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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05608694
Other study ID # IRB20-0038
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 2, 2022
Est. completion date March 1, 2039

Study information

Verified date February 2024
Source University of Chicago
Contact Scott Eggener, MD
Phone 7737021001
Email seggener@surgery.bsd.uchicago.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date March 1, 2039
Est. primary completion date March 1, 2037
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 - Prostate biopsy done within last 3 years - Prostate MRI done within last 3 years

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Prostate MRI
Group placement is determined by GRS score, Family history, and germline testing

Locations

Country Name City State
United States University of Chicago Chicago Illinois
United States NorthShore University Health System - Glenbrook Hospital Glenview Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with high grade prostate cancer detection. MRI results will be collected every 3 years for 15 years until high grade prostate cancer is detected as defined as Gleason greater than or equal to 7 (Grade Group 2). Every 3 years up to 15 years
See also
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