Official Title
GENTleMEN: Genetic Testing for Men With Metastatic Prostate Cancer
Brief Title
Genetic Testing for Men With Metastatic Prostate Cancer
Protocol ID
NCT03503097
Lead Sponsor
University of Washington
Brief 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.
Detailed 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.
Study Period
-
Enrollment Count
799 participants
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
Filters
Metastatic Prostate Carcinoma
Stage IV Prostate Cancer AJCC v8
Stage IVB Prostate Cancer AJCC v8
TERMINATED
ADULT
OLDER_ADULT