Combination of PI-RADS score and mRNA urine test—A novel scoring system for improved detection of prostate cancer

Available tests to detect clinically significant prostate cancer frequently lead to overdiagnosis and overtreatment. Our study assessed the feasibility of combining a urinary biomarker-based risk score (SelectMDx.sup.®) and multiparametric MRI outcomes in order to identify patients with prostate can...

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Published inPloS one Vol. 17; no. 8; p. e0271981
Main Authors Katzendorn, Olga, von Klot, Christoph A. J, Mahjoub, Samy, Faraj Tabrizi, Pouriya, Harke, Nina N, Tezval, Hossein, Hellms, Susanne, Hennenlotter, Jörg, Baig, Mirza S, Stenzl, Arnulf, Seith, Ferdinand, Lafos, Marcel, Kuczyk, Markus A, Rausch, Steffen, Peters, Inga
Format Journal Article
LanguageEnglish
Published San Francisco Public Library of Science 12.08.2022
Public Library of Science (PLoS)
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Summary:Available tests to detect clinically significant prostate cancer frequently lead to overdiagnosis and overtreatment. Our study assessed the feasibility of combining a urinary biomarker-based risk score (SelectMDx.sup.®) and multiparametric MRI outcomes in order to identify patients with prostate cancer on prostate biopsy with increased accuracy and reliability. Samples of 74 men with suspicion of prostate cancer and available multiparametric MRI were analysed in a prospective cross-sectional study design. First-voided urine for determination of HOXC6 and DLX1 mRNA levels was collected after digital rectal examination and prior to MRI/ultrasound fusion-guided prostate biopsy. All multiparametric MRI images were centrally reviewed by two experienced radiologists blinded for urine test results and biopsy outcome. The PI-RADS v2 was used. SelectMDx.sup.® score, PI-RADS and Gleason Sore were obtained. Associations between Gleason Score, PI-RADS scores and SelectMDx.sup.® were assessed using ANOVA and t-test. Sensitivity and specificity were assessed and evaluated as area-under-the-curve of the receiver operating characteristic. Upon biopsy, 59.5% of patients were diagnosed with prostate cancer, whereby 40.6% had high-grade prostate cancer (GS [greater than or equal to] 7a). SelectMDx.sup.® scores were significantly higher for patients with positive biopsy findings (49.07 ± 25.99% vs. 22.00 ± 26.43%; p < 0.001). SelectMDx.sup.® scores increased with higher PI-RADS scores. Combining SelectMDx.sup.®, history of prior biopsy with benign histology and PI-RADS scores into a novel scoring system led to significant prostate cancer detection rates with tiered detection rate of 39%, 58%, 81% and 100% for Gleason grade group II, III, IV, and V, respectively. The area-under-the-curve for our novel sum score in receiver operating characteristic analysis was 0.84. The synergistic combination of two non-invasive tests into a sum score with increased sensitivity may help avoiding unnecessary biopsies for initial prostate cancer diagnosis. For confirmation, further prospective studies with larger sample sizes and univariate and multivariate regression analyses and decision curve analyses are required.
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These authors jointly supervised this work.
Competing Interests: The authors received no specific funding for this work. The authors thank the “Fritz und Gertrud Stegmeier Stiftung” for the general financial support. There are no patents, products in development or marketed products to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0271981