Observational StudyA Single-arm, Multicenter Prospective Study to Evaluate the Diagnostic Performance of PROSTest in Men With PSA ≥ 3ng/ml Using Biopsy as the Sole Ground Truth

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.