# A Novel Urine Exosome Gene Expression Assay to Predict High-grade Prostate Cancer at Initial Biopsy

Source: https://onco.cc/key-papers/paper-mckiernan-urine-exosome-prostate-jama-oncol-2016/  
OnCo record `paper-mckiernan-urine-exosome-prostate-jama-oncol-2016` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The validation of a three-gene urine vesicle test that predicted high-grade prostate cancer at first biopsy better than standard clinical factors alone.

## Summary

In independent validation in 519 patients, the urine exosome assay plus standard of care had an area under the curve of 0.73 (95% CI 0.68 to 0.77) against 0.63 for standard of care alone; 138 of 519 biopsies (27 per cent) would have been avoided, missing 5 per cent of patients with dominant pattern 4 high-risk Gleason 7 disease.

## Fields

- Kind: Key paper
- Last checked: 2026-11-04
- Journal: JAMA Oncology
- Year: 2016
- DOI: 10.1001/jamaoncol.2016.0097
- Authors: McKiernan J, Donovan MJ, O'Neill V, et al.
- Findings: Area under the curve 0.73 against 0.63.; 27% of biopsies avoidable.
- What it means: A urine RNA test can help some men skip a first prostate biopsy.
- Caveats: Industry-sponsored; before MRI-first pathways were routine.

## Sources

- McKiernan et al., JAMA Oncol 2016: https://doi.org/10.1001/jamaoncol.2016.0097
- PubMed: https://pubmed.ncbi.nlm.nih.gov/27032035/

## Connected records

- cancers: [Prostate cancer](https://onco.cc/cancers/prostate/)
- fronts: [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/)
- technologies: [Liquid RNA biopsy (cell-free, vesicle and platelet RNA)](https://onco.cc/technologies/liquid-rna-biopsy/), [PSA and MRI-first prostate cancer screening](https://onco.cc/technologies/prostate-screening-psa-mri/)
- drugs: [ExoDx Prostate (IntelliScore)](https://onco.cc/drugs/exodx-prostate/)
- terms: [Biomarker](https://onco.cc/terms/biomarker/)

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