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. Copyright
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. Copyright
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