EDRN Prostate MRI Biomarker Study

NCT03784924 | Recruiting

• 1 other identifier: 430
• Study Type: observational
• Target: 950
• Locations: 1 country
• Sites: 1

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.

Conditions

PSA; Prostate Cancer

Keywords

Prostate cancer; psa; early detection; MRI

Outcome Measures

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

  2 years

Study Arms (1)

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

Interventions

MRI prostate DIAGNOSTIC_TEST

MRI and laboratory biomarkers

Also known as: urine and blood biomarkers

Initial prostate biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Urology clinics

You may qualify if:

• Men with suspected but undiagnosed prostate cancer
• To be scheduled/scheduled for biopsy as routine clinical care

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• 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
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

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 5.0ml Unprocessed Raw Urine 4 x 5.0ml Whole Urine 4 x 5ml Supernatant 1 x 50ul Pellet/Sediment FFPE tumor tissue (blocks) from all cancer foci Nitrocellulose tissue prints from all cores

MeSH Terms

Conditions

Prostatic Neoplasms; Salivary Gland Adenoma, Pleomorphic

Interventions

Urination

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• John T Wei, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jackie Dahlgren

CONTACT

206-667-3438; jdahlgre@fredhutch.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David A Bloom Professor of Urology, Medical Director of Brighton Center for Specialty Care and Professor of Urology, Medical School

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 24, 2018
• Study Start: February 4, 2019
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)