---
title: "Urine-based 19-biomarker CE-MS test prospectively predicts clinically significant prostate cancer"
id: "british-journal-of-cancer-0-prospective-validation-of-a-urine-based-proteomics-test-for-predicting"
canonical_url: "https://medichelpline.com/clinical-feed/british-journal-of-cancer-0-prospective-validation-of-a-urine-based-proteomics-test-for-predicting"
content_type: "clinical_feed_article"
specialty: "Oncology"
source_name: "British Journal of Cancer"
source_url: "https://www.nature.com/articles/s41416-026-03602-y"
published_at: "2026-08-29T12:00:00.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Urine-based 19-biomarker CE-MS test prospectively predicts clinically significant prostate cancer
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/british-journal-of-cancer-0-prospective-validation-of-a-urine-based-proteomics-test-for-predicting
- **Specialty:** [Oncology](https://medichelpline.com/clinical-feed/oncology.md)
- **Primary Source:** British Journal of Cancer
- **Source URL:** [Original Journal Publication](https://www.nature.com/articles/s41416-026-03602-y)
- **Published At:** 2026-08-29T12:00:00.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- This prospective clinical study validated a urine-based **19-biomarker model (19-BM)** measured by capillary electrophoresis–mass spectrometry (CE-MS) to predict **clinically significant prostate cancer (csPCa)** in biopsy‑naïve patients at risk. - A total of 161 biopsy‑naïve patients underwent pre-biopsy urine CE‑MS, multiparametric MRI (**mpMRI**), and prostate biopsy at two hospitals; 100 patients who received radical prostatectomy were assessed for correlation between 19-BM scores and prostatectomy pathology. - The 19-BM achieved an Area Under the ROC Curve (**AUC**) of 0.79, outperforming **PSA** (AUC 0.54), ERSPC risk calculator (AUC 0.63), PSA density (PSAD, AUC 0.61), and **mpMRI** (AUC 0.65); reported p values show statistical significance versus each comparator as reported in the source. - In patients with low Prostate Imaging Reporting and Data System (**PI-RADS**) scores, the 19-BM showed sensitivity of 75% and specificity of 90%, indicating potential utility where mpMRI is less informative. - A previously published nomogram combining 19-BM and mpMRI was prospectively validated in this cohort and yielded an AUC of 0.82 with specificity 90% and sensitivity 64% in this study. - Authors conclude that the urine-based 19-BM demonstrates robust prospective performance for predicting csPCa and could complement current diagnostic pathways to reduce unnecessary biopsies; combining 19-BM with mpMRI may further enhance discrimination. - Study limitations and detailed methodology were reported in the source article; full-text access may be required for additional procedural, demographic, and statistical details not included in the preview. - The study datasets are publicly available in the Zenodo repository at the reported DOI.
## Clinical Analysis & Structured Key Points
[Skip to main content](https://www.nature.com/articles/s41416-026-03602-y#content) Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript. Advertisement [ ![British Journal of Cancer](https://media.springernature.com/full/nature-cms/uploads/product/bjc/header-76ac17391903a21e28f15ff5df31f5fa.svg) ](https://www.nature.com/bjc) * [ View all journals ](https://www.nature.com/siteindex) * [ Saved research ](https://www.nature.com/saved-research) * [ Search ](javascript:;) ## Search Search articles by subject, keyword or author Show results from All journals This journal Search [ Advanced search ](https://www.nature.com/search/advanced) ### Quick links * [Explore articles by subject](https://www.nature.com/subjects) * [Find a job](https://www.nature.com/naturecareers) * [Guide to authors](https://www.nature.com/authors/index.html) * [Editorial policies](https://www.nature.com/authors/editorial_policies/) * [Log in](https://idp.nature.com/auth/personal/springernature?redirect_uri=https://www.nature.com/articles/s41416-026-03602-y) * [ Content Explore content ](javascript:;) ## Explore content * [ Research articles ](https://www.nature.com/bjc/research-articles) * [ Reviews & Analysis ](https://www.nature.com/bjc/reviews-and-analysis) * [ News & Comment ](https://www.nature.com/bjc/news-and-comment) * [ Current issue ](https://www.nature.com/bjc/current-issue) * [ Collections ](https://www.nature.com/bjc/collections) * [Follow us on X ](https://twitter.com/BrJCancer) * [ Subscribe ](https://www.nature.com/bjc/subscribe) * [Sign up for alerts ](https://journal-alerts.springernature.com/subscribe?journal_id=41416) * [ RSS feed ](https://www.nature.com/bjc.rss) * [ About the journal ](javascript:;) ## About the journal * [ Journal Information ](https://www.nature.com/bjc/journal-information) * [ Open access publishing ](https://www.nature.com/bjc/open-access) * [ About the Editors ](https://www.nature.com/bjc/editors) * [ Contact ](https://www.nature.com/bjc/contact) * [ Special Issues ](https://www.nature.com/bjc/special-issues) * [ For Advertisers ](https://www.nature.com/bjc/advertising) * [ Subscribe ](https://www.nature.com/bjc/subscribe) * [ Publish with us ](javascript:;) ## Publish with us * [ For Authors & Referees ](https://www.nature.com/bjc/authors-and-referees) * [ Language editing services ](https://authorservices.springernature.com/go/sn/?utm_source=For+Authors&utm_medium=Website_Nature&utm_campaign=Platform+Experimentation+2022&utm_id=PE2022) * [Open access funding](https://www.nature.com/bjc/open-access-funding) * [Submit manuscript ](https://mts-bjcancer.nature.com/) * [ Subscribe ](https://www.nature.com/bjc/subscribe) * [ Sign up for alerts ](https://journal-alerts.springernature.com/subscribe?journal_id=41416) * [ RSS feed ](https://www.nature.com/bjc.rss) 1. [nature](https://www.nature.com/) 2. [british journal of cancer](https://www.nature.com/bjc) 3. [articles](https://www.nature.com/bjc/articles?type=article) 4. article * Article * Published: 29 August 2026 Clinical Study # Prospective validation of a urine-based proteomics test for predicting clinically significant prostate cancer in biopsy-naïve patients * [Ana C. Morillo](https://www.nature.com/articles/s41416-026-03602-y#auth-Ana_C_-Morillo-Aff1)[1](https://www.nature.com/articles/s41416-026-03602-y#Aff1) [na1](https://www.nature.com/articles/s41416-026-03602-y#na1), * [Kirubel Nigusu Jobre](https://www.nature.com/articles/s41416-026-03602-y#auth-Kirubel_Nigusu-Jobre-Aff2)[2](https://www.nature.com/articles/s41416-026-03602-y#Aff2) [na1](https://www.nature.com/articles/s41416-026-03602-y#na1), * [Guillermo Lendinez Cano](https://www.nature.com/articles/s41416-026-03602-y#auth-Guillermo-Lendinez_Cano-Aff3)[3](https://www.nature.com/articles/s41416-026-03602-y#Aff3), * [Ana Blanca-Pedregosa](https://www.nature.com/articles/s41416-026-03602-y#auth-Ana-Blanca_Pedregosa-Aff1)[1](https://www.nature.com/articles/s41416-026-03602-y#Aff1), * [Daniel Lopez Ruiz](https://www.nature.com/articles/s41416-026-03602-y#auth-Daniel-Lopez_Ruiz-Aff4)[4](https://www.nature.com/articles/s41416-026-03602-y#Aff4), * [Jose Parada](https://www.nature.com/articles/s41416-026-03602-y#auth-Jose-Parada-Aff5)[5](https://www.nature.com/articles/s41416-026-03602-y#Aff5), * [Isabel Heidegger](https://www.nature.com/articles/s41416-026-03602-y#auth-Isabel-Heidegger-Aff6)[6](https://www.nature.com/articles/s41416-026-03602-y#Aff6), * [Zoran Culig](https://www.nature.com/articles/s41416-026-03602-y#auth-Zoran-Culig-Aff6)[6](https://www.nature.com/articles/s41416-026-03602-y#Aff6), * [Antonio Lopez-Beltran](https://www.nature.com/articles/s41416-026-03602-y#auth-Antonio-Lopez_Beltran-Aff7)[7](https://www.nature.com/articles/s41416-026-03602-y#Aff7), * [Julia Carrasco-Valiente](https://www.nature.com/articles/s41416-026-03602-y#auth-Julia-Carrasco_Valiente-Aff1)[1](https://www.nature.com/articles/s41416-026-03602-y#Aff1), * [Harald