Prostate Cancer (PCa) is the most commonly diagnosed cancer and the second leading cause of cancer related deaths in men. Major issues associated with PSA testing for the initial diagnosis of PCa are: 1- the absence of a cut-off value associated with high specificity and sensitivity, and 2- PSA is organ but not cancer-specificit SelectMDx is a non-invasive post-digital rectal (DRE) urine methylation assay available in clinical practice to improve patient selection for initial prostate biopsy. A validated urinary 3 genes panel (HOXC6, TDRD1 and DLX1) showed high accuracy (AUC =0.77) for the detection of clinically significant (csPCa) compared with PSA and PCA3 test
Aim of the present study is to prospectively evaluate and compare performance of SelectMDx, total PSA and multiparametric magnetic resonance (mpMRI) of the prostate in men candidate for prostate biopsy.
Primary Objective:- To determine the dignostic performance as area under the curve (AUC), sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of SelectMDx in comparison with total PSA and mpMRI in predicting PCa and clincial significant (csPCa) at biopsy.Expected results : - In patients with clinical suspicious of PCa we can expect a positive SelectMDx score for patients with PCa at biopsy, while a negative SelectMDx score in negative biopsies. - SelectMDx may be a more specific biomarker for csPCa tham total PSA,
This is a prospective study. 100 men scheduled for prostate biopsy, based on elevated total PSA level (>3 ng/ml confirmed) or abnormal DRE, will be consecutively enrolled
mpMRI- All subjects included into the analysis will be submitted to a mpMRI using a 3 Tesla MR scanner (GE Discovery MR750).
SelectMDx. - First-voided urine samples (approximately 30 ml) will be collected after a standardized DRE, consisting of three stroke per lobe.
