This research study provides genetic testing to men with prostate cancer that has spread to other parts of the body (metastatic prostate cancer) and will look for inherited genetic mutations in about 30 cancer-risk genes. The researchers seek to learn about the participant's opinions and concerns about genetic testing, to determine if this is an acceptable way to deliver testing and to potentially help guide the participant's treatment. Neither treatment nor any decisions related to treatment will take place on this study, but researchers will share each participant's genetic testing results with that participant.
OUTLINE: Participants receive web-based or hard-copy questionnaires and saliva collection kits via mail or in person. Participants also provide saliva samples to be mailed back to Color Genomics for genetic testing once complete. Participants then receive phone-based genetic counseling if they are identified to have an inherited mutation in a deoxyribonucleic acid (DNA) repair gene. All participants have access to phone-based genetic counseling whether or not they are not found to have a mutation. After study completion, participants are followed up at 6 months.
Study Type
OBSERVATIONAL
Enrollment
799
Provide saliva samples
Undergo counseling
Undergo genetic testing
Correlative studies
Complete questionnaire
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Frequency of pathogenic germline homologous recombination (HR) variants in men with metastatic prostate cancer (mPC)
Frequency to be determined by genetic testing on saliva samples for inherited mutations in cancer risk genes such as BRCA2, BRCA1, ATM, and others in metastatic prostate cancer.
Time frame: From the start of study up to 3 years
Patient reported outcome measures associated with genetic testing in men with mPC
Outcome measures to be defined by patient reported outcomes questionnaire (on-line or hard copy) at enrollment, and at 6-month follow-up.
Time frame: From the time of enrollment up to 6-month follow-up
Utility of family history to enrich screening of participants with mPC for germline homologous recombination deficiency (HRD) variants defined by collection of information about research participants' family history
To be determined by collection of information about research participants' family history that includes cancer history (diagnosis, age of onset, treatment, etc.) but will not include identifiers of family members. This information will be used to examine which self-reported family history criteria may be associated with identification of cancer predisposition syndrome.
Time frame: From the start of study up to 3 years
Identification of a cohort of men with prostate cancer and inherited HRD mutations
Identification to be determined through the Washington state cancer registry, through mail-out to all urologists and medical oncologists in the state of Washington, and through the Seattle Cancer Care Alliance Network sites. In addition, web-based advertising and recruiting will occur more broadly through the U.S., including at partnering sites.
Time frame: From the start of study up to 3 years
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