Study of How People Make Decisions About Prostate Cancer Risk

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Geneitic Testing; BRCA1/2

Treatments: Other: Assessments; Genetic: cheek (buccal) swab; Other: optional collection of blood

Study type: Observational

Funder types: Other

Identifiers

NCT07197723

25-235

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Male

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Men with BRCA1/2 mutations who are at risk for prostate cancer

Description:

Will be offered genetic risk modifier testing (note that this testing is of clinical grade but is not yet standard of care and is therefore only available through the context of this research study), and will complete baseline and then 1-week, 6-month, and 12-month post-receipt of modifier results follow-up quantitative assessments of their psychological and behavioral outcomes. Participants will also be asked to complete the standard CGS Family History Questionnaire, once their baseline assessment is completed. This information will be used to inform genetic counsellors/study doctors during the patients' genetic risk modifier testing results disclosure appointment.

Treatment:

Other: optional collection of blood

Genetic: cheek (buccal) swab

Other: Assessments