Genetic Testing for Men With Metastatic Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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GENTleMEN: Genetic Testing for Men With Metastatic Prostate Cancer

Conditions
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Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Other: Genetic Counseling
* Other: Genetic Testing
* Other: Laboratory Biomarker Analysis
* Behavioral: Questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ancillary-Correlative (questionnaires, Color kit, counseling)<br>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 DNA repair gene. All participants have access to phone-based genetic counseling whether or not they are not found to have a mutation. | Procedure: Biospecimen Collection<br>* Provide saliva samples<br>Other: Genetic Counseling<br>* Undergo counseling<br>Other: Genetic Testing<br>* Undergo genetic testing<br>* Other names: Genetic Test;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Behavioral: Questionnaire<br>* Complete questionnaire<br>* Other names: Questionnaires;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | From the start of study up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, metastatic, genetic testing, cancer risk, BRCA1, BRCA2