Predictive clinical features for negative histopathology of MRI/ Ultrasound-fusion-guided prostate biopsy in patients with high likelihood of cancer at prostate MRI: Analysis from a urologic outpatient clinic1

OBJECTIVE: The aim of this study was to evaluate clinical features associated with benign histopathology of falsely classified Prostate Imaging Reporting and Data System (PI-RADS) category 4 and 5 lesions. MATERIALS AND METHODS: Between March 2015 and November 2020, 1161 patients underwent mpMRI/Ultrasound-fusion-guided prostate biopsy (FBx) and concurrent 12-core systematic prostate biopsy (SBx) at the Department of Urology of the Ludwig-Maximilian-University of Munich, Germany. 848/ 1161 (73%) patients presented with either PI-RADS 4 or 5 index lesion and were retrospectively evaluated. Multivariate analysis was performed to evaluate clinical parameters associated with a negative outcome of PI-RADS 4 or 5 category lesions after FBx. Area under the receiver operating characteristics (ROC) curve (AUC) was conducted using ROC-analysis. RESULTS: 676/848 (79.7%) patients with either PI-RADS 4 or 5 index lesion were diagnosed with prostate cancer (PCa) by FBx and 172/848 (20.3%) patients had a negative biopsy (including the concurrent systematic prostate biopsy), respectively. Prostate volume (P-Vol) (OR 0.99, 95% CI = 0.98–1.00, p = 0.038), pre-biopsy-status (OR 0.48, 95% CI = 0.29–0.79, p = 0.004) and localization of the lesion in the transitional zone (OR 0.28, 95% CI = 0.13–0.60, p = 0.001) were independent risk factors for a negative outcome of FBx. Age (OR 1.09, 95% CI = 1.05–1.13, p < 0.001) and PSA density (PSAD) (OR 75.92, 95% CI = 1.03–5584.61, p = 0.048) increased the risk for PCa diagnosis after FBx. The multivariate logistic regression model combining all clinical characteristics achieved an AUC of 0.802 (95% CI = 0.765–0.835; p < 0.001) with a sensitivity and specificity of 66% and 85%. CONCLUSION: Falsely positive described lesions with high or highly likelihood of PCa on multiparametric magnetic resonance imaging (mpMRI) occur in a small amount of patients. Localization of the lesion in the transitional zone, prostate volume and prebiopsy were shown to be predictors for benign histopathology of category 4 or 5 lesions on mpMRI. Integration of these features into daily clinical routine could be used for risk-stratification of these patients after negative biopsy of PI-RADS 4 or 5 index lesions.