Actively Recruiting
Effect of Polygenic Risk Modifiers on Decisions of BRCA1/2 Mutation Carriers at Risk for Prostate Cancer
Led by Memorial Sloan Kettering Cancer Center ยท Updated on 2026-04-22
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
C
CureBRCA Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to learn how men with BRCA1/2 genetic mutations make decisions about their health care, particularly regarding prostate cancer screening. The study focuses on how genetic risk modifier testing influences participants' thoughts and feelings about their cancer risk. Participants are men aged 45 to 70 who carry BRCA1/2 mutations but do not have prostate cancer and are fluent in English, as the surveys are only available in English. Participants will be offered genetic risk modifier testing through cheek (buccal) swabs, which can be done in person or at home using a mailed test kit. They will complete surveys at baseline and then again at about 1 week, 6 months, and 12 months after receiving their test results. Optional blood samples may also be collected for research testing. The genetic testing is of clinical grade but is not yet standard care and is provided only within this research context. During the study, participants will complete the CGS Family History Questionnaire after their baseline assessment, which helps inform genetic counselors and doctors when disclosing test results. Researchers will monitor participants' intention to undergo prostate cancer screening over six months and assess psychological and behavioral outcomes through follow-up surveys. The total follow-up period extends to 12 months after receiving genetic risk modifier results.
CONDITIONS
Brief Title
Study of How People Make Decisions About Prostate Cancer Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men aged 45 to 70 years
- Assigned male sex at birth
- Confirmed BRCA1 or BRCA2 likely pathogenic or pathogenic genetic variant by clinical genetic testing or documented clinician note
- No diagnosis of prostate cancer
- Able to communicate in English to complete surveys
You will not qualify if you...
- Major psychiatric illness or cognitive impairment preventing participation
- Unable to comply with study procedures
- Currently undergoing active treatment for any cancer
- Enrolled in NCI study 19-C-0040 (Natural History of Men at High-Risk for Prostate Cancer)
- Pathogenic variants in cancer predisposition genes other than BRCA1/2 confirmed by genetic testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Up to 1 week
Participants provide a cheek swab sample either in person or at home using a mailed test kit and complete baseline assessments including family history questionnaires.
1 visit (in-person or remote) plus at-home sample collection
Duration - 12 months
Participants complete additional surveys about their psychological and behavioral outcomes at multiple time points after receiving their genetic risk modifier results.
3 surveys at approximately 1 week, 6 months, and 12 months post-results
Duration - Flexible timing within the study period
Participants may choose to provide blood samples for research testing purposes.
1 optional visit for blood collection
Trial Site Locations
Total: 1 location
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
J
Jada Hamiliton, PhD, MPH
K
Kenneth Offit, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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