Introduction: High-resolution micro-ultrasound has the capability of imaging prostate cancer based on detecting alterations in ductal anatomy, analogous to multiparametric magnetic resonance imaging (mpMRI). This technology has the potential advantages of relatively low cost, simplicity, and accessibility compared to mpMRI. This multicenter, prospective registry aims to compare the sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) of mpMRI with high-resolution micro-ultrasound imaging for the detection of clinically significant prostate cancer. Methods: We included 1040 subjects at 11 sites in seven countries who had prior mpMRI and underwent ExactVu micro-ultrasound-guided biopsy. Biopsies were taken from both mpMRI targets (PI-RADS >3 and micro-ultrasound targets (PRIMUS >3). Systematic biopsies (up to 14 cores) were also performed. Various strategies were used for mpMRI target sampling, including cognitive fusion with micro-ultrasound, separate software-fusion systems, and software-fusion using the micro-ultrasound FusionVu system. Clinically significant cancer was those with Gleason grade group ≥2. Results: Overall, 39.5% were positive for clinically significant prostate cancer. Micro-ultrasound and mpMRI sensitivity was 94% vs. 90%, respectively (p=0.03), and NPV was 85% vs. 77%, respectively. Specificities of micro-ultrasound and MRI were both 22%, with similar PPV (44% vs. 43%). This represents the initial experience with the technology at most of the participating sites and, therefore, incorporates a learning curve. Number of cores, diagnostic strategy, blinding to MRI results, and experience varied between sites. Conclusions: In this initial multicenter registry, micro-ultrasound had comparable or higher sensitivity for clinically significant prostate cancer compared to mpMRI, with similar specificity. Micro-ultrasound is a low-cost, single-session option for prostate screening and targeted biopsy. Further larger-scale studies are required for validation of these findings.

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detection rate and pathological stratification of PCa using contextual SBx during MRI-TBx.METHODS: Patients previously submitted to negative-SBx (cohort A) and those enrolled in an AS program (cohort B) who showed at least one suspicious area with a PIRADSv2 score ³ 3 were prospectively and randomly assigned to only TBx strategy vs TBx plus SBx strategy. SBx locations could not encompass the TBx sites, so that the results of each type of biopsy was independent and did not overlap.RESULTS: A total of 312 patients were included in the two cohorts (cohort A: 213 cases; cohort B: 99 cases). No significant differences were found in terms of overall PCa-DR (77,6% vs 69,6% respectively; p[0,36) and csPCa-DR (48,2% vs 60,9% respectively; p[0,12). The MRI-TBx alone cohort showed higher csPCa/PCa ratio (87,5% vs 62,2%; p[0,03). The MRI-TBx plus SBx group subanalysis showed significantly higher csPCa-DR obtained at the MRI-TBx cores when compared to the SBx cores (43,7% vs 24,1%, respectively; p[0.01). Independently to age, PSA and PI-RADS score, either in re-biopsy (OR 0.43, 0.21 e 0.97) or AS (OR 0.46, 0.32 e 0.89) setting, SBx cores were negatively associated with the csPCa-DR when combined to TBx cores.CONCLUSIONS: MRI-TBx should be considered the elective method to perform prostate biopsy in patients with previous negative SBx and those considered for an AS program. Adding SBx samples to MRI-TBx didn't improvedetection rate of csPCa.

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