NCT07197723

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
14mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Sep 2025Sep 2027

First Submitted

Initial submission to the registry

September 25, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 25, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

1.9 years

First QC Date

September 25, 2025

Last Update Submit

July 9, 2026

Conditions

BRCA1/2Geneitic Testing

Keywords

Polygenic Risk ModifiersBRCA1/2 Mutation CarriersAssessments

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) swabOther: AssessmentsOther: optional collection of blood

Interventions

cheek (buccal) swabGENETIC

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
AssessmentsOTHER

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 bloodOTHER

for research testing

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

Eligibility Criteria

Age45 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstate cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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. Or non-MSK patients (e.g., community members) who are referred to the study by study clinicians.

You may qualify if:

  • 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.)

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) (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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Related Links

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

646-888-0049hamiltoj@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

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations

US(1)