Genetic Testing for Men With Metastatic Prostate Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/8/2018 |
| Start Date: | August 21, 2017 |
| End Date: | August 21, 2020 |
GENTleMEN: Genetic Testing for Men With Metastatic Prostate Cancer
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.
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.
PRIMARY OBJECTIVES:
I. To assess the frequency of pathogenic germline homologous recombination (HR) variants in
men with metastatic prostate cancer (mPC).
II. To collect patient reported outcome measures associated with genetic testing in men with
mPC.
III. To assess the utility of family history to enrich screening of population of men with
metastatic prostate cancer for germline HRD variants.
IV. To identify a cohort of men with prostate cancer and inherited homologous recombination
deficiency (HRD) mutations who might benefit from specific research and treatment
opportunities and provide a mechanism to notify these men of current and future
opportunities.
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.
I. To assess the frequency of pathogenic germline homologous recombination (HR) variants in
men with metastatic prostate cancer (mPC).
II. To collect patient reported outcome measures associated with genetic testing in men with
mPC.
III. To assess the utility of family history to enrich screening of population of men with
metastatic prostate cancer for germline HRD variants.
IV. To identify a cohort of men with prostate cancer and inherited homologous recombination
deficiency (HRD) mutations who might benefit from specific research and treatment
opportunities and provide a mechanism to notify these men of current and future
opportunities.
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.
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
We found this trial at
1
site
Seattle, Washington 98109
Principal Investigator: Heather H. Cheng
Phone: 206-606-4368
Click here to add this to my saved trials
