A Prospective Clinical Trial Evaluating PROSTest, a Blood-Based Molecular Assay, for Risk Stratification and Biopsy Decision Support in Men With Suspected Prostate Cancer

This prospective observational study will enroll men referred for prostate biopsy due to elevated PSA and/or abnormal digital rectal examination, with or without pre-biopsy MRI. Peripheral blood will be collected prior to biopsy for PROSTest analysis. Biopsy histopathology will serve as the reference standard. PROSTest results will be analyzed blinded to pathology.