Clinical Utility of Negative Multiparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer and Clinically Significant Prostate Cancer.

Background: Multiparametric magnetic resonance imaging (MRI) is increasingly used to diagnose prostate cancer (PCa). It is not yet established whether all men with negative MRI (Prostate Imaging-Reporting and Data System version 2 score <3) should undergo prostate biopsy or not.

Objective: To develop and validate a prediction model that uses clinical parameters to reduce unnecessary prostate biopsies by predicting PCa and clinically significant PCa (csPCa) for men with negative MRI findings who are at risk of harboring PCa.

Design Setting And Participants: This was a retrospective analysis of 200 men with negative MRI at risk of PCa who underwent prostate biopsy (2014-2020) with prostate-specific antigen (PSA) >4 ng/ml, 4Kscore of >7%, PSA density ≥0.15 ng/ml/cm, and/or suspicious digital rectal examination. The validation cohort included 182 men from another centre (University of Miami) with negative MRI who underwent systematic prostate biopsy with the same criteria.

Outcome Measurements And Statistical Analysis: csPCa was defined as Gleason grade group ≥2 on biopsy. Multivariable logistic regression analysis was performed using coefficients of logit function for predicting PCa and csPCa. Nomogram validation was performed by calculating the area under receiver operating characteristic curves (AUC) and comparing nomogram-predicted probabilities with actual rates of PCa and csPCa.

Results And Limitations: Of 200 men in the development cohort, 18% showed PCa and 8% showed csPCa on biopsy. Of 182 men in the validation cohort, 21% showed PCa and 6% showed csPCa on biopsy. PSA density, 4Kscore, and family history of PCa were significant predictors for PCa and csPCa. The AUC was 0.80 and 0.87 for prediction of PCa and csPCa, respectively. There was agreement between predicted and actual rates of PCa in the validation cohort. Using the prediction model at threshold of 40, 47% of benign biopsies and 15% of indolent PCa cases diagnosed could be avoided, while missing 10% of csPCa cases. The small sample size and number of events are limitations of the study.

Conclusions: Our prediction model can reduce the number of prostate biopsies among men with negative MRI without compromising the detection of csPCa.

Patient Summary: We developed a tool for selection of men with negative MRI (magnetic resonance imaging) findings for prostate cancer who should undergo prostate biopsy. This risk prediction tool safely reduces the number of men who need to undergo the procedure.