How people make decisions about prostate cancer risk

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

This study will test how men assigned male at birth aged 45–70 with BRCA1/2 mutations respond to genetic risk modifier testing and whether it changes their prostate cancer screening choices and feelings about care.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 45 Years to 70 Years
• Sex: Male
• Sponsor: Memorial Sloan Kettering Cancer Center (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT07197723 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal participants are English-speaking adults assigned male at birth, age 45–70, without prostate cancer, who have a confirmed BRCA1 or BRCA2 pathogenic or likely pathogenic variant.

Not a fit: People who already have prostate cancer, cannot complete English surveys, or have major psychiatric or cognitive impairments are unlikely to benefit from or be eligible for this study.

Why it matters

Potential benefit: If successful, findings could help clinicians tailor prostate cancer screening advice and counseling for BRCA1/2 carriers.

How similar studies have performed: There is growing research on polygenic risk modifiers for prostate cancer, but applying these tests specifically to BRCA1/2 carriers to study decision-making is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Documentation of Disease

  o Patients must not have prostate cancer
* Age between 45 - 70;
* Assigned male sex at birth
* 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.

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)
* Enrolled in NCI study 19-C-0040 (Natural History of Men at High-Risk for Prostate Cancer) based on self-report
* Any patients who have pathogenic or likely pathogenic variants in cancer predisposition genes other than BRCA1/2 as confirmed by germline genetic testing

Where this trial is running

New York, New York

• 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

Conditions BRCA1/2; Geneitic Testing; Polygenic Risk Modifiers; BRCA1/2 Mutation Carriers; Assessments