This clinical trial studies whether genetic risk modifier testing impacts decision making for prostate cancer screening in patients with BRCA1/2 gene mutations. People with a mutation in the BRCA1 or BRCA2 gene are at increased risk for prostate cancer. However, researchers do not know exactly how much these gene mutations affect prostate cancer risk. Researchers think that a new form of genetic testing, called “genetic risk modifier testing,” may give people with BRCA1/2 gene mutations more specific prostate cancer risk estimates. These specific prostate cancer risk assessments may help the patient understand their risk of developing prostate cancer and what prostate screening tests are recommended based on their risk factor. This may impact decision making and increase prostate cancer screening in patients with BRCA1/2 gene mutations.
Additional locations may be listed on ClinicalTrials.gov for NCT07197723.
Locations matching your search criteria
United States
New York
New York
Memorial Sloan Kettering Cancer CenterStatus: Active
Contact: Jada Hamilton
Phone: 646-888-0049
PRIMARY OBJECTIVES:
I. To determine the impact of genetic risk modifier testing with a polygenic modifier panel on male BRCA1/2 pathogenic/likely pathogenic variants (PV) carriers' intentions to consider various options for prostate cancer screening and prevention.
II. To examine the effects of genetic risk modifier testing with a polygenic modifier panel on BRCA1/2 PV carriers’ additional relevant psychological outcomes.
III. To examine the impact of genetic risk modifier testing with a polygenic modifier panel on male BRCA1/2 PV carriers' uptake of risk-adapted approaches to prostate cancer screening, including variable schedules of prostate-specific antigen (PSA) testing and magnetic resonance imaging (MRI) screening.
EXPLORATORY OBJECTIVES:
I. To evaluate whether the associations between the magnitude of carriers’ genetic risk modifier test results and their intentions, psychological, and behavioral outcomes are moderated by key individual variables including numeracy, tolerance for ambiguity, individual attitudes towards health-related risks, and personal/family cancer history.
II. To promote future research on the mechanistic aspects of genetic risk modification (e.g., on homologous repair pathways), we will leverage this protocol to create a bank of blood samples for all patients recommended for biopsy for later testing with 4K or other biomarkers being utilized to risk adapt biopsy decisions in the BRCA wildtype population (note participants will need to have signed or will sign additional appropriate consents).
OUTLINE:
Patients undergo buccal swab sample collection and genetic risk modifier testing at baseline. Once genetic risk modifier testing results are available, patients meet with a genetic counselor and/or Clinical Genetics Service (CGS) physician and receive an updated cancer risk assessment based on testing results and engage in a shared decision-making discussion about various options for risk adapted approaches to prostate cancer screening. Patients may also optionally undergo blood sample collection on study.
After completion of study intervention, patients are followed up at 1 week, 6 months, and 12 months.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJada Hamilton
