Francesco Chessa1, Riccardo Schiavina2, Amelio Ercolino3, Caterina Gaudiano4, Davide Giusti5, Lorenzo Bianchi6, Cristian Pultrone7, Emanuela Marcelli8, Concetta Distefano9, Luca Lodigiani10, Eugenio Brunocilla11. 1. Division of Urology, IRCCS Azienda Ospedaliero Universitaria di Bologna; Department of Urology, University of Bologna, S. Orsola-Malpighi University Hospital, Bologna. francesco.chessa@live.it. 2. Division of Urology, IRCCS Azienda Ospedaliero Universitaria di Bologna; Department of Urology, University of Bologna, S. Orsola-Malpighi University Hospital, Bologna. rschiavina@yahoo.it. 3. Division of Urology, IRCCS Azienda Ospedaliero Universitaria di Bologna. amelio.ercolino@studio.unibo.it. 4. Division of Radiology, IRCCS Azienda Ospedaliero Universitaria di Bologna. caterina.gaudiano@aosp.bo.it. 5. Division of Radiology, IRCCS Azienda Ospedaliero Universitaria di Bologna. davide.giusti@studio.unibo.it. 6. Division of Urology, IRCCS Azienda Ospedaliero Universitaria di Bologna; Department of Urology, University of Bologna, S. Orsola-Malpighi University Hospital, Bologna. lorenzo.bianchi13@unibo.it. 7. Division of Urology, IRCCS Azienda Ospedaliero Universitaria di Bologna; Department of Urology, University of Bologna, S. Orsola-Malpighi University Hospital, Bologna. cristian.pultrone@gmail.com. 8. Laboratory of Bioengineering, Department of Experimental Diagnostic and Specialty Medicine (DIMES), University of Bologna, Bologna. emanuela.marcelli@unibo.it. 9. Division of Urology, IRCCS Azienda Ospedaliero Universitaria di Bologna. CONCETTA.DISTEFANO@AOSP.BO.IT. 10. Product Manager AB Medica. lodigiani.luca@abmedica.it. 11. Division of Urology, IRCCS Azienda Ospedaliero Universitaria di Bologna; Department of Urology, University of Bologna, S. Orsola-Malpighi University Hospital, Bologna. eugenio.brunocilla@unibo.it.
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.
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.