The impact of urine biomarkers for prostate cancer detection–A systematic state of the art review

Background

Prostate cancer (PCa) screening primarily relies on Prostate-Specific Antigen (PSA), which has low specificity and therefore leads to unnecessary biopsies. Consequently, there is a growing need for, ideally, non-invasive biomarkers. Liquid biopsy, a diagnostic approach analyzing circulating tumor components in body fluids, has emerged as a promising diagnostic tool for various cancers, including PCa.

Methods

To evaluate recent evidence on urine-based biomarkers for the detection of PCa, we conducted a systematic review in accordance with the PRISMA guidelines. Our literature search identified a total of 286 studies, of which 66 met our inclusion criteria (men suspected of PCa with no prior history of PCa). After assessing the risk of bias using the QUADAS-2 tool, studies on five distinct urinary biomarker tests were included for further analysis.

Results

Tests that do not rely on digital rectal examination (non-DRE), such as Exosome Dx Prostate IntelliScore (EPI) and Protexam Prostate Status Management (PSM)/Prostate Check-Up (PSU), demonstrated strong performance in detecting PCa, particularly clinically significant PCa. Meanwhile, the MyProstateScore test (MPS) showed the highest efficacy among tests utilizing urine samples collected post-DRE. Unfortunately, the performance of the biomarker test with the most available studies, PCA3 ProGensa® Score, was underwhelming with only moderate sensitivity and specificity.

Conclusions

Despite promising results from various urine-based biomarker tests, we are currently unable to recommend one specific test for implementation into clinical practice. The broad heterogeneity of the studies conducted hindered the ability to perform a meta-analysis, and prospective randomized trials providing clinical evidence are still lacking.