MRI Screening in Men at High Risk of Developing Prostate Cancer

NCT ID: NCT05608694

Last Updated: 2025-01-31

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-02

Study Completion Date

2039-03-01

Brief Summary

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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

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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.

Conditions

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Prostate Cancer Screening

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SCREENING

Blinding Strategy

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.

Group Type OTHER

Prostate MRI

Intervention Type OTHER

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.

Group Type OTHER

Prostate MRI

Intervention Type OTHER

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).

Group Type OTHER

Prostate MRI

Intervention Type OTHER

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.

Group Type OTHER

Prostate MRI

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

NorthShore University Health System - Glenbrook Hospital

Glenview, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Scott Eggener, MD

Role: CONTACT

7737021001

Teresa Barry

Role: CONTACT

Facility Contacts

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Scott Eggener, MD

Role: primary

773-702-1001

Teresa Barry

Role: backup

7737025681

Pooja Talaty

Role: primary

Svetlana Brumer

Role: backup

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.

Reference Type BACKGROUND
PMID: 38576242 (View on 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.

Reference Type BACKGROUND
PMID: 39321360 (View on 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.

Reference Type BACKGROUND
PMID: 38648061 (View on PubMed)

Other Identifiers

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IRB20-0038

Identifier Type: -

Identifier Source: org_study_id

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