Prostate Cancer Clinical Trial
Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study
Summary
This research study invites men with prostate cancer that has spread to other parts of the body (metastatic prostate cancer) identified through the Washington State Cancer Registry to complete genetic testing looking for inherited genetic mutations in about 30 cancer-risk genes. Participants also fill out a survey on their health history and family history of cancer. After receiving their test results, participants who are found to have genetic mutations predisposing to higher cancer risk receive genetic counseling, and their adult male relatives are invited to complete genetic testing as well. The researchers seek to learn about factors that might predict a higher likelihood of having a mutation, to learn how best to facilitate "cascade" genetic testing for at-risk male relatives of men with metastatic prostate cancer who are found to have concerning genetic mutations, and finally, to identify men without a prostate cancer diagnosis but with high risk genetic mutations who may benefit from a more focused screening protocol for prostate cancer.
Full Description
OUTLINE:
Participants complete questionnaire over 20 minutes at baseline, then undergo collection of saliva sample for genetic testing. Participants identified to have an inherited mutation in a deoxyribonucleic acid (DNA) repair gene undergo genetic counseling. Participants whose genetic testing does not indicate an inherited mutation in a DNA repair gene receive a letter thanking them for their participation and emphasizing the importance of ongoing communication with their physician and family members about cancer risk.
Participants will be sent newsletters every year to encourage study engagement and update health questionnaires every two years.
Eligibility Criteria
Inclusion Criteria: Case Ascertainment
Signed informed consent form providing agreement for germline genetic testing, use and release of health and research information
Male aged 35 to 89 years
Diagnosis of prostate cancer
Resident of Washington state
Willing to complete a questionnaire (online or on paper) to provide basic demographic information, family cancer history, and health history
Willing and able to provide a saliva sample
United States (U.S.) mailing address
Inclusion Criteria: Family Recruitment
Signed informed consent form providing agreement for germline genetic testing, use and release of health and research information
Males aged 35 to 89 years
Willingness to complete a questionnaire (online or on paper) to provide basic demographic information, family cancer history, and health history
Willingness and ability to provide a saliva sample
U.S. mailing address
Exclusion Criteria: Case Ascertainment
Unable to provide informed consent, e.g. decisional impairment
Prior bone marrow transplant
Currently under treatment for a hematologic malignancy
Study team members
Exclusion Criteria: Family Recruitment
Unable to provide informed consent, e.g. decisional impairment
Prior bone marrow transplant
Currently under treatment for a hematologic malignancy
Study team members
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There is 1 Location for this study
Seattle Washington, 98109, United States
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