Diagnostic accuracy of the Novel 29 MHz micro-ultrasound “ExactVuTM” for the detection of clinically significant prostate cancer: A prospective single institutional study. A step forward in the diagnosis of prostate cancer

Abstract

Introduction and Objective: ExactVuTM is a real-time micro-ultrasound system which provides, according to the Prostate Risk Identification Using Micro-Ultrasound protocol (PRI-MUS), a 300% higher resolution compared to conventional transrectal ultrasound. To evaluate the performance of ExactVuTM in the detection of Clinically significant Prostate Cancer (CsPCa). Materials and methods: Patients with Prostate Cancer diagnosed at fusion biopsy were imaged with ExactVuTM. CsPCa was defined as any Gleason Score ≥ 3+4. ExactVuTM examination was considered as positive when PRI-MUS score was ≥ 3. PRI-MUS scoring system was considered as correct when the fusion biopsy was positive for CsPCa. A transrectal fusion biopsy- proven CsPCa was considered as a gold standard. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and area under the receiver operator characteristic (ROC) curve (AUC) were calculated. Results: 57 patients out of 68 (84%) had a csPCa. PRI-MUS score was correctly assessed in 68% of cases. Regarding the detection of CsPCa, ExactVuTM ’s sensitivity, specificity, PPV, and NPV was 68%, 73%, 93%, and 31%, respectively and the AUC was 0.7 (95% CI 0.5-0-8). For detecting CsPCa in the transition/ anterior zone the sensitivity, specificity, PPV, and NPV was 45%, 66%, 83% and 25% respectively ant the AUC was 0.5 (95% CI 0.2-0.9). Accounting only the CsPCa located in the peripheral zone, sensitivity, specificity, PPV, and NPV raised up to 74%, 75%, 94%, 33%, respectively with AUC 0.75 (95% CI 0.5-0-9). Conclusions: ExactVuTM provides high resolution of the prostatic peripheral zone and could represent a step forward in the detection of CsPCa as a triage tool. Further studies are needed to confirm these promising results.

Microultrasound in the detection of the index lesion in prostate cancer

“…It employs high‐frequency waves of 29 MHz to achieve a resolution of 70 µm while remaining simple for operators to use. Despite being a recent addition to the field, preliminary findings indicate that MUS is as effective as mpMRI in detecting csPCa and extracapsular extension (ECE) 14–18 . Therefore, our study seeks to evaluate the accuracy of a transrectal MUS in identifying the IL in prostate cancer compared with mpMRI.…”

Saline‐assisted fascial exposure (SAFE) technique to improve nerve‐sparing in robot‐assisted laparoscopic radical prostatectomy

“…In fact, all the patients who underwent TR SAFE achieved negative surgical margins. This could be explained by the ability of the MUS to provide a real-time assessment of the tumour location and potential ECE [30][31][32][33][34], making it a valuable pre-and intraoperative tool. On the other hand, Elsayed et al analysed the superiority of a technique combining HD of the NVB with the preservation of puboprostatic ligaments, endopelvic fascia, and the dorsal venous complex.…”

“…In fact, all the patients who underwent TR SAFE achieved negative surgical margins. This could be explained by the ability of the MUS to provide a real‐time assessment of the tumour location and potential ECE [30–34], making it a valuable pre‐ and intraoperative tool.…”

Cost-effectiveness analysis of short biparametric magnetic resonance imaging protocol in men at risk of prostate cancer

“…Use of contrast enhanced transrectal ultrasound (CE-TRUS) was also proposed but, unlike liver or pancreatic lesions, contrast enhanced ultrasound is less suitable in Pca detection (29)(30)(31). The most common comparative diagnostic methods respect to MRI are TRUS, CE-TRUS and, more recently, micro-ultrasound; these methods can be better evaluated by a dedicated future study (32). Our study shows that BP-MRI effectively has a significant role detecting Pca; also, it could reasonably reduce the number of biopsies, thanks to its high sensitivity in identification and in localization of index lesions < 5 mm and < 7 mm (33).…”

“…Diagnosis and management of Pca can be implemented by multivariate stratification based on patient risk (PSA, DRE, age), associated with BP-MRI (scenario 2). Some trials show that stratifying patients can be a winning strategy to maximize benefits and reduce costs for both diagnosis and therapy (14,(29)(30)(31)(32)(33)(34)(35)(36)(37). An important implication of BP-MRI, however, regards the PIRADS assessment categories, as already well explained in PIRADS guidelines v2.1 (2).…”