MRI Screening in Men at High Risk of Developing Prostate Cancer

Study Overview
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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.

Official Title
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MRI Screening in Men at High Risk of Developing Prostate Cancer

Conditions
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Prostate Cancer Screening

Intervention / Treatment
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* Other: Prostate MRI


Participation Criteria
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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 Prostate biopsy done within last 3 years Prostate MRI done within last 3 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: High Risk- Positive Germline Mutation (n=40):<br>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. | Other: Prostate MRI<br>* Group placement is determined by GRS score, Family history, and germline testing<br>|
| Other: High Risk- High GRS (n=40):<br>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. | Other: Prostate MRI<br>* Group placement is determined by GRS score, Family history, and germline testing<br>|
| Other: High Risk- Family History (n=45):<br>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). | Other: Prostate MRI<br>* Group placement is determined by GRS score, Family history, and germline testing<br>|
| Other: Low Risk (n=125):<br>No known germline mutation, low genetic risk score (GRS <1.5), and no known family history of prostate cancer. | Other: Prostate MRI<br>* Group placement is determined by GRS score, Family history, and germline testing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Every 3 years up to 15 years |