PROSTest, a Novel Liquid Biopsy Molecular Assay, Accurately Guides Prostate Cancer Biopsy Decision-Making in Men with Elevated PSA Irrespective of DRE Findings.

ABSTRACT: Background/Objectives: Elevated PSAs combined with an abnormal digital rectal examination (DRE) are strong indicators of the possibility of a prostate cancer (PCa) and are used to guide biopsy decisions. We evaluated whether PROSTest, a novel, clinically validated, blood-based multigene mRNA test could aid in biopsy decision-making irrespective of DRE results in subjects ≥45 years with PSA ≥ 3 ng/mL. Methods: A retrospective cohort analysis was performed with a prespecified statistical analysis plan to test the null hypothesis that an abnormal DRE does not materially affect the sensitivity, specificity, or overall stratification performance of PROSTest. The pool included 327 subjects aged ≥45 years with abnormal PSA (≥3 ng/mL) who had undergone DRE and prostate biopsy. Diagno

SUBMITTER: Rogers CG 

PROVIDER: S-EPMC12730410 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature