Comparison of micro-ultrasound and multiparametric MRI imaging for prostate cancer: A multicenter prospective analysis.

Abstract

296 Background: This study aims to compare the sensitivity, specificity, NPV and PPV of mpMRI with the novel high-resolution micro-ultrasound imaging modality. This approach offers the benefits of simplicity, a single intervention for imaging and biopsy, leveraging the low cost of ultrasound. Micro-ultrasound may be used to image suspicious lesions and target biopsies in real-time with or without additional MRI-based targets. Methods: Data from 9 sites was aggregated, totaling 866 subjects presenting for ExactVu micro-ultrasound guided biopsy with available mpMRI studies. Samples in all subjects were taken from mpMRI targets and micro-ultrasound targets, with up to 12 systematic samples filled in. 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 considered any Gleason Sum > 6 and targeted samples were taken for PI-RADS > 2 or PRI-MUS1 > 2 lesions. Results: Overall, 39% of all biopsy cases were positive for clinically significant PCa. mpMRI demonstrated 89% sensitivity and NPV of 77%. Compared to mpMRI, micro-ultrasound sensitivity (95%) and NPV (87%) were higher. Micro-ultrasound was less specific (21% vs 23% for mpMRI) with similar PPV (44% vs 43%). The aggregate effect demonstrates higher sensitivity for csPCa with micro-ultrasound compared to mpMRI (p<0.01). Conclusions: Micro-ultrasound is an attractive option for screening and targeted biopsy. Sensitivity and NPV appear superior to MRI, but specificity is mildly reduced. Further larger-scale studies are required for validation of these findings.