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EDRN Prostate MRI Biomarker Study (P-MRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03784924
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : January 6, 2023
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
John Wei, University of Michigan

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
PSA Prostate Cancer Diagnostic Test: MRI prostate

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
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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: EDRN Prostate MRI Biomarker Study and Reference Set
Actual Study Start Date : February 4, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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 prostate
MRI and laboratory biomarkers
Other Name: urine and blood biomarkers


Outcome Measures
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Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA

8 x 250ul and 10 x 100ul Serum 10 x 200ul EDTA Plasma

1 x 500ul Buffy Coat

1 x 1ml Whole Blood from EDTA Tube 2 x 1ml Unprocessed Raw Urine 2 x 2.5ml Whole Urine 2 x 5ml Supernatant

1 x 50ul Pellet/Sediment FFPE tumor tissue (blocks) from all cancer foci Nitrocellulose tissue prints from all cores


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Urology clinics
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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784924


Contacts
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Contact: Jackie Dahlgren 206-667-3438 jdahlgre@fredhutch.org

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: John T Wei, MD    734-615-3040    jtw@med.umich.edu   
Contact: Rabia Martin    7347637508    rabia@med.umich.edu   
Sponsors and Collaborators
University of Michigan
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
Investigators
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Principal Investigator: John T Wei, MD, MS University of Michigan
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: John Wei, David A Bloom Professor of Urology, Medical Director of Brighton Center for Specialty Care and Professor of Urology, Medical School, University of Michigan
ClinicalTrials.gov Identifier: NCT03784924    
Other Study ID Numbers: 430
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: January 6, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John Wei, University of Michigan:
Prostate cancer
psa
early detection
MRI
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases