Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
OUTLINE:
Participants with mPC identified through the Washington State Cancer Registry receive mail and phone invitations to participate. Participants complete a web-based or hard copy questionnaire on their health history and family history of cancer and are mailed a saliva collection kit. Saliva samples are mailed back to Color Genomics for genetic testing, and results are provided both to participants and to study researchers. Participants who are identified to have an inherited mutation in a DNA repair gene receive phone-based genetic counseling, and are also asked for permission to contact their adult male relatives. If permission is granted, those relatives receive mail and phone invitations to complete genetic testing in a similar fashion.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Case Ascertainment Men with metastatic prostate cancer |
Behavioral: Questionnaire
Complete questionnaire
Other Names:
Procedure: Biospecimen Collection
Provide saliva samples
Diagnostic Test: Genetic Testing
Undergo genetic testing
Other Names:
Other: Genetic Counseling
Undergo counseling
Other: Laboratory Biomarker Analysis
Correlative Studies
|
| Family Recruitment Male relatives of men with metastatic prostate cancer found to have a germline DNA Repair Gene mutation |
Behavioral: Questionnaire
Complete questionnaire
Other Names:
Procedure: Biospecimen Collection
Provide saliva samples
Diagnostic Test: Genetic Testing
Undergo genetic testing
Other Names:
Other: Genetic Counseling
Undergo counseling
Other: Laboratory Biomarker Analysis
Correlative Studies
|
Outcome Measures
Primary Outcome Measures
- Identification of a population-based cohort of men with mPC and germline DNA repair gene (gDRG) mutations [From the start of study up to 5 years]
Identification to be determined through the Washington State Cancer Registry and by genetic testing on saliva samples for inherited mutations in cancer risk genes such as BRCA2, BRCA1, ATM, and others in metastatic prostate cancer.
- Clinical, pathologic, and molecular predictors of gDRG mutation carriers for men with mPC [From the start of study up to 5 years]
Predictors to be identified by analyzing information provided by participants on their health history and potentially further testing or chart review on participants who consent to future contact.
- Utility and feasibility of cascade genetic testing through use of family history of men with mPC identified to have gDRG mutations [From the start of study up to 5 years]
To be determined by collection of information about participants' family history and subsequent analysis of cascade genetic testing outcomes.
- Identification of a cohort of men with gDRG mutations without mPC [From the start of study up to 5 years]
Identification to be determined through family history of men with mPC identified through the Washington State Cancer Registry and by genetic testing on saliva samples for inherited mutations in cancer risk genes such as BRCA2, BRCA1, ATM, and others in metastatic prostate cancer.
Eligibility Criteria
Criteria
Inclusion Criteria: Case Ascertainment
-
Signed informed consent form providing agreement for germline genetic testing, use and release of health and research information
-
Diagnosis of metastatic prostate cancer
-
Resident of the 13-county area of western Washington
-
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 and email address
Inclusion Criteria: Family Recruitment
-
Signed informed consent form (ICF) providing agreement for germline genetic testing, use and release of health and research information
-
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 and email address
Exclusion Criteria: Case Ascertainment
-
Unable to provide informed consent, e.g. decisional impairment
-
Prior bone marrow transplant
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | United States | 98109 |
Sponsors and Collaborators
- Fred Hutchinson Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Heather H Cheng, Fred Hutch/University of Washington Cancer Consortium
- Principal Investigator: Daniel W Lin, Fred Hutch/University of Washington Cancer Consortium
- Principal Investigator: Colin C Pritchard, Fred Hutch/University of Washington Cancer Consortium
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RG1004177
- P50CA097186
- NCI-2020-00933
- 8754