Abstract

ObjectivesTo compare the detection rate of clinically significant prostate cancer (csPC) and prostate cancer and to find out the diagnostic concordance between microultrasound (mUS), a high-resolution imaging system that can identify suspicious prostate lesions and biopsy them in real time, and multiparametric magnetic resonance imaging (mpMRI)-guided prostate fusion biopsies. MethodsA prospective, multicentre, single-blind, single cohort study was conducted involving 80 patients with clinically suspected prostate cancer who underwent concomitant mpMRI-guided fusion prostate biopsy (KoelisTM System) and microultrasound-guided biopsy (ExactVuTM System) Results:The detection rate of csPC was slightly higher for image-guided fusion biopsy (21.25% vs. 18.75%), but this difference was not statistically significant (p=0.453). There was also no significant difference in overall PC diagnosis (50% vs. 51.25%, p = 0.897). The degree of agreement between the two diagnostic techniques for the detection of csPC as assessed by Cohen's Kappa concordance index was satisfactory κ ̂ = 0.676. The degree of ISUP of targeted biopsies obtained from concordant lesions was also represented by satisfactory concordance with a Kappa index of κ ̂ = 0. 696. ConclusionsMicroultrasound-guided biopsy is presented as an effective diagnostic method for the diagnosis of csPC compared to image-guided fusion biopsy. No differences are found in the detection rates of csPC and PC between the two strategies and satisfactory concordance is found in terms of histopathological findings.

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