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Trial Title:
MRI Screening in Men at High Risk of Developing Prostate Cancer
NCT ID:
NCT05608694
Condition:
Prostate Cancer Screening
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Prostate MRI
Description:
Group placement is determined by GRS score, Family history, and germline testing
Arm group label:
High Risk- Family History (n=45):
Arm group label:
High Risk- High GRS (n=40):
Arm group label:
High Risk- Positive Germline Mutation (n=40):
Arm group label:
Low Risk (n=125):
Summary:
The purpose of this study is to determine whether or not Magnetic Resonance Images (MRI)
will identify high-grade cancers earlier and more frequently in men at high risk of
developing prostate cancer.
Detailed description:
In this study the study team hypothesizes MR images will identify high-grade cancers
earlier and more frequently in men at high risk of developing prostate cancer. Subjects
will receive gadolinium (intravenous contrast agent) as part of their research MRI exam.
While the deposition of gadolinium (Gd) has been demonstrated in numerous studies, the
clinical consequences of Gd deposition are unknown. Gd enhanced MRI scans provide crucial
medical information regarding prostate and prostate cancer imaging and contrast-enhanced
images are a component of all guidelines and the PIRADS scoring system. The study team
will compare baseline prostate MR images of men at high risk of developing prostate
cancer to those without an identifiable predisposition and evaluate the role of a GRS in
screening men with at elevated risk of being diagnosed with prostate cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male age 18 and older
- No known history of prostate cancer
- No previous prostate resection or ablation (e.g. TURP, photovaporization)
Exclusion Criteria:
- Unable to tolerate MRI due to metal fragments or claustrophobia
- Lack of a rectum
- Hip arthroplasty
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Chicago
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Contact:
Last name:
Scott Eggener, MD
Phone:
773-702-1001
Email:
seggener@surgery.bsd.uchicago.edu
Contact backup:
Last name:
Teresa Barry
Phone:
7737025681
Email:
tbarry@bsd.uchicago.edu
Facility:
Name:
NorthShore University Health System - Glenbrook Hospital
Address:
City:
Glenview
Zip:
60026
Country:
United States
Status:
Recruiting
Contact:
Last name:
Pooja Talaty
Email:
ptalaty@northshore.org
Contact backup:
Last name:
Svetlana Brumer
Email:
sbrumer@northshore.org
Investigator:
Last name:
Brian Helfand, MD
Email:
Principal Investigator
Start date:
March 2, 2022
Completion date:
March 1, 2039
Lead sponsor:
Agency:
University of Chicago
Agency class:
Other
Source:
University of Chicago
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05608694
