The Clinical Impact of the 4Kscore Test on Prostate Biopsy Decision Making in the Setting of MRI

Introduction: Biomarkers are often used in conjunction with MRI to improve the specificity of prostate cancer screening. Our objective was to evaluate the real-world utility of the 4Kscore test in the setting of MRI. We explored the association of the 4Kscore test with the decision to pursue prostate biopsy and its contribution to the accurate detection of clinically significant prostate cancer. Methods: We retrospectively analyzed patients undergoing the 4Kscore test and MRI for consideration of prostate biopsy. Multivariable logistic regression was used to model the association of 4Kscore with the decision to pursue biopsy. Receiver-operating characteristic curves were used to calculate the AUC of 4Kscore alone, PSA with MRI, and 4Kscore with MRI for detection of Gleason Grade Group ≥ 2 (GG ≥ 2) prostate cancer. Results: Of 442 patients, 311 (70%) proceeded to biopsy. 4Kscore was associated with the decision to pursue biopsy for continuous (odds ratio [OR] 1.05 per 1-point increase in 4Kscore, 95% confidence interval [CI] 1.02-1.07; P < .001) and categorical (high-risk 4Kscore: OR 16.1, 6.62-39.3, P < .001; intermediate-risk 4Kscore: OR 6.89, 95% CI 3.15-15.1; P < .01) models. For the detection of GG ≥ 2 prostate cancer, the AUC of 4Kscore with MRI (AUC = 0.866) was superior to 4Kscore alone (AUC = 0.800, P < .001) and PSA with MRI (AUC = 0.792, P < .001). Conclusions: In patients with MRI, the 4Kscore is associated with the decision to pursue prostate biopsy and augments the accurate prediction of GG ≥ 2 prostate cancer. Our findings suggest 4Kscore provides independent information as an adjunct to MRI for real-world clinical decision making.