MRI Screening in Men at High Risk of Developing Prostate Cancer
NCT ID: NCT05608694
Last Updated: 2025-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2022-03-02
2039-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
SCREENING
NONE
Study Groups
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High Risk- Positive Germline Mutation (n=40):
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.
Prostate MRI
Group placement is determined by GRS score, Family history, and germline testing
High Risk- High GRS (n=40):
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.
Prostate MRI
Group placement is determined by GRS score, Family history, and germline testing
High Risk- Family History (n=45):
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).
Prostate MRI
Group placement is determined by GRS score, Family history, and germline testing
Low Risk (n=125):
No known germline mutation, low genetic risk score (GRS \<1.5), and no known family history of prostate cancer.
Prostate MRI
Group placement is determined by GRS score, Family history, and germline testing
Interventions
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Prostate MRI
Group placement is determined by GRS score, Family history, and germline testing
Eligibility Criteria
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Inclusion Criteria
* No known history of prostate cancer
* No previous prostate resection or ablation (e.g. TURP, photovaporization)
Exclusion Criteria
* Lack of a rectum
* Hip arthroplasty
18 Years
MALE
No
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Scott Eggener, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago
Chicago, Illinois, United States
NorthShore University Health System - Glenbrook Hospital
Glenview, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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IRB20-0038
Identifier Type: -
Identifier Source: org_study_id
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