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NCT Number: NCT05608694

MRI Screening in Men at High Risk of Developing Prostate Cancer

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.

Recruiting

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Key information

Conditions

Prostate Cancer Screening

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prostate MRI

Other

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

Primary outcomes

  1. Proportion of patients with high grade prostate cancer detection.

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Scott Eggener, MD

CONTACT

[email protected]

7737021001

Teresa Barry

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2022
Primary completion
2037
Study completion
2039
First posted
Nov 8, 2022
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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