EDRN Prostate MRI Biomarker Study

Recruiting

• Conditions: Prostate Cancer; PSA
• Interventions: Diagnostic Test: MRI prostate

• Registration Number: NCT03784924
• Lead Sponsor: University of Michigan

Brief 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.

Study Timeline

• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-19
• Study First Posted: 2018-12-24
• Study Start: 2019-02-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-05
• Primary Completion: 2028-06-30
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 950

Inclusion Criteria

• Men with suspected but undiagnosed prostate cancer
• To be scheduled/scheduled for biopsy as routine clinical care

Exclusion Criteria

• Inability to obtain blood and urine per SOP or conduct an attentive DRE
• Unable to undergo/tolerate a prostate MRI or failure to conduct the MRI
• Prior diagnosis of prostate cancer
• Prior prostate MRI unless being used as Index MRI (in this case index MRI can be one year prior to consent date)
• Participating in clinical trial for prostate disease
• Prior prostate surgery such as TURP, TUNA, TUMT, HOLEP, REZUM, UROlift
• Prior PCA3, TMPRSS2:erg or MIPS panel performed for clinical purpose

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Initial prostate biopsy	MRI prostate	Men who have never had a prostate biopsy, but have an elevated risk for prostate cancer such as elevated PSA who are scheduled or considered candidate for an initial prostate biopsy.

Primary Outcome Measures

Name	Time	Method
Clinically significant prostate cancer	2 years	Pathologic diagnosis of prostate cancer with at least Gleason 7 or worse cancer grade on a needle biopsy

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States