P-MRI: EDRN Prostate MRI Biomarker Study

Sponsor

University of Michigan (Other)

Overall Status

Recruiting

CT.gov ID

NCT03784924

Collaborator

The University of Texas Health Science Center at San Antonio (Other), University of Alabama at Birmingham (Other), University of Chicago (Other), Cornell University (Other), H. Lee Moffitt Cancer Center and Research Institute (Other), Vanderbilt University (Other), Emory University (Other), University of Miami (Other), University of Texas (Other), Beth Israel Deaconess Medical Center (Other), Brigham and Women's Hospital (Other)

1,500

Enrollment

Location

118.9

Anticipated Duration (Months)

12.6

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

EDRN Prostate MRI Biomarker Study and Reference Set

Actual Study Start Date :

Feb 4, 2019

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2028

Arms and Interventions

Arm	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 Names: urine and blood biomarkers

Arm

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 Names:

urine and blood biomarkers

Outcome Measures

Primary Outcome Measures

Clinically significant prostate cancer [2 years]
Pathologic diagnosis of prostate cancer with at least Gleason 7 or worse cancer grade on a needle biopsy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Investigators

Principal Investigator: John T Wei, MD, MS, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

First Posted:

Dec 24, 2018

Last Update Posted:

Dec 16, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by 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

Additional relevant MeSH terms:

Prostatic Neoplasms