EDRN Prostate MRI Biomarker Study (P-MRI)

EDRN Prostate MRI Biomarker Study and Reference Set

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; PSA
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Jackie Dahlgren; Phone Number: 206-667-3438; Email: jdahlgre@fredhutch.org

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: John T Wei, MD; Phone Number: 734-615-3040; Email: jtw@med.umich.edu
      • Contact: Rabia Martin; Phone Number: 7347637508; Email: rabia@med.umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Urology clinics

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: urine and blood biomarkers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically significant prostate cancer	Pathologic diagnosis of prostate cancer with at least Gleason 7 or worse cancer grade on a needle biopsy	2 years

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: University of Miami; Beth Israel Deaconess Medical Center; University of Alabama at Birmingham; University of Chicago; Emory University; Brigham and Women's Hospital; Fred Hutchinson Cancer Center; Vanderbilt University; University of Texas; The University of Texas Health Science Center at San Antonio; H. Lee Moffitt Cancer Center and Research Institute; Cornell University
• Investigators: Principal Investigator: John T Wei, MD, MS, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2019
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: MRI; early detection; Prostate cancer; psa
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 430

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No