Study of How People Make Decisions About Prostate Cancer Risk

Conditions

• BRCA1/2
• Geneitic Testing

Eligibility Criteria

Sex

MALE

Age

45 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• cheek (buccal) swab — GENETIC
  swab sample in person or at home with a mailed test kit and will fill out a survey
• Assessments — OTHER
  about 1 week, 6 months, and 12 months after getting the updated cancer risk assessment to complete additional surveys.
• optional collection of blood — OTHER
  for research testing

Study Details

The purpose of this study is to learn how people with BRCA1/2 mutations respond to genetic risk modifier testing. The researchers will learn more about how people make choices about their health care, including about methods to screen for prostate cancer. Researchers are also doing this study to learn about how the genetic risk modifier test affects people's thoughts and feelings.

Key Dates

Start date

Sep 25, 2025

Status verified

Apr 2026

Primary completion

Sep 30, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

150 participants (estimated)

Arms

• Arm: 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. Participants will also be asked to complete the standard CGS Family History Questionnaire, once their baseline assessment is completed. This information will be used to inform genetic counsellors/study doctors during the patients' genetic risk modifier testing results disclosure appointment.

Primary Outcome Measure

Intention to undergo prostate cancer screening options [ Time Frame: 6 months ]

Central Contacts

• Jada Hamiliton, PhD, MPH
  646-888-0049
  [email protected]
• Kenneth Offit, MD
  646-888-4050

Locations (1)

Find similar trials in New York, NY

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