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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03784924
Other study ID # 430
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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