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Recruiting

NCT Number: NCT07197723

Study of How People Make Decisions About Prostate Cancer Risk

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.

Recruiting

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Key information

Age range

45 year–70 year

Sex eligibility

Male

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Location status: Recruiting

Location contact

Jada Hamilton, PhD, MPH

CONTACT

646-888-0049

Jada Hamilton, PhD, MPH

PRINCIPAL_INVESTIGATOR

Kenneth Offit, MD

CONTACT

646-888-4050

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

cheek (buccal) swab

Genetic

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

Assessments

Other

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

optional collection of blood

Other

for research testing

Primary outcomes

  1. Intention to undergo prostate cancer screening options

    Time frame: 6 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jada Hamiliton, PhD, MPH

CONTACT

[email protected]

646-888-0049

Kenneth Offit, MD

CONTACT

646-888-4050

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • CureBRCA Foundation

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 29, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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