Abstract

BackgroundTo determine the accuracy of a novel BIA test endorectal probe. MethodsOne hundred-forty consecutive patient candidates to prostate biopsy and 40 healthy volunteers were selected (NCT03428087). Total PSA and PSA density (PSAD) determinations, digital rectal examination (DRE), and the BIA test were analysed in patients and controls. A 16 cores trans rectal prostate biopsy was performed on all patients with clinical suspicion of PCa after a multiparametric MRI (mMRI) test. The study endpoints were to determine accuracy of BIA test in comparison to PSA, PSAD levels, and mMRI and obtain PCa prediction in candidates to prostate biopsy by BIA test. The Mann-Withney U test, the Wilkoxon rank test, and Holm-Bonferronis method were adopted for statistical analyses, and a computational approach was also applied to differentiate patients with PCa from those with benign disease (BPH). ResultsCombined DRE, TRUS, PSA, and PSAD alone failed to satisfactorily discern patients with PCa from those with BPH (62.86% of discrimination accuracy) and mMRI PIRADS [≥]3 showed a sensitivity of 83% and a specificity of 59%. The accuracy in discerning PCa and BPH increased up to 75% by BIA test (sensitivity 63.33% and specificity 83.75%). ConclusionsThe BIA test is a simple, promising, cheap, and reliable test for PCa non-invasive diagnosis. The novel finger probe may improve PCa detection also in patients with low-risk PCa, thus reducing the need of useless biopsies.