Recruiting

Genetic Testing

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07197723

Conditions

BRCA1/2

Geneitic Testing

Eligibility Criteria

Sex: Male

Age: 45 - 70

Healthy Volunteers: Not accepted

Interventions

cheek (buccal) swab

Assessments

optional collection of blood

Study Details

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

Study ID

NCT07197723

Start date

Sep 25, 2025

Status verified date

Jul, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 45 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Documentation of Disease

o Patients must not have prostate cancer (for individuals not presently receiving care at the study site, this information will be based on self-report.)
  • Age between 45 - 70;
  • Assigned male sex at birth for individuals not presently receiving care at the study site, this information will be based on self-report.)
  • 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.(for individuals not presently receiving care at the study site, this information will be based on self-report.)

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) (for individuals not presently receiving care at the study site, this information will be based on self-report.)
  • Enrolled in NCI study 19-C-0040 (Natural History of Men at High-Risk for Prostate Cancer) based on self-report
  • Patients with a known pathogenic and/or likely pathogenic germline variant in any hereditary prostate cancer risk gene, excluding BRCA1 and/or BRCA2, including but not limited to: HOXB13, ATM, CHEK2, NBN, PALB2, MLH1, MSH2, MSH6, PMS2,RAD51C, RAD51D and TP53.
  • Any patient who has had a prostate biopsy within 36 months, according to clinician note (for individuals not presently receiving care at the study site, this information will be based on self-report)

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jada Hamiliton, PhD, MPH

646-888-0049hamiltoj@mskcc.org

Kenneth Offit, MD

646-888-4050

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Jada Hamilton, PhD, MPH

646-888-0049

Kenneth Offit, MD

646-888-4050

Principal Investigator:

Jada Hamilton, PhD, MPH

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • Polygenic Risk Modifiers
  • BRCA1/2 Mutation Carriers
  • Assessments

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-07-10.