Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study

Study Overview
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Brief Summary
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This trial studies the role of inherited (present at birth) mutations in cancer risk genes such as BRCA2, BRCA1, ATM, CHEK2, and others in relation to prostate cancer. This study may help researchers understand the frequency and importance of inherited mutations in cancer risk genes in patients with prostate cancer and potentially help identify better ways to treat cancer in patients who have a mutation in one of these genes.

Detailed Description
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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.

Official Title
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Genetic Information to Inform Treatment and Screening (GIFTS) Study for Prostate Cancer

Conditions
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Prostate Carcinoma

Intervention / Treatment
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* Behavioral: Questionnaire
* Procedure: Biospecimen Collection
* Diagnostic Test: Genetic Testing
* Other: Genetic Counseling
* Other: Laboratory Biomarker Analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case Ascertainment<br>Men with prostate cancer | Behavioral: Questionnaire<br>* Complete questionnaire<br>* Other names: Questionnaires;Procedure: Biospecimen Collection<br>* Provide saliva samples<br>* Other names: Specimen Collection;Diagnostic Test: Genetic Testing<br>* Undergo genetic testing<br>* Other names: Genetic Test;Other: Genetic Counseling<br>* Undergo counseling<br>Other: Laboratory Biomarker Analysis<br>* Correlative Studies<br>|
| Family Recruitment<br>Male relatives of men with prostate cancer | Behavioral: Questionnaire<br>* Complete questionnaire<br>* Other names: Questionnaires;Procedure: Biospecimen Collection<br>* Provide saliva samples<br>* Other names: Specimen Collection;Diagnostic Test: Genetic Testing<br>* Undergo genetic testing<br>* Other names: Genetic Test;Other: Genetic Counseling<br>* Undergo counseling<br>Other: Laboratory Biomarker Analysis<br>* Correlative Studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of a population-based cohort of men with prostate cancer (PC) and germline deoxyribonucleic acid (DNA) repair gene (gDRG) mutations | 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 prostate cancer. | From the start of study through death (up to 20 years) | 
| Clinical, pathologic, and molecular predictors of gDRG mutation carriers for men with PC | 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. | From the start of study through death (up to 20 years) | 
| Utility and feasibility of cascade genetic testing through use of family history of men with PC identified to have gDRG mutations | To be determined by collection of information about participants' family history and subsequent analysis of cascade genetic testing outcomes. | From the start of study through death (up to 20 years) | 
| Identification of a cohort of men with gDRG mutations without PC | Identification to be determined through family history of men with PC 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 prostate cancer. | From the start of study through death (up to 20 years) |