Abstract

Multiparametric MRI (mpMRI) is commonly recommended as a triage test prior to any prostate biopsy. However, there exists limited consensus on which patients with a negative prostate mpMRI could avoid prostate biopsy. To identify which patient could safely avoid prostate biopsy when the prostate mpMRI is negative, via a radiomics-based machine learning approach. Retrospective. Three hundred thirty patients with negative prostate 3T mpMRI between January 2016 and December 2018 were included. A 3.0 T/T2-weighted turbo spin echo (TSE) imaging (T2 WI) and diffusion-weighted imaging (DWI). The integrative machine learning (iML) model was trained to predict negative prostate biopsy results, utilizing both radiomics and clinical features. The final study cohort comprised 330 consecutive patients with negative mpMRI (PI-RADS < 3) who underwent systematic transrectal ultrasound-guided (TRUS) or MR-ultrasound fusion (MRUS) biopsy within 6 months. A secondary analysis of biopsy naïve subcohort (n=227) was also conducted. The Mann-Whitney U test and Chi-Squared test were utilized to evaluate the significance of difference of clinical features between prostate biopsy positive and negative groups. The model performance was validated using leave-one-out cross-validation (LOOCV) and measured by AUC, sensitivity, specificity, and negative predictive value (NPV). Overall, 306/330 (NPV 92.7%) of the final study cohort patients had negative biopsies, and 207/227 (NPV 91.2%) of the biopsy naïve subcohort patients had negative biopsies. Our iML model achieved NPVs of 98.3% and 98.0% for the study cohort and subcohort, respectively, superior to prostate-specific antigen density (PSAD)-based risk assessment with NPVs of 94.9% and 93.9%, respectively. The proposed iML model achieved high performance in predicting negative prostate biopsy results for patients with negative mpMRI. With improved NPVs, the proposed model can be used to stratify patients who in whom we might obviate biopsies, thus reducing the number of unnecessary biopsies. 3 TECHNICAL EFFICACY: Stage 2.

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