MRI Screening in Men at High Risk of Developing Prostate Cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05608694

Enrollment

250

Registered

2022-11-08

Start date

2022-03-02

Completion date

2039-03-01

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer Screening

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.

Interventions

OTHERProstate MRI

Group placement is determined by GRS score, Family history, and germline testing

Study design

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

United States

Contacts

CONTACTScott Eggener, MD

seggener@surgery.bsd.uchicago.edu7737021001

CONTACTTeresa Barry

tbarry@bsd.uchicago.edu

PRINCIPAL_INVESTIGATORScott Eggener, MD

University of Chicago

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026