Study of Decisions About Prostate Cancer Risk in Men with BRCA1/2 Mutations

This observational study aims to understand how men with BRCA1 or BRCA2 gene mutations make decisions about prostate cancer screening after receiving updated risk information. Researchers will learn about your choices regarding prostate cancer screening and how a genetic risk modifier test affects your thoughts and feelings. You can join if you are a man between 45 and 70 years old, do not have prostate cancer, and have a BRCA1/2 mutation. The study will measure your intention to undergo prostate cancer screening options after 6 months. The current recruitment status is unclear.

Study design
This is an observational study planning to enroll 150 participants. It is not a treatment study but focuses on understanding decision-making.
What's involved
You will provide a cheek swab (buccal) sample and complete surveys at about 1 week, 6 months, and 12 months. There is an optional blood collection for research testing.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for at least 12 months, with the primary outcome measured at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07197723

Study of How People Make Decisions About Prostate Cancer Risk

Recruiting
Not specifiedAges 45–70Observational
Memorial Sloan Kettering Cancer Center
~150 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:cheek (buccal) swabAssessmentsoptional collection of blood

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intention to undergo prostate cancer screening options
Measured over 6 months
BRCA1/2
Geneitic Testing
1 sites across 1 states
New York1
  • Jada Hamilton, PhD, MPH · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

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Eligibility criteria

Inclusion

Documentation of Disease
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

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)
  • Intention to undergo prostate cancer screening options6 months

    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.