Reza Sari Motlagh1,2, Takafumi Yanagisawa1,3, Tatsushi Kawada1,4, Ekaterina Laukhtina1,5, Pawel Rajwa1,6, Abdulmajeed Aydh1,7, Frederik König1,8, Maximilan Pallauf1,9, Nicolai A Huebner1,10, Pascal A Baltzer1,11, Pierre I Karakiewicz12, Axel Heidenreich1,13, Shahrokh F Shariat14,15,16,17,18,19,20. 1. Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria. 2. Men's Health and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 3. Department of Urology, The Jikei University School of Medicine, Tokyo, Japan. 4. Department of Urology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan. 5. Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia. 6. Department of Urology, Medical University of Silesia, Zabrze, Poland. 7. Department of Urology, King Faisal Medical City, Abha, Saudi Arabia. 8. Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 9. Department of Urology, University Hospital Salzburg, Paracelsus Medical University Salzburg, Salzburg, Austria. 10. Working Group for Diagnostic imaging in Urology (ABDU), Austrian association of Urology (ÖGU), Vienna, Austria. 11. Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Vienna, Austria. 12. Cancer Prognostics and Health outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada. 13. Department of Urology, University Hospital Cologne, Cologne, Germany. 14. Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria. shahrokh.shariat@meduniwien.ac.at. 15. Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia. shahrokh.shariat@meduniwien.ac.at. 16. Department of Urology, Weill Cornell Medical College, New York, NY, USA. shahrokh.shariat@meduniwien.ac.at. 17. Department of Urology, University of Texas Southwestern, Dallas, TX, USA. shahrokh.shariat@meduniwien.ac.at. 18. Department of Urology, Second Faculty of Medicine, Charles University, Prague, Czech Republic. shahrokh.shariat@meduniwien.ac.at. 19. Karl Landsteiner Institute of Urology and Andrology, Vienna, Austria. shahrokh.shariat@meduniwien.ac.at. 20. Hourani Center for Applied Scientific Research, Al-Ahliyya Amman University, Amman, Jordan. shahrokh.shariat@meduniwien.ac.at.
Abstract
BACKGROUND: The SelectMDx test is a promising biomarker that is developed based on detecting urinary messenger RNA in combination with clinical prostate cancer (PCa) risk factors. We aimed to compare SelectMDx and mpMRI as a diagnostic test in detecting PCa and high grade(HG)-PCa in men suspected to have PCa. METHODS: According to PRISMA, a systematic search was performed using major web databases for studies published before September 30, 2021. Studies that compared sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of SelectMDx and/or mpMRI were included. The bivariate random model that plotted sensitivity, specificity, PPV, NPV, and likelihood ratio (LR) for PCa and HG-PCa detection was applied to compare SelectMDx, mpMRI, and combination strategies (both positive and one or both positive). RESULTS: Seven studies comprising 1328 patients who had undergone SelectMDx and mpMRI to detect PCa were included. Regarding PCa detection, SelectMDx had a pooled sensitivity of 81%, specificity of 69.8%, PPV of 64.7%, NPV of 85%, and LRs of +2.68 to -0.27, while mpMRI had a pooled sensitivity of 80.8%, specificity of 73.4%, PPV of 72.4%, NPV of 83.5%, and LRs of +3.03 to -0.26. The one or both positive strategy had the highest sensitivity (96.3%), NPV (95.7%), and the lowest -LR (0.06). While the both positive strategy had the highest specificity (80.9%), the PPV (76.5%) and +LR (3.68). In the scenario of PI-RADS 3 lesions not being biopsied in case of a negative SelectMDx (n = 44), unnecessary biopsies would be reduced by 42% (44/105) while the risk of missing HG-PCa would be 9% (4/44). CONCLUSION: The performance of SelectMDx is comparable to that of mpMRI with regards to PCa and HG-PCa detection. In addition, this biomarker could help refine the clinical decision-making regarding the necessity of a biopsy in patients suspected to has been PCa.
BACKGROUND: The SelectMDx test is a promising biomarker that is developed based on detecting urinary messenger RNA in combination with clinical prostate cancer (PCa) risk factors. We aimed to compare SelectMDx and mpMRI as a diagnostic test in detecting PCa and high grade(HG)-PCa in men suspected to have PCa. METHODS: According to PRISMA, a systematic search was performed using major web databases for studies published before September 30, 2021. Studies that compared sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of SelectMDx and/or mpMRI were included. The bivariate random model that plotted sensitivity, specificity, PPV, NPV, and likelihood ratio (LR) for PCa and HG-PCa detection was applied to compare SelectMDx, mpMRI, and combination strategies (both positive and one or both positive). RESULTS: Seven studies comprising 1328 patients who had undergone SelectMDx and mpMRI to detect PCa were included. Regarding PCa detection, SelectMDx had a pooled sensitivity of 81%, specificity of 69.8%, PPV of 64.7%, NPV of 85%, and LRs of +2.68 to -0.27, while mpMRI had a pooled sensitivity of 80.8%, specificity of 73.4%, PPV of 72.4%, NPV of 83.5%, and LRs of +3.03 to -0.26. The one or both positive strategy had the highest sensitivity (96.3%), NPV (95.7%), and the lowest -LR (0.06). While the both positive strategy had the highest specificity (80.9%), the PPV (76.5%) and +LR (3.68). In the scenario of PI-RADS 3 lesions not being biopsied in case of a negative SelectMDx (n = 44), unnecessary biopsies would be reduced by 42% (44/105) while the risk of missing HG-PCa would be 9% (4/44). CONCLUSION: The performance of SelectMDx is comparable to that of mpMRI with regards to PCa and HG-PCa detection. In addition, this biomarker could help refine the clinical decision-making regarding the necessity of a biopsy in patients suspected to has been PCa.