EDRN Prostate MRI Biomarker Study and Reference Set
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Michigan
- Enrollment
- 950
- Locations
- 1
- Primary Endpoint
- Clinically significant prostate cancer
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Initial prostate biopsy
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.
Intervention: MRI prostate (Diagnostic Test)
Outcomes
Primary Outcomes
Clinically significant prostate cancer
Time Frame: 2 years
Pathologic diagnosis of prostate cancer with at least Gleason 7 or worse cancer grade on a needle biopsy
Secondary Outcomes
No secondary outcomes reported
Investigators
Simpa Salami
Associate Professor of Urology, Rogel Cancer Center Associate Director, Medical School
University of Michigan