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

Guo, Jinan ; Zhang, Xuhui ; Xia, Taolin ; Johnson, Heather ; Feng, Xiaoyan ; Simoulis, Athanasios LU orcid ; Wu, Alan H.B. ; Li, Fei ; Tan, Wanlong and Johnson, Allan , et al. (2021) In Frontiers in Medicine 8.
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... (More)

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.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
active surveillance, clinically significant prostate cancer, gene panel, liquid biopsy, prostate cancer, prostate cancer risk, urine test
in
Frontiers in Medicine
volume
8
article number
721554
publisher
Frontiers Media S. A.
external identifiers
  • pmid:34595190
  • scopus:85116002027
ISSN
2296-858X
DOI
10.3389/fmed.2021.721554
language
English
LU publication?
yes
additional info
Publisher Copyright: © Copyright © 2021 Guo, Zhang, Xia, Johnson, Feng, Simoulis, Wu, Li, Tan, Johnson, Dizeyi, Abrahamsson, Kenner, Xiao, Zhang, Chen, Zou and Persson.
id
606c52dd-b9f2-4bd4-9fd5-85548067b5c3
date added to LUP
2021-10-21 11:39:34
date last changed
2024-03-23 11:59:20
@article{606c52dd-b9f2-4bd4-9fd5-85548067b5c3,
  abstract     = {{<p>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.</p>}},
  author       = {{Guo, Jinan and Zhang, Xuhui and Xia, Taolin and Johnson, Heather and Feng, Xiaoyan and Simoulis, Athanasios and Wu, Alan H.B. and Li, Fei and Tan, Wanlong and Johnson, Allan and Dizeyi, Nishtman and Abrahamsson, Per Anders and Kenner, Lukas and Xiao, Kefeng and Zhang, Heqiu and Chen, Lingwu and Zou, Chang and Persson, Jenny L.}},
  issn         = {{2296-858X}},
  keywords     = {{active surveillance; clinically significant prostate cancer; gene panel; liquid biopsy; prostate cancer; prostate cancer risk; urine test}},
  language     = {{eng}},
  publisher    = {{Frontiers Media S. A.}},
  series       = {{Frontiers in Medicine}},
  title        = {{Non-invasive Urine Test for Molecular Classification of Clinical Significance in Newly Diagnosed Prostate Cancer Patients}},
  url          = {{http://dx.doi.org/10.3389/fmed.2021.721554}},
  doi          = {{10.3389/fmed.2021.721554}},
  volume       = {{8}},
  year         = {{2021}},
}