NCT03784924

EDRN Prostate MRI Biomarker Study

EDRN Prostate MRI Biomarker Study and Reference Set

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 950 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The commercialization of MRI fusion biopsies has resulted in a dramatic increase in the use of MRI imaging for prostate cancer. How best to use MRI in the initial prostate biopsy setting given the availability of validated prostate cancer early detection markers is uncertain.This study will allow investigators to determine if prostate MRI is superior to validated panel of laboratory biomarkers (e.g. PCA3, PSA and TMPRSS2:ERG) in the initial biopsy setting.

Detailed description

The primary aim of this study is to see if the addition of prostate MRI to a panel consisting of PSA, PCA3, TMPRSS2:ERG will significantly improve specificity for high-grade prostate cancer by 10%. The subsequent exploratory aims will 1) create an optimal panel of urine, blood and tissue biomarkers that will select those cases most likely to benefit from a MRI targeted biopsy, 2) directly compare PSA and urinary biomarkers with MRI to determine which ones are value added in the setting of initial biopsy, 3) evaluate changes in these biomarkers and MRI to determine if longitudinal changes predict subsequent high-grade prostate cancer, and 4) optimize MRI imaging to improve test performance. Importantly, this study will create a unique, prospective, cohort that will become the foundational reference set for of a range of future biomarker studies.

Conditions

• PSA
• Prostate Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MRI prostate	MRI and laboratory biomarkers

Timeline

• Start date: 2019-02-04
• Primary completion: 2028-06-30
• Completion: 2028-12-31
• First posted: 2018-12-24
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States