Abstract

INTRODUCTION AND OBJECTIVE: mpMRI - targeted biopsy is increasing as a useful tool to improve accuracy of PCa detection. Micro-Ultrasound (Micro-US) is as a new high-resolution imaging system, allowing real time targeted biopsies. The aim is to assess transperineal prostate biopsy accuracy for PCa detection combining Micro-US and mpMRI fusion biopsy during the same procedure. METHODS: 200 consecutive patients underwent transperineal prostate biopsies combining real-time targeted Micro-US (ExactVuTM) biopsies and mpMRI fusion biopsy in the same procedure, from February 2018 - September 2019. Biopsies were performed by Urologists using the PRIMUSTM Scale and a 3D printed TP guide attached to the 29MHz High resolution Micro-US transducer. Parameters assessed included Age, PSA, prostate volume, MRI lesions, PCa, csPCa (ISUP > 1), Gleason Group Grade (GG) and complications according to Clavien Dindo. McNeamar test and a Logistic Regression Model were conducted, p ≤ 0.05 were considered statistically significant. RESULTS: Median patient age was 63 (IQR 58-69). The overall positive rate was 57.5 % (115) for PCa and 39.5 % (79) for csPCa, Micro-US and MRI together detected significantly more PCa and csPCa than systematic biopsy (p<0.001). mpMRI biopsies vs targeted micro-US did not reach statistical difference for PCa or csPCa diagnosis (p=0.24). Interestingly micro-US found 12/113 (11%) PCa that were missed by all other modalities and 11 (92%) were csPCa. Both PI-RADS and PRI-MUS are strong predictors of csPCa in Logistic Regression Model (AUC for model with leave-one-out validation = 0.7). Specifically, for PSA >4, PIRADS>3 there is an improvement in detection rate between PRI-MUS 4 and PRI-MUS 5 (36% GG>1 to 60% GG>1). No fever or clinical infection was observed in none patient, 18 (9%) patients presented minor complications (Clavien Dindo I). CONCLUSIONS: This is the first study using transperineal approach for prostate biopsies combining Micro-ultrasound and mpMRI fusion biopsy. Results show high accuracy for PCa and csPCA diagnosis, without infectious complications due to biopsy. The proposed method should be validated in large randomized clinical trials.Source of Funding: None

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