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RecruitingInterventional

MRI Screening in Men at High Risk of Developing Prostate Cancer

NCT ID: NCT05608694Sponsor: University of ChicagoLast updated: 2026-03-02

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.

Arms & interventions

  • OtherProstate MRI

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

Outcome measures

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).

    Time frame: Every 3 years up to 15 years

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
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 locations (2)

University of Chicago

Chicago, Illinois, 60637

Recruiting

NorthShore University Health System - Glenbrook Hospital

Glenview, Illinois, 60026

Recruiting
Pooja Talaty · Contact
Svetlana Brumer · Contact
Brian Helfand, MD · Principal Investigator

References

  • Fazekas T, Shim SR, Basile G, Baboudjian M, Koi T, Przydacz M, Abufaraj M, Ploussard G, Kasivisvanathan V, Rivas JG, Gandaglia G, Szarvas T, Schoots IG, van den Bergh RCN, Leapman MS, Nyirady P, Shariat SF, Rajwa P. Magnetic Resonance Imaging in Prostate Cancer Screening: A Systematic Review and Meta-Analysis. JAMA Oncol. 2024 Jun 1;10(6):745-754. doi: 10.1001/jamaoncol.2024.0734.(PubMed)
  • Hugosson J, Godtman RA, Wallstrom J, Axcrona U, Bergh A, Egevad L, Geterud K, Khatami A, Socratous A, Spyratou V, Svensson L, Stranne J, Mansson M, Hellstrom M. Results after Four Years of Screening for Prostate Cancer with PSA and MRI. N Engl J Med. 2024 Sep 26;391(12):1083-1095. doi: 10.1056/NEJMoa2406050.(PubMed)
  • Bjornebo L, Discacciati A, Falagario U, Vigneswaran HT, Jaderling F, Gronberg H, Eklund M, Nordstrom T, Lantz A. Biomarker vs MRI-Enhanced Strategies for Prostate Cancer Screening: The STHLM3-MRI Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e247131. doi: 10.1001/jamanetworkopen.2024.7131.(PubMed)
MRI Screening in Men at High Risk of Developing Prostate Cancer | Cancerify