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

Published: June 28, 2021
Abstract Views: 1641
PDF: 857
Publisher's note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

Authors

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.

Dimensions

Altmetric

PlumX Metrics

Downloads

Download data is not yet available.

Citations

Ferlay J, Soerjomataram I, Dikshit R, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015; 136:E359. DOI: https://doi.org/10.1002/ijc.29210
Ahmed HU, El-Shater Bosaily A, Brown LC, et al. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017; 389:815-822. DOI: https://doi.org/10.1016/S0140-6736(16)32401-1
D'Agostino D, Mineo Bianchi F, Romagnoli D, et al. MRI/TRUS FUSION guided biopsy as first approach in ambulatory setting: Feasibility and performance of a new fusion device. Arch Ital Urol Androl. 2020; 91:211-217. DOI: https://doi.org/10.4081/aiua.2019.4.211
Schiavina R, Borghesi M, Brunocilla E, et al. The biopsy Gleason score 3+4 in a single core does not necessarily reflect an unfavourable pathological disease after radical prostatectomy in comparison with biopsy Gleason score 3+3: looking for larger selection criteria for active surveillance candidates. Prostate Cancer Prostatic Dis. 2015; 18:270-5. DOI: https://doi.org/10.1038/pcan.2015.21
D'Agostino D, Mineo Bianchi F, Romagnoli D, et al. Comparison between "In-bore" MRI guided prostate biopsy and standard ultrasound guided biopsy in the patient with suspicious prostate cancer: Preliminary results. Arch Ital Urol Androl. 2019; 91:87-92. DOI: https://doi.org/10.4081/aiua.2019.2.87
Schiavina R, Vagnoni V, D'Agostino D, et al. "In-bore" MRI-guided prostate biopsy using an endorectal nonmagnetic device: a prospective study of 70 consecutive patients. Clin Genitourin Cancer. 2017; 15:417-427. DOI: https://doi.org/10.1016/j.clgc.2017.01.013
Hamoen EHJ, de Rooij M, Witjes JA, et al. Use of the Prostate Imaging Reporting and Data System (PI-RADS) for prostate cancer detection with multiparametric Magnetic Resonance Imaging: a diagnostic meta-analysis. Eur Urol. 2015; 67:1112-1121. DOI: https://doi.org/10.1016/j.eururo.2014.10.033
Kasivisvanathan V, Rannikko AS, Borghi M, et al. MRI-targeted or standard biopsy for prostate-cancer diagnosis. N Engl J Med. 2018; 378:1767-77. DOI: https://doi.org/10.1056/NEJMoa1801993
Schiavina R, Chessa F, Borghesi M, et al. State-of-the-art imaging techniques in the management of preoperative staging and restaging of prostate cancer. Int J Urol. 2019; 26:18-30. DOI: https://doi.org/10.1111/iju.13797
Pavlovich CP, Cornish TC; Mullins JK, et al. High-resolution transrectal ultrasound: pilot study of a novel technique for imaging clinically localized prostate cancer Urol Oncol. 2014; 32:34.e27-32. DOI: https://doi.org/10.1016/j.urolonc.2013.01.006
Halpern EJ, Frauscher F, Strup SE, et al. Prostate: high-frequency Doppler US imaging for cancer detection Radiology. 2002; 225:71-77. DOI: https://doi.org/10.1148/radiol.2251011938
Ghai S, Eure G, Fradet V. 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; 196:562-9. DOI: https://doi.org/10.1016/j.juro.2015.12.093
Lughezzani G, Saita A, Lazzeri M, et al. Comparison of the diagnostic accuracy of micro-ultrasound and magnetic resonance imaging/ultrasound fusion targeted biopsies for the diagnosis of clinically significant prostate cancer. Eur Urol Oncol. 2019; 2:329-332. DOI: https://doi.org/10.1016/j.euo.2018.10.001
Weinreb JC, Barentsz JO, Choyke PL, et al. PI-RADS prostate imaging—reporting and data system: 2015, version 2. Eur Urol. 2016; 69:16-40. DOI: https://doi.org/10.1016/j.eururo.2015.08.052
