EDRN Prostate MRI Biomarker Study

Active:	Yes
Cancer Type:	Prostate Cancer	NCT ID:	NCT03784924
Trial Phases:		Protocol IDs:	430 (primary) NCI-2020-13734
Eligibility:	18 Years and older, Male and Female	Study Type:	Other
Study Sponsor:	University of Michigan Rogel Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT03784924

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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