EDRN Prostate MRI Biomarker Study

Prostate Cancer Clinical Trial

— P-MRI  

Official title:

EDRN Prostate MRI Biomarker Study and Reference Set

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03784924
• Other study ID #: 430
• Status: Recruiting
• Start date: February 4, 2019
• Est. completion date: December 31, 2028

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: Jackie Dahlgren
• Phone: 206-667-3438
• Email: jdahlgre[@]fredhutch.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• PSA

Intervention

Diagnostic Test:
• MRI prostate
MRI and laboratory biomarkers

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (13)

Lead Sponsor	Collaborator
University of Michigan	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Cornell University, Emory University, Fred Hutchinson Cancer Center, H. Lee Moffitt Cancer Center and Research Institute, The University of Texas Health Science Center at San Antonio, University of Alabama at Birmingham, University of Chicago, University of Miami, University of Texas, Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically significant prostate cancer	Pathologic diagnosis of prostate cancer with at least Gleason 7 or worse cancer grade on a needle biopsy	2 years