MRI Screening in Men at High Risk of Developing Prostate Cancer

Conditions

• Prostate Cancer Screening

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Prostate MRI — OTHER
  Group placement is determined by GRS score, Family history, and germline testing

Study Details

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.

Key Dates

Start date

Mar 2, 2022

Status verified

Feb 2026

Primary completion

Mar 1, 2037

Completion

Mar 1, 2039

Study Design

Enrollment

250 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

SCREENING

Arms

• Other: 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.
• Other: 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.
• Other: 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).
• Other: Low Risk (n=125):
  No known germline mutation, low genetic risk score (GRS \<1.5), and no known family history of prostate cancer.

Primary Outcome Measure

Proportion of patients with high grade prostate cancer detection. [ Time Frame: Every 3 years up to 15 years ]

Central Contacts

• Scott Eggener, MD
  7737021001
  [email protected]
• Teresa Barry
  [email protected]

Locations (2)

Find similar trials in Chicago, IL

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