Study of How People Make Decisions About Prostate Cancer Risk
NCT ID: NCT07197723
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2025-09-25
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Men with BRCA1/2 mutations who are at risk for prostate cancer
Will be offered genetic risk modifier testing (note that this testing is of clinical grade but is not yet standard of care and is therefore only available through the context of this research study), and will complete baseline and then 1-week, 6-month, and 12-month post-receipt of modifier results follow-up quantitative assessments of their psychological and behavioral outcomes.
cheek (buccal) swab
swab sample in person or at home with a mailed test kit and will fill out a survey
Assessments
about 1 week, 6 months, and 12 months after getting the updated cancer risk assessment to complete additional surveys.
optional collection of blood
for research testing
Interventions
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cheek (buccal) swab
swab sample in person or at home with a mailed test kit and will fill out a survey
Assessments
about 1 week, 6 months, and 12 months after getting the updated cancer risk assessment to complete additional surveys.
optional collection of blood
for research testing
Eligibility Criteria
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Inclusion Criteria
o Patients must not have prostate cancer
* Age between 45 - 70;
* Assigned male sex at birth
* Completed full sequence or targeted genetic testing with a result confirmed in a clinically approved laboratory showing a BRCA1/2 likely pathogenic or pathogenic variant identified
* English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.
Exclusion Criteria
* Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff.
* Under active treatment for a malignancy. (Patients are eligible if they have a prior history of malignancy other than prostate cancer, as long as they are not currently undergoing active treatment for the malignancy)
* Enrolled in NCI study 19-C-0040 (Natural History of Men at High-Risk for Prostate Cancer) based on self-report
45 Years
70 Years
MALE
No
Sponsors
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CureBRCA Foundation
UNKNOWN
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jada Hamilton, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Central Contacts
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Kenneth Offit, MD
Role: CONTACT
Phone: 646-888-4050
Facility Contacts
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Jada Hamilton, PhD, MPH
Role: primary
Kenneth Offit, MD
Role: backup
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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25-235
Identifier Type: -
Identifier Source: org_study_id