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MP74-13 A PROSPECTIVE VALIDATION OF THE DIAGNOSTIC ACCURACY OF PRI-MUS FOR PROSTATE CANCER RISK IDENTIFICATION

INTRODUCTION AND OBJECTIVES: The PRI-MUSTM (Prostate Risk Identification for Micro-Ultrasound) protocol was developed in 20161 to identify suspicious areas seen by the ExactVuTM micro-ultrasound imaging platform. Since its development, multiple clinical trials and studies have demonstrated the utility of the PRI-MUS protocol for targeted prostate biopsy, however little prospective validation data on overall accuracy has been reported. METHODS: 142 subjects were biopsied using the ExactVu micro-ultrasound system (Exact Imaging, Markham, Canada) from January to May 2018 at the Ordensklinikum Linz (Linz, Austria) with PSA scores ranging from 0.55 to 178.05 ng/mL and varying DRE results. Suspicious areas were assessed in real-time using PRI-MUS and a TRUS biopsy was performed in the same session under micro-ultrasound guidance. A total of 143 biopsies were completed by 5 providers (1 subject underwent 2 biopsy procedures). Results from pathology were then compared with the image findings. RESULTS: Biopsy pathology confirmed a cancer diagnosis in 79/142 (56%) of the subjects. 48/79 (60%) subjects had clinically significant cancer with a Gleason sum of 7 or higher. The PRI-MUS protocol had an area under the receiver-operator characteristic (AUC) of 0.79, with 100% sensitivity, 30% specificity and 100% negative predictive value for clinically significant cancer. As has been noted in other studies, PRI-MUS was more accurate for clinically significant cancer than for all cancer, demonstrating 0.69 AUC, 92% sensitivity, 30% specificity and a 76% negative predictive value for all cancer. CONCLUSIONS: Micro-ultrasound and the PRI-MUS protocol are useful tools to detect cancer and are more accurate in the detection of clinically significant cancer. This technology holds promise for reducing the high false-negative rate of prostate biopsy, without relying on multi-modality, multi-specialty solutions like mpMRI. 1. Ghai S, Eure G, Fradet V, et al. Assessing Cancer Risk on Novel 29 MHz Micro-Ultrasound Images of the Prostate: Creation of the Micro-Ultrasound Protocol for Prostate Risk Identification. J Urol. 2016;196(2):562-569. doi:10.1016/j.juro.2015.12.093 Source of Funding: none