /= 2 PCa with CR/IDC and GG >/= 3 PCa did not differ significantly between the strategies. The mpMRI- and CUDI-strategy were comparable in detection but the mpMRI-strategy demonstrated less false-positive findings (18% vs. 53%). CONCLUSIONS: In our study in biopsy-naive men, the mpMRI- and CUDI-strategy demonstrated comparable PCa detection rates but the mpMRI-strategy showed less false-positive findings. Both strategies showed inferior detection for GG >/= 2 PCa in comparison with SBx, despite reduced detection of insignificant GG = 1 PCa. Both strategies did not significantly differ to SBx in the detection of GG >/= 2 PCa with CR/IDC and GG >/= 3 PCa.