EDRN Prostate MRI Biomarker Study
Status
RECRUITING
Phase
Age
≥ 18 Years
Enrollments
1500Conditions
PSA, Prostate CancerSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- John T Wei, MD
- 734-615-3040
- [email protected]
Principal Investigator
- John T Wei, MD, MS
Eligibility Criteria
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 Plan
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.
DIAGNOSTIC_TEST:
MRI prostateDescription:
MRI and laboratory biomarkers
Outcome Measures
Primary Outcome Measures
Clinically significant prostate cancer
Timeline
Last Updated
February 23, 2024Start Date
December 24, 2018Today
February 5, 2025Completion Date ( Estimated )
December 31, 2028
Sponsors of this trial
Lead Sponsor
University of MichiganCollaborating Sponsors
The University of Texas Health Science Center at San Antonio, University of Alabama at Birmingham, University of Chicago, Cornell University, H. Lee Moffitt Cancer Center and Research Institute, Vanderbilt University, Emory University, University of Miami, University of Texas, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Fred Hutchinson Cancer Center
RECRUITING 
21 - 64 Years