MRI Screening in Men at High Risk of Developing Prostate Cancer

Not Applicable

Recruiting

• Conditions: Prostate Cancer Screening
• Interventions: Other: Prostate MRI

• Registration Number: NCT05608694
• Lead Sponsor: University of Chicago

Brief 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.

Study Timeline

• Study Start: 2022-03-02
• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-31
• Primary Completion: 2037-03-01
• Study Completion: 2039-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
High Risk- Positive Germline Mutation (n=40):	Prostate MRI	Men who harbor known germline mutations that have been associated with an increased risk of prostate cancer and aggressive disease (e.g. BRCA2, ATM, PALB2, etc.) with or without a known family history of prostate cancer.
Low Risk (n=125):	Prostate MRI	No known germline mutation, low genetic risk score (GRS \<1.5), and no known family history of prostate cancer.
High Risk- High GRS (n=40):	Prostate MRI	Men who harbor significantly increased disease risk based upon genetic risk score (GRS) value \>1.5 with or without a known family history of prostate cancer.
High Risk- Family History (n=45):	Prostate MRI	Men with a family history of prostate cancer in at least one sibling, father, uncle, or grandfather but no known increased genetic risk of prostate cancer (has no pathogenic or likely pathogenic mutation along with a low genetic risk score (GRS\<1.5).

Primary Outcome Measures

Name	Time	Method
Proportion of patients with high grade prostate cancer detection.	Every 3 years up to 15 years	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).

Trial Locations

Locations (2)

NorthShore University Health System - Glenbrook Hospital; 🇺🇸 Glenview, Illinois, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States