Mischak](https://www.nature.com/articles/s41416-026-03602-y#auth-Harald-Mischak-Aff2-Aff8)[2](https://www.nature.com/articles/s41416-026-03602-y#Aff2),[8](https://www.nature.com/articles/s41416-026-03602-y#Aff8), * [Rafael A. Medina](https://www.nature.com/articles/s41416-026-03602-y#auth-Rafael_A_-Medina-Aff3)[3](https://www.nature.com/articles/s41416-026-03602-y#Aff3), * [Juan P. Campos Hernandez](https://www.nature.com/articles/s41416-026-03602-y#auth-Juan_P_-Campos_Hernandez-Aff1)[1](https://www.nature.com/articles/s41416-026-03602-y#Aff1), * [Maria Frantzi](https://www.nature.com/articles/s41416-026-03602-y#auth-Maria-Frantzi-Aff2)[2](https://www.nature.com/articles/s41416-026-03602-y#Aff2) & * … * [Enrique Gómez Gómez](https://www.nature.com/articles/s41416-026-03602-y#auth-Enrique-G_mez_G_mez-Aff1) [ORCID: orcid.org/0000-0002-8753-3306](https://orcid.org/0000-0002-8753-3306)[1](https://www.nature.com/articles/s41416-026-03602-y#Aff1) Show authors [_British Journal of Cancer_](https://www.nature.com/bjc) (2026) [Cite this article](https://www.nature.com/articles/s41416-026-03602-y#citeas) [ Save article ](https://www.nature.com/articles/s41416-026-03602-y/save-research?_csrf=Jc5Qt-sORWo9u1fUFZUWejHyGO3b36kL) [ View saved research ](https://www.nature.com/saved-research) ## Abstract ### Background and objective Prostate cancer (PCa) remains a major health burden, while existing diagnostic approaches are limited by overdiagnosis that leads to unnecessary biopsies, and by underdetection of clinically significant disease (csPCa). This study aims to prospectively validate a urine-based 19-biomarker model (19-BM) using capillary electrophoresis–mass spectrometry (CE-MS) for predicting csPCa in patients at risk. ### Methods One hundred sixty-one biopsy-naïve patients at risk for csPCa underwent pre-biopsy CE-MS analysis in urine, multiparametric magnetic resonance imaging (mpMRI), and biopsy at two major hospitals. The 19-BM performance was assessed in comparison with Prostate-Specific Antigen (PSA), the European Randomised Study of Screening for Prostate Cancer (ERSPC), and mpMRI. Performance metrics included Area Under the ROC Curve (AUC), sensitivity, specificity, negative, and positive predictive values. One hundred patients receiving radical prostatectomy were evaluated to investigate the correlation of the 19-BM scores with the prostatectomy pathology. ### Key findings and limitations The 19-BM scores achieved an AUC of 0.79, outperforming PSA (AUC 0.54, _p_ . ## References 1. Cornford P, Van Den Bergh RCN, Briers E, Van Den Broeck T, Brunckhorst O, Darraugh J, et al. EAU-EANM-ESTRO-ESUR-ISUP-SIOG Guidelines on Prostate Cancer—2024 Update. Part I: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2024;86:148–63. . [Article](https://doi.org/10.1016%2Fj.eururo.2024.03.027) [PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=38614820) [ Google Scholar](http://scholar.google.com/scholar_lookup?&title=EAU-EANM-ESTRO-ESUR-ISUP-SIOG%20Guidelines%20on%20Prostate%20Cancer%E2%80%942024%20Update.%20Part%20I%3A%20Screening%2C%20Diagnosis%2C%20and%20Local%20Treatment%20with%20Curative%20Intent&journal=Eur%20Urol&doi=10.1016%2Fj.eururo.2024.03.027&volume=86&pages=148-63&publication_year=2024&author=Cornford%2CP&author=Bergh%2CRCN&author=Briers%2CE&author=Broeck%2CT&author=Brunckhorst%2CO&author=Darraugh%2CJ) 2. Culp MB, Soerjomataram I, Efstathiou JA, Bray F, Jemal A. Recent Global Patterns in Prostate Cancer Incidence and Mortality Rates. Eur Urol. 2020;77:38–52. . [Article](https://doi.org/10.1016%2Fj.eururo.2019.08.005) [PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=31493960) [ Google Scholar](http://scholar.google.com/scholar_lookup?