Non-invasive Urine Test for Molecular Classification of Clinical Significance in Newly Diagnosed Prostate Cancer Patients

Guo，Jinan1,2,3; Zhang，Xuhui4; Xia，Taolin5; Johnson，Heather6; Feng，Xiaoyan4; Simoulis，Athanasios7; Wu，Alan H.B.8; Li，Fei9; Tan，Wanlong9; Johnson，Allan10; Dizeyi，Nishtman11; Abrahamsson，Per Anders11; Kenner，Lukas12; Xiao，Kefeng1,2,3; Zhang，Heqiu4; Chen，Lingwu13; Zou，Chang1,2,3,14; Persson，Jenny L.15,16,17

2021-09-14

10.3389/fmed.2021.721554

Frontiers in Medicine   影响因子和分区

2296-858X

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.

active surveillance clinically significant prostate cancer gene panel liquid biopsy prostate cancer prostate cancer risk urine test

SCI

英语

第一 ; 通讯

WOS:000704526800001

2-s2.0-85116002027

Scopus

1.Shenzhen People's Hospital,The Second Clinical Medical College,Jinan University,The First Affiliated Hospital,Southern University of Science and Technology),Shenzhen,China
2.Shenzhen Urology Minimally Invasive Engineering Center,Shenzhen,China
3.Shenzhen Public Service Platform on Tumor Precision Medicine and Molecular Diagnosis,Clinical Medicine Research Centre,Shenzhen,China
4.Department of Bio-diagnosis,Institute of Basic Medical Sciences,Beijing,China
5.Department of Urology,Foshan First People's Hospital,Foshan,China
6.Olympia Diagnostics,Inc,Sunnyvale,United States
7.Department of Clinical Pathology and Cytology,Skåne University Hospital,Malmö,Sweden
8.Clinical Laboratories,San Francisco General Hospital,San Francisco,United States
9.Department of Urology,Nanfang Hospital,Southern Medical University,Guangzhou,China
10.Kinetic Reality,Santa Clara,United States
11.Department of Translational Medicine,Clinical Research Centre,Lund University,Malmö,Sweden
12.Department of Experimental Pathology,Medical University Vienna Unit of Laboratory Animal Pathology,University of Veterinary Medicine,Vienna,Austria
13.Department of Urology,The First Affiliated Hospital of Sun Yat-sen University,Guangzhou,China
14.Key Laboratory of Medical Electrophysiology of Education Ministry,School of Pharmacy,Southwest Medical University,Luzhou,China
15.Department of Molecular Biology,Umeå University,Umeå,Sweden
16.Department of Biomedical Sciences,Malmö University,Malmö,Sweden
17.Division of Experimental Cancer Research,Department of Translational Medicine,Lund University,Malmö,Sweden

Guo，Jinan,Zhang，Xuhui,Xia，Taolin,et al. Non-invasive Urine Test for Molecular Classification of Clinical Significance in Newly Diagnosed Prostate Cancer Patients[J]. Frontiers in Medicine,2021,8.

Guo，Jinan.,Zhang，Xuhui.,Xia，Taolin.,Johnson，Heather.,Feng，Xiaoyan.,...&Persson，Jenny L..(2021).Non-invasive Urine Test for Molecular Classification of Clinical Significance in Newly Diagnosed Prostate Cancer Patients.Frontiers in Medicine,8.

Guo，Jinan,et al."Non-invasive Urine Test for Molecular Classification of Clinical Significance in Newly Diagnosed Prostate Cancer Patients".Frontiers in Medicine 8(2021).