Giovanni Lughezzani1, Davide Maffei2, Alberto Saita3, Marco Paciotti2, Pietro Diana2, Nicolò Maria Buffi2, Piergiuseppe Colombo4, Grazia Maria Elefante4, Rodolfo Hurle3, Massimo Lazzeri3, Giorgio Guazzoni2, Paolo Casale3. 1. Department of Urology, Humanitas Clinical and Research Center, Rozzano, Italy; Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan, Italy. Electronic address: Giovanni.lughezzani@hunimed.eu. 2. Department of Urology, Humanitas Clinical and Research Center, Rozzano, Italy; Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan, Italy. 3. Department of Urology, Humanitas Clinical and Research Center, Rozzano, Italy. 4. Department of Pathology, Humanitas Clinical and Research Center, Rozzano, Italy.
Abstract
BACKGROUND: Multiparametric magnetic resonance imaging (MRI) represents the gold standard for the diagnosis of clinically significant prostate cancer (csPCa). The search for alternative diagnostic techniques is still ongoing. OBJECTIVE: To determine the accuracy of microultrasound (microUS) for the diagnosis of csPCa within prospectively collected cohort of patients with a suspicion of prostate cancer (PCa) according to MRI. DESIGN, SETTING, AND PARTICIPANTS: A total of 320 consecutive patients with at least one Prostate Imaging Reporting and Data System (PIRADS) ≥3 lesion according to MRI were prospectively enrolled. INTERVENTION: All patients received microUS before prostate biopsy using the ExactVu system; the Prostate Risk Identification using microUS (PRI-MUS) protocol was used to identify targets. The urologists were blinded to MRI results until after the microUS targeting was completed. All patients received both targeted (based on either microUS or MRI findings) and randomized biopsies. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The sensitivity and specificity of microUS to determine the presence of csPCa (defined as at least one core with a Gleason score ≥7 PCa) were determined. Multivariable logistic regression analysis was fitted to determine the predictors of csPCa. RESULTS AND LIMITATIONS: Clinically significant PCa was diagnosed in 116 (36.3%) patients. The sensitivity and negative predictive value of microUS for csPCa diagnosis were 89.7% and 81.5%, while specificity and positive predictive value were 26.0% and 40.8%, respectively. A combination of microUS-targeted and randomized biopsies would allow diagnosing the same proportion of csPCa as that diagnosed by an approach combining MRI-targeted and randomized biopsies (n = 113; 97.4%), with only three (2.6%) csPCa cases diagnosed by a microUS-targeted and three (2.6%) by an MRI-targeted approach. In a logistic regression model, an increasing PRI-MUS score was an independent predictor of csPCa (p ≤ 0.005). The main limitation of the current study is represented by the fact that all patients had suspicious MRI. CONCLUSIONS: Microultrasound is a promising imaging modality for targeted prostate biopsies. Our results suggest that a microUS-based biopsy strategy may be capable of diagnosing the great majority of cancers, while missing only few patients with csPCa. PATIENT SUMMARY: According to our results, microultrasound (microUS) may represent an effective diagnostic alternative to magnetic resonance imaging for the diagnosis of clinically significant prostate cancer, providing high sensitivity and a high negative predictive value. Further randomized studies are needed to confirm the potential role of microUS in the diagnostic pathway of patients with a suspicion of prostate cancer.
BACKGROUND: Multiparametric magnetic resonance imaging (MRI) represents the gold standard for the diagnosis of clinically significant prostate cancer (csPCa). The search for alternative diagnostic techniques is still ongoing. OBJECTIVE: To determine the accuracy of microultrasound (microUS) for the diagnosis of csPCa within prospectively collected cohort of patients with a suspicion of prostate cancer (PCa) according to MRI. DESIGN, SETTING, AND PARTICIPANTS: A total of 320 consecutive patients with at least one Prostate Imaging Reporting and Data System (PIRADS) ≥3 lesion according to MRI were prospectively enrolled. INTERVENTION: All patients received microUS before prostate biopsy using the ExactVu system; the Prostate Risk Identification using microUS (PRI-MUS) protocol was used to identify targets. The urologists were blinded to MRI results until after the microUS targeting was completed. All patients received both targeted (based on either microUS or MRI findings) and randomized biopsies. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The sensitivity and specificity of microUS to determine the presence of csPCa (defined as at least one core with a Gleason score ≥7 PCa) were determined. Multivariable logistic regression analysis was fitted to determine the predictors of csPCa. RESULTS AND LIMITATIONS: Clinically significant PCa was diagnosed in 116 (36.3%) patients. The sensitivity and negative predictive value of microUS for csPCa diagnosis were 89.7% and 81.5%, while specificity and positive predictive value were 26.0% and 40.8%, respectively. A combination of microUS-targeted and randomized biopsies would allow diagnosing the same proportion of csPCa as that diagnosed by an approach combining MRI-targeted and randomized biopsies (n = 113; 97.4%), with only three (2.6%) csPCa cases diagnosed by a microUS-targeted and three (2.6%) by an MRI-targeted approach. In a logistic regression model, an increasing PRI-MUS score was an independent predictor of csPCa (p ≤ 0.005). The main limitation of the current study is represented by the fact that all patients had suspicious MRI. CONCLUSIONS: Microultrasound is a promising imaging modality for targeted prostate biopsies. Our results suggest that a microUS-based biopsy strategy may be capable of diagnosing the great majority of cancers, while missing only few patients with csPCa. PATIENT SUMMARY: According to our results, microultrasound (microUS) may represent an effective diagnostic alternative to magnetic resonance imaging for the diagnosis of clinically significant prostate cancer, providing high sensitivity and a high negative predictive value. Further randomized studies are needed to confirm the potential role of microUS in the diagnostic pathway of patients with a suspicion of prostate cancer.
Authors: Massimo Lazzeri; Vittorio Fasulo; Giovanni Lughezzani; Alessio Benetti; Giulia Soldà; Rosanna Asselta; Ilaria De Simone; Marco Paciotti; Pier Paolo Avolio; Roberto Contieri; Cesare Saitta; Alberto Saita; Rodolfo Hurle; Giorgio Guazzoni; Nicolò Maria Buffi; Paolo Casale Journal: Front Oncol Date: 2022-09-06 Impact factor: 5.738
Authors: Theresa H Lye; Omar Gachouch; Lisa Renner; Sefer Elezkurtaj; Hannes Cash; Daniel Messroghli; Kay Raum; Jonathan Mamou Journal: Ultrasound Med Biol Date: 2022-05-07 Impact factor: 3.694