Prostate Carcinoma
Conditions
Brief summary
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
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 may also receive an educational flyer with or without a educational video regarding prostate cancer and genetic testing. Participants will be sent newsletters every year to encourage study engagement and update health questionnaires every two years.
Interventions
BEHAVIORALQuestionnaire
Complete questionnaire
PROCEDUREBiospecimen Collection
Provide saliva samples
DIAGNOSTIC_TESTGenetic Testing
Undergo genetic testing
OTHERGenetic Counseling
Undergo counseling
OTHERLaboratory Biomarker Analysis
Correlative Studies
Sponsors
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
35 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
Case Ascertainment \[Cancer Surveillance System (CSS)/Washington State Cancer Registry (WSCR)\]: * Signed informed consent form providing agreement for germline genetic and molecular testing, use release of health and research information; and * Male aged 35 to 89 years; and * Diagnosis of prostate cancer; and * Resident of Washington state at diagnosis; and * Willing to complete a questionnaire (online or on paper) to provide basic demographic information, family cancer history, and health history; and * Willing and able to provide a saliva sample; and * United States (U.S.) mailing address. Inclusion Criteria: Case Ascertainment \[UW Medical Center (UWMC)/UW Harborview Medical Center (UWHMC)\]: * Signed informed consent form providing agreement for germline genetic and molecular testing, use release of health and research information; and * Male aged 35 to 89 years; and * Diagnosis of prostate cancer; and * Self-identifies as Black, African American, or African; and * Receiving care at UWMC or UWHMC; and * Willing and able to provide a saliva sample; and * Able to provide either a U.S. mailing address or Email address or Phone number. Inclusion Criteria: Family Recruitment * Signed informed consent form providing agreement for germline genetic and molecular testing, use and release of health and research information; and * Males aged 35 to 89 years; and * Willingness to complete a questionnaire (online or on paper) to provide basic demographic information, family cancer history, and health history; and * Willing and able to provide a saliva sample; and * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of a population-based cohort of men with prostate cancer (PC) and germline deoxyribonucleic acid (DNA) repair gene (gDRG) mutations | From the start of study through death (up to 20 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 prostate cancer. |
| Clinical, pathologic, and molecular predictors of gDRG mutation carriers for men with PC | From the start of study through death (up to 20 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 PC identified to have gDRG mutations | From the start of study through death (up to 20 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 PC | From the start of study through death (up to 20 years) | 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. |
| Effectiveness of a germline genetic testing education video: Number of participants who participate in genetic testing after watching germline genetic testing video | Up to 6 months | Will determine whether patients are more likely to participate in germline genetic testing after viewing an education video about prostate cancer genetic testing. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBurcu Darst
Fred Hutch/University of Washington Cancer Consortium
PRINCIPAL_INVESTIGATORHeather H Cheng
Fred Hutch/University of Washington Cancer Consortium
PRINCIPAL_INVESTIGATORDaniel W Lin
Fred Hutch/University of Washington Cancer Consortium
PRINCIPAL_INVESTIGATORColin C Pritchard
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed