AUTHOR=Guo Jinan , Zhang Xuhui , Xia Taolin , Johnson Heather , Feng Xiaoyan , Simoulis Athanasios , Wu Alan H. B. , Li Fei , Tan Wanlong , Johnson Allan , Dizeyi Nishtman , Abrahamsson Per-Anders , Kenner Lukas , Xiao Kefeng , Zhang Heqiu , Chen Lingwu , Zou Chang , Persson Jenny L.
TITLE=Non-invasive Urine Test for Molecular Classification of Clinical Significance in Newly Diagnosed Prostate Cancer Patients
JOURNAL=Frontiers in Medicine
VOLUME=8
YEAR=2021
URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2021.721554
DOI=10.3389/fmed.2021.721554
ISSN=2296-858X
ABSTRACT=Objective: To avoid over-treatment of low-risk prostate cancer patients, it is important to identify clinically significant and insignificant cancer for treatment decision-making. However, no accurate test is currently available.
Methods: To address this unmet medical need, we developed a novel gene classifier to distinguish clinically significant and insignificant cancer, which were classified based on the National Comprehensive Cancer Network risk stratification guidelines. A non-invasive urine test was developed using quantitative mRNA expression data of 24 genes in the classifier with an algorithm to stratify the clinical significance of the cancer. Two independent, multicenter, retrospective and prospective studies were conducted to assess the diagnostic performance of the 24-Gene Classifier and the current clinicopathological measures by univariate and multivariate logistic regression and discriminant analysis. In addition, assessments were performed in various Gleason grades/ISUP Grade Groups.
Results: The results showed high diagnostic accuracy of the 24-Gene Classifier with an AUC of 0.917 (95% CI 0.892–0.942) in the retrospective cohort (n = 520), AUC of 0.959 (95% CI 0.935–0.983) in the prospective cohort (n = 207), and AUC of 0.930 (95% 0.912-CI 0.947) in the combination cohort (n = 727). Univariate and multivariate analysis showed that the 24-Gene Classifier was more accurate than cancer stage, Gleason score, and PSA, especially in the low/intermediate-grade/ISUP Grade Group 1–3 cancer subgroups.
Conclusions: The 24-Gene Classifier urine test is an accurate and non-invasive liquid biopsy method for identifying clinically significant prostate cancer in newly diagnosed cancer patients. It has the potential to improve prostate cancer treatment decisions and active surveillance.