&title=Recent%20Global%20Patterns%20in%20Prostate%20Cancer%20Incidence%20and%20Mortality%20Rates&journal=Eur%20Urol&doi=10.1016%2Fj.eururo.2019.08.005&volume=77&pages=38-52&publication_year=2020&author=Culp%2CMB&author=Soerjomataram%2CI&author=Efstathiou%2CJA&author=Bray%2CF&author=Jemal%2CA) 3. Frantzi M, Heidegger I, Roesch MC, Gomez-Gomez E, Steiner E, Vlahou A, et al. Validation of diagnostic nomograms based on CE-MS urinary biomarkers to detect clinically significant prostate cancer. World J Urol. 2022;40:2195–203. . [Article](https://link.springer.com/doi/10.1007/s00345-022-04077-1) [CAS](https://www.nature.com/articles/cas-redirect/1:CAS:528:DC%2BB38Xit1SlsLrJ) [PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=35841414) [PubMed Central](http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9427869) [ Google Scholar](http://scholar.google.com/scholar_lookup?&title=Validation%20of%20diagnostic%20nomograms%20based%20on%20CE-MS%20urinary%20biomarkers%20to%20detect%20clinically%20significant%20prostate%20cancer&journal=World%20J%20Urol&doi=10.1007%2Fs00345-022-04077-1&volume=40&pages=2195-203&publication_year=2022&author=Frantzi%2CM&author=Heidegger%2CI&author=Roesch%2CMC&author=Gomez-Gomez%2CE&author=Steiner%2CE&author=Vlahou%2CA) 4. Israël B, Hannink G, Barentsz JO, Van Der Leest MMG. Implications of the European Association of Urology Recommended Risk Assessment Algorithm for Early Prostate Cancer Detection. Eur Urol Open Sci. 2022;43:1–4. . [Article](https://doi.org/10.1016%2Fj.euros.2022.06.006) [PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=35845549) [PubMed Central](http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9278493) [ Google Scholar](http://scholar.google.com/scholar_lookup?&title=Implications%20of%20the%20European%20Association%20of%20Urology%20Recommended%20Risk%20Assessment%20Algorithm%20for%20Early%20Prostate%20Cancer%20Detection&journal=Eur%20Urol%20Open%20Sci&doi=10.1016%2Fj.euros.2022.06.006&volume=43&pages=1-4&publication_year=2022&author=Isra%C3%ABl%2CB&author=Hannink%2CG&author=Barentsz%2CJO&author=Leest%2CMMG) 5. Fenton JJ, Weyrich MS, Durbin S, Liu Y, Bang H, Melnikow J. Prostate-specific antigen-based screening for prostate cancer: evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2018;319:1914–31. . [Article](https://doi.org/10.1001%2Fjama.2018.3712) [PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=29801018) [ Google Scholar](http://scholar.google.com/scholar_lookup?&title=Prostate-specific%20antigen-based%20screening%20for%20prostate%20cancer%3A%20evidence%20report%20and%20systematic%20review%20for%20the%20US%20Preventive%20Services%20Task%20Force&journal=JAMA&doi=10.1001%2Fjama.2018.3712&volume=319&pages=1914-31&publication_year=2018&author=Fenton%2CJJ&author=Weyrich%2CMS&author=Durbin%2CS&author=Liu%2CY&author=Bang%2CH&author=Melnikow%2CJ) 6. Naji L, Randhawa H, Sohani Z, Dennis B, Lautenbach D, Kavanagh O, et al. Digital rectal examination for prostate cancer screening in primary care: a systematic review and meta-analysis. Ann Fam Med. 2018;16:149–54. . [Article](https://doi.org/10.1370%2Fafm.2205) [PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=29531107) [PubMed Central](http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5847354) [ Google Scholar](http://scholar.google.com/scholar_lookup?&title=Digital%20rectal%20examination%20for%20prostate%20cancer%20screening%20in%20primary%20care%3A%20a%20systematic%20review%20and%20meta-analysis&journal=Ann%20Fam%20Med&doi=10.1370%2Fafm.2205&volume=16&pages=149-54&publication_year=2018&author=Naji%2CL&author=Randhawa%2CH&author=Sohani%2CZ&author=Dennis%2CB&author=Lautenbach%2CD&author=Kavanagh%2CO) 7. Turkbey B, Rosenkrantz AB, Haider MA, Padhani AR, Villeirs G, Macura KJ, et al. Prostate Imaging Reporting and Data System Version 2.1: 2019 Update of Prostate Imaging Reporting and Data System Version 2. Eur Urol. 2019;76:340–51. . [Article](https://doi.org/10.1016%2Fj.eururo.2019.02.033) [PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=30898406) [ Google Scholar](http://scholar.google.com/scholar_lookup?