A 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
About this study
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.
- Condition
- Prostate Cancer, Urology, Prostate Cancer (Diagnosis)
- Tested
- PROSTEST
- Sponsor
- Wren Laboratories LLC
Who can join
- Age
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 5
- Minimum age: 45 years
- Maximum age: 80 years
- Eligible sex: Male
- Study condition: Prostate Cancer, Urology, Prostate Cancer (Diagnosis)
- elevated PSA and/or abnormal digital rectal examination
Exclusion 1
- Previous Prostate cancer diagnosis
Where
1 site, 1 recruiting
Wren Laboratories
Branford, Connecticut, United States
Contact
-
Mark Kidd, PhD
2038241128 mkidd@wrenlaboratories.com
-
Tracy Auster, BS
2032083464 tauster@wrenlaboratories.com
Potential match only. Final eligibility is determined by the study team.