Study of How People Make Decisions About Prostate Cancer Risk

NCT07197723 | Recruiting

• 1 other identifier: 25-235
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

BRCA1/2; Geneitic Testing

Keywords

Polygenic Risk Modifiers; BRCA1/2 Mutation Carriers; Assessments

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (1)

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.

Genetic: cheek (buccal) swab; Other: Assessments; Other: optional collection of blood

Interventions

cheek (buccal) swab GENETIC

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

Men with BRCA1/2 mutations who are at risk for prostate cancer

Assessments OTHER

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

Men with BRCA1/2 mutations who are at risk for prostate cancer

optional collection of blood OTHER

for research testing

Men with BRCA1/2 mutations who are at risk for prostate cancer

Eligibility Criteria

• Age: 45 Years - 70 Years
• Gender Eligibility Details: Prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants (i.e., male MSK patients with a documented BRCA1/2 PV) will be identified by study staff who will screen relevant clinic schedules (e.g., for the MSK CATCH high-risk screening clinic, for post-test visits in the MSK CGS) and approached by their clinician (primary genetic counselor, and/or clinician in the high-risk screening clinic or other MSK clinician) with support from study staff.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• CureBRCA Foundation: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

cheek (buccal) swab

Study Officials

• Jada Hamilton, PhD, MPH

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jada Hamiliton, PhD, MPH

CONTACT

646-888-0049; hamiltoj@mskcc.org

Kenneth Offit, MD

CONTACT

646-888-4050

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: September 29, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)