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
Recruiting · NCT07454603 · Observational (researchers observe without assigning treatment) · Lead sponsor: Wren Laboratories LLC
View the official record on ClinicalTrials.gov →Interventions studied
PROSTEST
What this trial is about
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.
Who can take part
Age range
45 Years to 80 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- elevated PSA and/or abnormal digital rectal examination
Exclusion criteria
- Previous Prostate cancer diagnosis
Where it is running
1 location listed across 1 US state.
- Wren Laboratories - Branford, Connecticut, United States