MRI Screening in Men at High Risk of Developing Prostate Cancer

Prostate Cancer Screening Clinical Trial

Official title:

MRI Screening in Men at High Risk of Developing Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05608694
• Other study ID #: IRB20-0038
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Prostate Cancer Screening
• Prostatic Neoplasms

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

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