We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MRI Screening in Men at High Risk of Developing Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05608694
Recruitment Status : Recruiting
First Posted : November 8, 2022
Last Update Posted : November 8, 2022
Sponsor:
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Screening Other: Prostate MRI Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: MRI Screening in Men at High Risk of Developing Prostate Cancer
Actual Study Start Date : March 2, 2022
Estimated Primary Completion Date : March 1, 2037
Estimated Study Completion Date : March 1, 2039

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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: Prostate MRI
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.
Other: Prostate MRI
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).
Other: Prostate MRI
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.
Other: Prostate MRI
Group placement is determined by GRS score, Family history, and germline testing




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05608694


Contacts
Layout table for location contacts
Contact: Scott Eggener, MD 7737021001 seggener@surgery.bsd.uchicago.edu
Contact: Mitchell Oddo 7738348771 moddo@bsd.uchicago.edu

Locations
Layout table for location information
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Scott Eggener, MD    773-702-1001    seggener@surgery.bsd.uchicago.edu   
Contact: Mitchell Oddo    7738348771    moddo@bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT05608694    
Other Study ID Numbers: IRB20-0038
First Posted: November 8, 2022    Key Record Dates
Last Update Posted: November 8, 2022
Last Verified: November 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases