A Prospective Clinical Trial Evaluating PROSTest, a Blood-Based Molecular Assay, for Risk Stratification and Biopsy Decision Support in Men With Suspected Prostate Cancer
Wren Laboratories LLC
Summary
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.
Description
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. Diagnostic performance metrics including sensitivity, specificity, negative predictive value, and area under the receiver operating characteristic curve will be calculated. Decision-curve analyses will assess potential reductions in…
Eligibility
- Age range
- 45–80 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * elevated PSA and/or abnormal digital rectal examination Exclusion Criteria: * Previous Prostate cancer diagnosis
Interventions
- Diagnostic TestPROSTEST
BLOOD SAMPLE FOR PROSTEST MEASUREMENT
Location
- Wren LaboratoriesBranford, Connecticut