RecruitingNCT03784924
EDRN Prostate MRI Biomarker Study
EDRN Prostate MRI Biomarker Study and Reference Set
Sponsor
University of Michigan
Enrollment
950 participants
Start Date
Feb 4, 2019
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Sex: MALEMin Age: 18 Years
Inclusion Criteria2
- Men with suspected but undiagnosed prostate cancer
- To be scheduled/scheduled for biopsy as routine clinical care
Exclusion Criteria7
- 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
Interventions
DIAGNOSTIC_TESTMRI prostate
MRI and laboratory biomarkers
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03784924
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