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NOT YET RECRUITING
NCT07454603
A Prospective Clinical Trial Evaluating PROSTest, a Blood-Based Molecular Assay, for Risk Stratification and Biopsy Decision Support in Men With Suspected Prostate Cancer
Sponsor: Wren Laboratories LLC
View on ClinicalTrials.gov
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.
Key Details
Gender
MALE
Age Range
45 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
1500
Start Date
2026-03-15
Completion Date
2027-06-01
Last Updated
2026-03-06
Healthy Volunteers
No
Interventions
DIAGNOSTIC_TEST
PROSTEST
BLOOD SAMPLE FOR PROSTEST MEASUREMENT
Locations (1)
Wren Laboratories
Branford, Connecticut, United States