How people make decisions about prostate cancer risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study enrolls English‑fluent adults assigned male at birth, aged 45–70, who carry a confirmed BRCA1 or BRCA2 pathogenic or likely pathogenic variant and do not have prostate cancer. Participants provide a cheek (buccal) swab, may optionally give a blood sample, and complete validated surveys about screening preferences, emotions, and decision-making. Researchers return genetic risk modifier results and follow participants to see how those results influence screening intentions and psychological responses over time. The study is based at Memorial Sloan Kettering Cancer Center in New York and is conducted with the CureBRCA Foundation.

Why it matters

Who can join: the full rules

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)

Where it's running

• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Jada Hamilton, PhD, MPH — Memorial Sloan Kettering Cancer Center
• Study coordinator: Jada Hamiliton, PhD, MPH
• Email: hamiltoj@mskcc.org
• Phone: 646-888-0049

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.