Schiavina R, Bianchi L, Borghesi M, et al. MRI displays the prostatic cancer anatomy and improves the bundles management before robot-assisted radical prostatectomy. J Endourol. 2018; 32:315-321. DOI: https://doi.org/10.1089/end.2017.0701
Antunes HP, Parada B, Carvalho J, et al. Prognostic value of subclassification (pT2 stage) of pathologically organ-confined prostate cancer: Confirmation of the changes introduced in the 8th edition of the American Joint Committee on Cancer (AJCC) staging system. Arch Ital Urol Androl. 2018; 90:191-194. DOI: https://doi.org/10.4081/aiua.2018.3.191
Barentsz JC, Richenberg J, Clements R, et al. ESUR prostate MR guidelines 2012 Eur Radiol. 2012; 22:746-757. DOI: https://doi.org/10.1007/s00330-011-2377-y
Epstein JI, Egevad L, Amin MB, et al. The 2014 International Society of Urological Pathology (ISUP) consensus conference on Gleason grading of prostatic carcinoma: definition of grading patterns and proposal for a new grading system. Am J Surg Pathol. 2016; 40:244-52. DOI: https://doi.org/10.1097/PAS.0000000000000530
Durkan GC, Sheikh N, Johnson P, et al. Improving prostate cancer detection with an extended-core transrectal ultrasonographyguided prostate biopsy protocol. BJU International. 2002; 89:33-39. DOI: https://doi.org/10.1046/j.1464-410X.2002.02555.x
Porreca A, D'Agostino D, Vigo M, et al. "In-bore" MRI prostate biopsy is a safe preoperative clinical tool to exclude significant prostate cancer in symptomatic patients with benign prostatic obstruction before transurethral laser enucleation. Arch Ital Urol Androl. 2020; 91:224-229. DOI: https://doi.org/10.4081/aiua.2019.4.224
Bertaccini A, Consonni P, Schiavina R, et al. Prostate biopsy: approaches Arch Ital Urol Androl. 2005; 77(3 Suppl 1):24-7.
Prayer-Galetti T, Ficarra V, Franceschini R. et al. When to carry out prostate biopsy Arch Ital Urol Androl. 2005; 77(3 Suppl 1):3-16.
Haffner J, Lemaitre L, Puech P, et al. Role of magnetic resonance imaging before initial biopsy: comparison of magnetic resonance imaging-targeted and systematic biopsy for significant prostate cancer detection. BJU Int. 2011; 108:E171-8. DOI: https://doi.org/10.1111/j.1464-410X.2011.10112.x
Kuru TH, Fütterer JJ, Schiffmann J, et al. Transrectal ultrasound (US), contrast-enhanced US, real-time elastography, histoscanning, magnetic resonance imaging (MRI), and MRI-US fusion biopsy in the diagnosis of prostate cancer. Eur Urol Focus. 2015; 1:117-126. DOI: https://doi.org/10.1016/j.euf.2015.06.003
Taverna G, Morandi G, Seveso M, et al. Colour Doppler and microbubble contrast agent ultrasonography do not improve cancer detection rate in transrectal systematic prostate biopsy sampling. BJU Int. 2011; 108:1723-7 DOI: https://doi.org/10.1111/j.1464-410X.2011.10199.x
Ghai S, Van der Kwast T. Suspicious findings on micro-ultrasound imaging and early detection of prostate cancer. Urol Case Rep. 2017; 16:98-100. DOI: https://doi.org/10.1016/j.eucr.2017.11.013
Schouten MG, van der Leest M, Pokorny M. Why and where do we miss significant prostate cancer with multi-parametric magnetic resonance imaging followed by magnetic resonance-guided and transrectal ultrasound-guided biopsy in biopsy-naïve men? Eur Urol. 2017; 71:896-903 DOI: https://doi.org/10.1016/j.eururo.2016.12.006

How to Cite

Chessa, F., Schiavina, R., Ercolino, A., Gaudiano, C., Giusti, D., Bianchi, L., Pultrone, C., Marcelli, E., Distefano, C., Lodigiani, L., & Brunocilla, E. (2021). 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. Archivio Italiano Di Urologia E Andrologia, 93(2), 132–138. https://doi.org/10.4081/aiua.2021.2.132