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SelectMDx and Multiparametric Magnetic Resonance Imaging of the Prostate for Men Undergoing Primary Prostate Biopsy:
Martina Maggi1, Francesco Del Giudice1, Ugo G Falagario2
1Department of Urology, Sapienza Rome University, Policlinico Umberto I, 00161 Rome, Italy.
Abstract:
Prostate-specific antigen (PSA) testing as the sole indication for prostate biopsy lacks specificity, resulting in overdiagnosis of indolent prostate cancer (PCa) and missing clinically significant PCa (csPCa). SelectMDx is a biomarker-based risk score to assess urinary HOXC6 and DLX1 mRNA expression combined with traditional clinical risk factors. The aim of this prospective multi-institutional study was to evaluate the diagnostic accuracy of SelectMDx and its association with multiparametric magnetic resonance (mpMRI) when predicting PCa in prostate biopsies. Overall, 310 consecutive subjects were included. All patients underwent mpMRI and SelectMDx prior to prostate biopsy. SelectMDx and mpMRI showed sensitivity and specificity of 86.5% vs. 51.9%, and 73.8% vs. 88.3%, respectively, in predicting PCa at biopsy, and 87.1% vs. 61.3%, and 63.7% vs. 83.9%, respectively, in predicting csPCa at biopsy. SelectMDx was revealed to be a good predictor of PCa, while with regards to csPCa detection, it was demonstrated to be less effective, showing results similar to mpMRI. With analysis of strategies assessed to define the best diagnostic strategy to avoid unnecessary biopsy, SelectMDx appeared to be a reliable pathway after an initial negative mpMRI. Thus, biopsy could be proposed for all cases of mpMRI PI-RADS 4-5 score, and to those with Prostate Imaging-Reporting and Data System (PI-RADS) 1-3 score followed by a positive SelectMDx.
Insights
SelectMDx, a biomarker test, aids in prostate cancer (PCa) detection, improving diagnostic accuracy when combined with multiparametric magnetic resonance imaging (mpMRI). This strategy helps avoid unnecessary prostate biopsies by identifying high-risk patients effectively.
Area of Science:
- Urology
- Oncology
- Biomarker Research
Background:
- Prostate-specific antigen (PSA) testing alone leads to overdiagnosis of indolent prostate cancer (PCa) and missed clinically significant PCa (csPCa).
- SelectMDx is a novel biomarker risk score assessing urinary HOXC6 and DLX1 mRNA expression, combined with clinical factors, to improve PCa risk stratification.
Purpose of the Study:
- To prospectively evaluate the diagnostic accuracy of SelectMDx.
- To assess the association between SelectMDx and multiparametric magnetic resonance imaging (mpMRI) in predicting PCa and csPCa on prostate biopsy.
Main Methods:
- A prospective, multi-institutional study included 310 consecutive subjects undergoing both mpMRI and SelectMDx testing prior to prostate biopsy.
- Analysis focused on the sensitivity and specificity of SelectMDx and mpMRI in detecting PCa and csPCa.
Main Results:
- SelectMDx demonstrated high sensitivity (86.5%) and specificity (73.8%) for PCa detection, while mpMRI showed 51.9% sensitivity and 88.3% specificity.
- For csPCa detection, SelectMDx had 87.1% sensitivity and 61.3% specificity, comparable to mpMRI's 63.7% sensitivity and 83.9% specificity.
- SelectMDx proved effective in identifying PCa and showed potential as a reliable tool following a negative mpMRI.
Conclusions:
- SelectMDx is a valuable predictor of PCa, with performance for csPCa detection similar to mpMRI.
- A combined strategy of mpMRI (PI-RADS 4-5) and SelectMDx (for PI-RADS 1-3) can optimize diagnostic pathways and reduce unnecessary prostate biopsies.
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