Potential role of a novel urinary biomarker-based risk score to select patients for multiparametric MRI for prostate cancer detection.
Sources of Funding: MDxHealth
Introduction
Prostate cancer (PCa) diagnostics would greatly benefit from more accurate, non-invasive techniques for the detection of clinically significant disease, leading to a reduction of over-diagnosis and over-treatment. Multiparametric MRI (mpMRI) is being used increasingly and has proven to be a valuable addition to the PCa diagnostic pathway. A novel biomarker-based risk score (SelectMDx) assessing urinary HOXC6 and DLX1 mRNA expression levels combined with traditional clinical risk factors, was recently developed to predict high-grade PCa (Gleason score >/=7) upon prostate biopsy and to reduce the number of unnecessary biopsies. The aim of this study was to investigate the correlation between the risk score and mpMRI outcomes.
Methods
The patients in this retrospective observational cohort were previously included in the validation study of the SelectMDx risk score, in which urine was collected after digital rectal examination (DRE) from men undergoing prostate biopsies based on an elevated serum PSA level (>/=3.0 ng/ml) and/or suspicious DRE. A subset of patients underwent an mpMRI after prostate biopsies were performed (n=174). The indications for performing MRI were based on persistent clinical suspicion of PCa after negative prostate biopsies or staging after PCa was found upon biopsy.
Results
102 of 174 patients (59%) had PCa detected upon prostate biopsy, of which 54 (53%) had high-grade disease and a significantly higher SelectMDx risk score (p<0.001). The median SelectMDx risk score was also significantly higher in patients who had a suspicious lesion on MRI (p<0.001). For 81 mpMRI's the PIRADS classification was reported and there was a positive correlation observed between the risk score and the PIRADS classification (Figure 1). A Kruskal-Wallis test indicated a statistically significant difference in SelectMDx risk scores between the different PIRADS groups (p<0.001).
Conclusions
The novel urinary biomarker-based risk score is a promising tool in PCa detection. This study showed promising results regarding the correlation between the SelectMDx risk score with MRI outcomes. This risk score could potentially guide clinicians in selecting patients at risk for significant PCa for mpMRI.
Funding
MDxHealth
Leander Van Neste
Mulders Marloes
Jack A Schalken
Inge M Van Oort