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RecruitingObservational

Effect of Polygenic Risk Modifiers on Decisions of BRCA1/2 Mutation Carriers at Risk for Prostate Cancer

NCT ID: NCT07197723Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-04-22

Summary

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.

Arms & interventions

  • Geneticcheek (buccal) swab

    swab sample in person or at home with a mailed test kit and will fill out a survey

  • OtherAssessments

    about 1 week, 6 months, and 12 months after getting the updated cancer risk assessment to complete additional surveys.

  • Otheroptional collection of blood

    for research testing

Outcome measures

Primary

  • Intention to undergo prostate cancer screening options

    Change in intention for each screening option measured with the Choice predisposition scale. Choice Predisposition scale ranges from 1 (leaning towards yes) to 15 (leaning towards no) regarding a specific option.

    Time frame: 6 months

Eligibility criteria

Sex: MaleAge: 45 Years to 70 YearsHealthy volunteers: No
Inclusion Criteria: * Documentation of Disease 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, or clinician note documents a BRCA1/2 likely pathogenic or pathogenic variant * 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: * Major psychiatric illness or cognitive impairment that in the judgment of the study investigators or study staff would preclude study participation. * 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 * Any patients who have pathogenic or likely pathogenic variants in cancer predisposition genes other than BRCA1/2 as confirmed by germline genetic testing

Study locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
Jada Hamilton, PhD, MPH · Contact
Kenneth Offit, MD · Contact
Jada Hamilton, PhD, MPH · Principal Investigator