EDRN Prostate MRI Biomarker Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorUniversity of Michigan
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Men with suspected but undiagnosed prostate cancer
To be scheduled/scheduled for biopsy as routine clinical care
Disqualifiers
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)
Trial population
Urology clinics
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MRI prostate
Diagnostic testMRI and laboratory biomarkers
Treatment groups
950 Participants
are divided into 1 treatment groupGroup A: Initial prostate biopsy1 intervention
Trial outcomes
Primary outcomes
1
Clinically significant prostate cancer
Pathologic diagnosis of prostate cancer with at least Gleason 7 or worse cancer grade on a needle biopsy
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
The University of Texas Health Science Center at San Antonio
Collaborator
University of Alabama at Birmingham
Collaborator
University of Chicago
Collaborator
Cornell University
Collaborator
H. Lee Moffitt Cancer Center and Research Institute
Collaborator
Vanderbilt University
Collaborator
Emory University
Collaborator
University of Miami
Collaborator
University of Texas
Collaborator
Beth Israel Deaconess Medical Center
Collaborator
Brigham and Women's Hospital
Collaborator
Fred Hutchinson Cancer Center
Collaborator
Source ClinicalTrials.gov