Prostate Cancer Clinical Trial

Genetic Testing for Men With Metastatic Prostate Cancer

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Signed informed consent form (ICF) providing agreement for germline genetic testing, use and release of health and research trial information

Documented evidence of metastatic prostate cancer;

Oncologist note within 4 months
All computed tomography (CT), bone, positron emission tomography (PET) scan reports within 12 months
All prostate-specific antigen (PSA) values within 12 months
All available pathology reports from diagnosis, prostatectomy, and/or metastatic biopsy
Willingness to provide basic demographic information, family cancer history, and treatment history
Willingness and ability to complete patient reported outcomes questionnaire (on-line or hard copy) at enrollment, and at 6-month follow-up
Willingness and ability to provide saliva sample

Exclusion Criteria:

Unable or unwilling to provide all of the necessary information for eligibility, e.g. decisionally impaired
Incomplete inclusion criteria
Study team members

Study is for people with:

Prostate Cancer

Estimated Enrollment:

799

Study ID:

NCT03503097

Recruitment Status:

Active, not recruiting

Sponsor:

University of Washington

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There is 1 Location for this study

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Fred Hutch/University of Washington Cancer Consortium
Seattle Washington, 98109, United States

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

799

Study ID:

NCT03503097

Recruitment Status:

Active, not recruiting

Sponsor:


University of Washington

How clear is this clinincal trial information?

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