Multiparametric MRI SelectMDx Accuracy in the Diagnosis of Clinically Significant PCa in Men Enrolled in Active Surveillance.

BACKGROUND/AIM: To evaluate the diagnostic accuracy of the urinary SelectMDx test in the diagnosis of clinically significant prostate cancer (csPCa) in men enrolled in an active surveillance (AS) protocol.

PATIENTS AND METHODS

From July 2015 to July 2018, 125 men with very low-risk PCa were enrolled in the AS protocol; all patients underwent confirmatory transperineal saturation biopsy (SPBx). In the presence of PI-RADS score ≥3, a targeted MRI/TRUS fusion-guided biopsy was added to SPBx. Post-digital rectal examination urine was collected in 45/125 (36%) patients before SPBx; the genetic urine analysis was performed using a biomarker-based risk score model, the SelectMDx, that measured mRNA levels of distal-less homeobox 1 (DLX1) and homeobox C6 (HOXC6).

RESULTS

A total of 9/45 (20%) patients were reclassified as csPCa (7 cases=Grade Group 2; 2 cases=Grade Group 3); sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of mpMRI vs. SelectMDx in the diagnosis of csPCa were equal to 66.6 vs. 55.6%, 87.7 vs. 65.8%, 54.5 vs. 27.8%, 92.3 vs. 87%, 84.9 vs. 70.3%, respectively.

CONCLUSION

SPBx combined with MRI/TRUS fusion biopsy significantly outperformed the diagnostic accuracy of SelectMDx (70.3%) in the diagnosis of csPCa in men enrolled in AS.