Development and validation of the utLIFE-PC algorithm for noninvasive detection of prostate cancer in urine: A prospective, observational study
Overbiopsy is a serious health issue in prostate cancer (PCa) diagnostics. We have developed a urine tumor DNA multidimensional bioinformatic algorithm, utLIFE, to avoid unnecessary biopsy. The objective is to recognize all or clinically significant PCa. Of the 801 participants recruited in our study, 630 are selected for subsequent analysis. In the training cohort (n = 237), utLIFE-PC gets an area under the receiver operating characteristic curve (AUC) of 0.967 and a sensitivity of 85.57% at 95% specificity. In the independent prospective validation cohort (n = 343), utLIFE-PC has an AUC of 0.929, sensitivity of 84.24%, and specificity of 93.26%. Notably, in patients with ≥grade group (GG)2 and ≥GG3, the assay's sensitivity is still excellent (85.33% and 87.10%, respectively). The model shows better performance than prostate-specific antigen (PSA) (p < 0.001) or the single-dimensional biomarkers (methylation, p < 0.001; copy-number variations [CNVs], p < 0.001; mutation, p < 0.001). The utLIFE-PC model can potentially optimize the PCa diagnostic process and avoid unnecessary biopsies. This study was registered at Chinese Clinical Trial Registry: ChiCTR2300071837.
Authors
- Yanrui Zhang
- Huanqing Cheng (ORCID: https://orcid.org/0000-0002-5900-7050)
- Nianzeng Xing (ORCID: https://orcid.org/0000-0002-2696-5279)
- Mingshuai Wang (ORCID: https://orcid.org/0000-0002-9919-4348)
- Shuaipeng Zhu
- Yi Zhi (ORCID: https://orcid.org/0000-0002-9114-2543)
- Gejun Zhang (ORCID: https://orcid.org/0000-0003-3482-5468)
- Junlong Wu (ORCID: https://orcid.org/0000-0002-4125-7975)
- Yuanjie Niu
- Weigang Yan (ORCID: https://orcid.org/0000-0002-8995-1456)
- Hengqing An (ORCID: https://orcid.org/0009-0003-7738-8824)
- Lei Liu (ORCID: https://orcid.org/0000-0002-3630-3674)
- Zhiyuan Chen (ORCID: https://orcid.org/0000-0003-1405-642X)
- Feng Lou
- Jianbin Bi (ORCID: https://orcid.org/0000-0002-1626-2609)
- Dingwei Ye (ORCID: https://orcid.org/0000-0003-4974-3780)
- Zhaoxia Guo (ORCID: https://orcid.org/0009-0001-6327-8136)
- Xiao Liu (ORCID: https://orcid.org/0000-0003-1165-8775)
- Sujun Han
- Huina Wang (ORCID: https://orcid.org/0000-0003-2895-1361)
- Linjun Hu
- Shanbo Cao
- Xiaofu Qiu
- Meng Wang (ORCID: https://orcid.org/0000-0002-7417-9192)
- Yong Wang (ORCID: https://orcid.org/0000-0003-0695-5273)
- Ranlu Liu (ORCID: https://orcid.org/0000-0003-0425-4430)
- Libin Chen (ORCID: https://orcid.org/0009-0007-1254-1487)
Institutions
- Xinjiang Medical University (CN)
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- Peking Union Medical College Hospital (CN)
- First Affiliated Hospital of Xinjiang Medical University (CN)
- Wuhan University (CN)
- Fudan University Shanghai Cancer Center (CN)
- Second Hospital of Tianjin Medical University (CN)
- Renmin Hospital of Wuhan University (CN)
- First Hospital of China Medical University (CN)
- Guangdong Provincial People's Hospital (CN)
- Tianjin Medical University (CN)
- Chongqing Medical University (CN)
- China Medical University (CN)
Publication Details
- Journal
- Cell Reports Medicine
- Published
- 2024-12-01
- DOI
- https://doi.org/10.1016/j.xcrm.2024.101870
- Citations
- 3
- Primary Topic
- Prostate Cancer Diagnosis and Treatment
- Type
- article
- Field-Weighted Citation Impact
- 1.26
Funders
- National Key Research and Development Program of China