Ignite Creation Date:
2024-05-06 @ 12:32 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03784924
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2018-12-04
Brief Title:
EDRN Prostate MRI Biomarker Study
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
EDRN Prostate MRI Biomarker Study and Reference Set
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
P-MRI
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 uncertainThis study will allow investigators to determine if prostate MRI is superior to validated panel of laboratory biomarkers eg PCA3 PSA and TMPRSS2ERG in the initial biopsy setting
Detailed Description:
The primary aim of this study is to see if the addition of prostate MRI to a panel consisting of PSA PCA3 TMPRSS2ERG 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None