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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
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

NCT07454603

RecruitingN/A

Sponsor: Wren Laboratories LLC

Conditions: Prostate Cancer, Urology, Prostate Cancer (Diagnosis)

Interventions: PROSTEST

Countries: United States

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.

Eligibility overview

Sex: MALE

Age: 45 Years to 80 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

* elevated PSA and/or abnormal digital rectal examination

Exclusion Criteria:

* Previous Prostate cancer diagnosis
Locations (1)
  • Branford, Connecticut, United States