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

Abstract

OBJECTIVE: The aim of this study was to evaluate clinical features associated with benign histopathology of 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-Maximilians-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: Lesions with high or highly likelihood of PCa on multiparametric magnetic resonance imaging (mpMRI) but subsequent negative prostate biopsy 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.

Magnetic Resonance Imaging, Clinical, and Biopsy Findings in Suspected Prostate Cancer

“…A total of 72 studies including 36 366 patients with suspected csPCa who underwent prostate MRI and subsequent biopsy were included (Figure 1). Details of the included study and patient characteristics are summarized in Table 1 and eTables 3 to 5 in Supplement 1. Studies were published between 2016 and 2022.…”

“…None of the included studies enrolled patients with prior csPCa. Among the 72 included studies, 19 solely included patients with low to moderate risk of csPCa (ie, PI-RADS≤3 and/or transitional zone index lesion and/or total PSA <10 ng/mL), 1 study solely included high-risk patients with PI-RADS 4 or greater, and the remaining 52 studies included all suspected patients regardless of the prostate MRI results or clinical parameters . The most frequently used imaging was 3.0 T (92.6%) and multiparametric MRI (80.3%).…”

“…Eight studies (11%) were judged to have a moderate risk of bias . No potential source of bias was identified for the other 64 (89%) studies .…”

“…Eight studies (11%) were judged to have a moderate risk of bias. 16,19,20,26,28,30,36,81 No potential source of bias was identified for the other 64 (89%) studies. [10][11][12][13][14][15]17,18,[21][22][23][24][25]27,29,[31][32][33][34][35] Retrospective study design and concern regarding the selection domain (ie, studies only noted that patients with suspected csPCa were included rather than providing detailed inclusion and/or exclusion criteria)…”

“…As such, ancillary clinical data have been proposed to complement MRI to minimize the number of unnecessary biopsies. This concept has been recently expanded by numerous studies, and several MRI-based risk models and strategies have been developed to guide decisions on prostate biopsy . However, it has been challenging to integrate the proposed approaches into clinical practice owing to considerable inconsistencies among them.…”