Prognostic Evaluation of a Urine-Based Methylation Biomarker in Cell-Free DNA for Early Detection of Prostate Cancer - Abstract
Prostate Cancer (PCa) remains one of the most diagnosed malignancies among men, with current diagnostic methods presenting significant limitations. The
Prostate-Specific Antigen (PSA) test, while widely used, lacks specificity and can yield elevated results due to benign factors; some of these factors include
physical activity, sexual activity, or medication use which can often lead to unnecessary and invasive biopsies. The Digital Rectal Exam (DRE), another diagnostic
tool, is underutilized due to patient discomfort and stigma, particularly among African American (AA) men. This hesitancy contributes to a disproportionate
burden of advanced-stage PCa diagnoses and poorer outcomes in the AA community, who are typically diagnosed 3 to 5 years earlier and with more
aggressive disease compared to Non-Hispanic White (NHW) men.
To address these disparities and improve diagnostic accuracy, this study explores the potential of urinary biomarkers, specifically utilizing cell-free DNA
(cfDNA), as a non-invasive screening tool. Cell-free DNA, released by prostate cancer cells into prostatic fluid and subsequently into urine, has shown promise in
correlating with disease stage and clinical progression. The development of a urine-based cfDNA screening assay, coupled with Next Generation Sequencing
(NGS) to identify gene signatures, offers a novel approach to stratify patients by risk and guide treatment decisions. This method is particularly advantageous
for populations reluctant to undergo traditional screening and is well-suited for deployment in community health settings. The findings support the advancement
of cfDNA as a reliable, accessible, and equitable alternative to current PCa screening modalities.