&title=Prostate%20Imaging%20Reporting%20and%20Data%20System%20Version%202.1%3A%202019%20Update%20of%20Prostate%20Imaging%20Reporting%20and%20Data%20System%20Version%202&journal=Eur%20Urol&doi=10.1016%2Fj.eururo.2019.02.033&volume=76&pages=340-51&publication_year=2019&author=Turkbey%2CB&author=Rosenkrantz%2CAB&author=Haider%2CMA&author=Padhani%2CAR&author=Villeirs%2CG&author=Macura%2CKJ) 8. Drost FJH, Osses DF, Nieboer D, Steyerberg EW, Bangma CH, Roobol MJ, et al. Prostate MRI, with or without MRI-targeted biopsy, and systematic biopsy for detecting prostate cancer. Cochrane Urology Group, ed. Cochrane Database Syst Rev. 2019;2019. 9. Giganti F, Ng A, Asif A, Chan VWS, Rossiter M, Nathan A, et al. Global variation in magnetic resonance imaging quality of the prostate. Radiology. 2023;309:e231130. . [Article](https://doi.org/10.1148%2Fradiol.231130) [PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=37815448) [ Google Scholar](http://scholar.google.com/scholar_lookup?&title=Global%20variation%20in%20magnetic%20resonance%20imaging%20quality%20of%20the%20prostate&journal=Radiology&doi=10.1148%2Fradiol.231130&volume=309&publication_year=2023&author=Giganti%2CF&author=Ng%2CA&author=Asif%2CA&author=Chan%2CVWS&author=Rossiter%2CM&author=Nathan%2CA) 10. Sonn GA, Fan RE, Ghanouni P, Wang NN, Brooks JD, Loening AM, et al. Prostate magnetic resonance imaging interpretation varies substantially across radiologists. Eur Urol Focus. 2019;5:592–9. . [Article](https://doi.org/10.1016%2Fj.euf.2017.11.010) [PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=29226826) [ Google Scholar](http://scholar.google.com/scholar_lookup?&title=Prostate%20magnetic%20resonance%20imaging%20interpretation%20varies%20substantially%20across%20radiologists&journal=Eur%20Urol%20Focus&doi=10.1016%2Fj.euf.2017.11.010&volume=5&pages=592-9&publication_year=2019&author=Sonn%2CGA&author=Fan%2CRE&author=Ghanouni%2CP&author=Wang%2CNN&author=Brooks%2CJD&author=Loening%2CAM) 11. Westphalen AC, McCulloch CE, Anaokar JM, Arora S, Barashi NS, Barentsz JO, et al. Variability of the positive predictive value of PI-RADS for prostate MRI across 26 centers: experience of the Society of Abdominal Radiology Prostate Cancer Disease-focused Panel. Radiology. 2020;296:76–84. . [Article](https://doi.org/10.1148%2Fradiol.2020190646) [PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=32315265) [PubMed Central](http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7373346) [ Google Scholar](http://scholar.google.com/scholar_lookup?&title=Variability%20of%20the%20positive%20predictive%20value%20of%20PI-RADS%20for%20prostate%20MRI%20across%2026%20centers%3A%
## Related Clinical Research

- [[177Lu]Lu-PSMA-617 for PSMA-positive metastatic androgen-pathway–sensitive prostate cancer (PSMAdd](https://medichelpline.com/clinical-feed/pubmed-42561994.md) (DOI: 10.1016/S0140-6736(26)01092-5)
- [ARMS DNAseq: scalable spatial DNA sequencing for mapping copy-number subclones in archival tissue](https://medichelpline.com/clinical-feed/biorxiv-17-scalable-spatial-dna-sequencing-from-archival-tissue-maps-copy-number-subclones.md)
- [Cold atmospheric plasma causes selective oxidative toxicity in prostate cancer cells](https://medichelpline.com/clinical-feed/pubmed-42259195.md) (DOI: 10.1016/j.bbrc.2026.154110)
- [Transcriptomic bottlenecks shaping response to peptide cancer vaccines](https://medichelpline.com/clinical-feed/biorxiv-6-phase-resolved-transcriptomic-bottlenecks-in-peptide-cancer-vaccine-response.md)
- [Moderna and Merck's mRNA Cancer Vaccine: Inside the Melanoma Trial Breakthrough](https://medichelpline.com/clinical-feed/stat-news-0-stat-inside-moderna-and-merck-s-cancer-vaccine-triumph.md)

## Navigation
- [← Back to Oncology Feed](https://medichelpline.com/clinical-feed/oncology.md)
- [← All Clinical Specialties](https://medichelpline.com/clinical-feed.md)
## Medical & Regulatory Disclaimer

> [!CAUTION]
> MedicHelpline content is structured for research, educational, and professional discovery purposes. It does not constitute individual medical advice, clinical diagnosis, or treatment recommendations.
> Always verify dosing, contraindications, and regulatory alerts against official product labeling and primary regulatory sources before clinical decision-making.