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Clinical Utility of 4Kscore, ExosomeDx and Magnetic Resonance Imaging for the Early Detection of High-Grade Prostate Cancer - Beyond the Abstract

As treatment paradigms for prostate cancer have drastically changed over the past decade and most low-grade cancers are now safely monitored with active surveillance, the need for effective screening tools that adequately risk-stratify patients prior to considering prostate biopsy is more important than ever. Liquid biomarkers 4Kscore® and ExosomeDxTM were developed to identify patients at risk for high-grade prostate cancer (here defined as Gleason grade 2 or higher). Multiparametric magnetic resonance imaging (mpMRI) has also been proposed as an imaging-based screening tool prior to prostate biopsy, however, it is unclear when and how to combine mpMRI with liquid biomarkers.


In this study, using a retrospective cohort of our center’s experience, we identified 783 patients with either 4Kscore® or ExosomeDxTM testing, most of which had had a mpMRI done as well. In this cohort, the liquid biomarkers alone would have missed <5% of high-grade cancers and avoid around 30% of unnecessary biopsies. We defined several screening algorithms including upfront liquid biomarker testing followed by mpMRI, other with upfront mpMRI testing followed by liquid biomarker testing and we defined algorithms that use mpMRI only at certain liquid biomarker thresholds. The balance of missed high-grade cancers and avoided unnecessary biopsies were evaluated for each algorithm. We found that some of these algorithms would lead to avoiding up to around 45% of unnecessary biopsies while still missing <5% of high-grade cancers.

This study is limited by its retrospective nature and lack of head to head comparison of the liquid biomarkers or mpMRI, however, such biomarker-directed screening could be of value for both clinicians and patients to avoid unnecessary biopsies and reduce overdetection of low-grade cancers and should be validated in a larger prospective trial.

Written by: Claire de la Calle, MD, Urology Resident, University of California San Francisco

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