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.
elevated PSA and/or abnormal digital rectal examination
Previous Prostate cancer diagnosis
Men at risk for PCa based on age and or elevated PSA/abnormal DRE.
Cohort
Prospective
PROSTEST
Diagnostic testBLOOD SAMPLE FOR PROSTEST MEASUREMENT
Diagnostic accuracy of the PROSTest to detect prostate cancer at biopsy
Primary endpoint is diagnostic accuracy of PROSTest for PCa detection. Assay is scored 0-100 and has a cut-off of 50 for normal. A blood sample with a PROSTest score \> or equal than 50 are predicted to be a prostate cancer. The expectation is that \>85% of individuals who are biopsy positive are also PROSTest-positive. We anticipate \~400 individuals will be biopsy positive. Conversely, the expectation is that \>75% of individuals who are biopsy negative will also be PROSTest-negative. We anticipate \~600 individuals will be biopsy negative. This will allow us to derive diagnostic metrics for the assay using biopsy-status as the gold standard.
Diagnostics metrics for the PROSTest
Secondary endpoint includes investigating whether there is a correlation between the PROSTest score (scaled 0-100) and the Gleason grade group.
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