Validation of a new urine test for clinically significant prostate cancer

To reduce overdiagnosis and overtreatment there is an urgent need for a test to detect clinically significant prostate cancer (PCa). In this study a model was developed (using the identified biomarkers HOXC6, DLX1, TDRD1 and HOXC4) for the prediction of high-grade PCa upon prostate biopsy. In two prospective, multicenter studies (cohort A: n = 492; cohort B: n = 371) urine was collected prior to prostate biopsies. Results from cohort A were used to develop a model and validated in the independent cohort B. The HOXC6-DLX1 score resulted in the highest area under the curve of 0.76 (95%CI: 0.71–0.81), with 36 % specificity and 91 % sensitivity. The score was positively correlated with Gleason score. Subgroup analysis confirmed the value for patients with low PSA levels (< 10 ng/ml). The HOXC6-DLX1 score predicts the risk of high-grade PCa upon prostate biopsy. Using this urine test could reduce the amount of unnecessary biopsies, particularly in patients with low serum PSA levels. © 2016, Bohn Stafleu van Loghum.