MRI Screening in Men at High Risk of Developing Prostate Cancer

The University of Chicago

Status

Enrolling

Conditions

Prostate Cancer Screening

Treatments

Other: Prostate MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT05608694

IRB20-0038

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Non-Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

250 participants in 4 patient groups

High Risk- Positive Germline Mutation (n=40):

Other group

Description:

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.

Treatment:

Other: Prostate MRI

High Risk- High GRS (n=40):

Other group

Description:

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.

Treatment:

Other: Prostate MRI

High Risk- Family History (n=45):

Other group

Description:

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).

Treatment:

Other: Prostate MRI

Low Risk (n=125):

Other group

Description:

No known germline mutation, low genetic risk score (GRS \<1.5), and no known family history of prostate cancer.

Treatment:

Other: Prostate MRI