RecruitingNCT07197723

Study of How People Make Decisions About Prostate Cancer Risk

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

150 participants

Start Date

Sep 25, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 45 YearsMax Age: 70 Years

Inclusion Criteria6

  • 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
  • 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 Criteria5

  • 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

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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


Locations(1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

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NCT07197723


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