Status:
RECRUITING
EDRN Prostate MRI Biomarker Study
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
The University of Texas Health Science Center at San Antonio
University of Alabama at Birmingham
Conditions:
PSA
Prostate Cancer
Eligibility:
MALE
18+ years
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 ava...
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%. Th...
Eligibility Criteria
Inclusion
- Men with suspected but undiagnosed prostate cancer
- To be scheduled/scheduled for biopsy as routine clinical care
Exclusion
- 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
Key Trial Info
Start Date :
February 4 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
950 Patients enrolled
Trial Details
Trial ID
NCT03784924
Start Date
February 4 2019
End Date
December 31 2028
Last Update
January 8 2026
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109