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MRI Screening in Men at High Risk of Developing Prostate Cancer

Primary Purpose

Prostate Cancer Screening

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prostate MRI
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Prostate Cancer Screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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 Prostate biopsy done within last 3 years Prostate MRI done within last 3 years

Sites / Locations

  • University of ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

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

High Risk- High GRS (n=40):

High Risk- Family History (n=45):

Low Risk (n=125):

Arm 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.

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.

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).

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
October 10, 2022
Last Updated
September 12, 2023
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05608694
Brief Title
MRI Screening in Men at High Risk of Developing Prostate Cancer
Official Title
MRI Screening in Men at High Risk of Developing Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2022 (Actual)
Primary Completion Date
March 1, 2037 (Anticipated)
Study Completion Date
March 1, 2039 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Risk- Positive Germline Mutation (n=40):
Arm Type
Other
Arm 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.
Arm Title
High Risk- High GRS (n=40):
Arm Type
Other
Arm 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.
Arm Title
High Risk- Family History (n=45):
Arm Type
Other
Arm 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).
Arm Title
Low Risk (n=125):
Arm Type
Other
Arm Description
No known germline mutation, low genetic risk score (GRS <1.5), and no known family history of prostate cancer.
Intervention Type
Other
Intervention Name(s)
Prostate MRI
Intervention Description
Group placement is determined by GRS score, Family history, and germline testing
Primary Outcome Measure Information:
Title
Proportion of patients with high grade prostate cancer detection.
Description
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).
Time Frame
Every 3 years up to 15 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Eggener, MD
Phone
7737021001
Email
seggener@surgery.bsd.uchicago.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Teresa Barry
Email
tbarry@bsd.uchicago.edu
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Eggener, MD
Phone
773-702-1001
Email
seggener@surgery.bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Mitchell Oddo
Phone
7738348771
Email
moddo@bsd.uchicago.edu

12. IPD Sharing Statement

Learn more about this trial

MRI Screening in Men at High Risk of Developing Prostate Cancer

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