Genetic Testing for Men With Metastatic Prostate Cancer

Active, not recruiting

• Conditions: Stage IVB Prostate Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8; Metastatic Prostate Carcinoma
• Interventions: Procedure: Biospecimen Collection; Other: Genetic Counseling; Other: Genetic Testing; Other: Laboratory Biomarker Analysis; Behavioral: Questionnaire

• Registration Number: 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 Timeline

• Study Start: 2017-08-21
• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-11
• Study First Posted: 2018-04-19
• Primary Completion: 2024-08-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-23
• Study Completion: 2025-08-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 799

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (questionnaires, Color kit, counseling)	Genetic Counseling	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.
Ancillary-Correlative (questionnaires, Color kit, counseling)	Questionnaire	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.
Ancillary-Correlative (questionnaires, Color kit, counseling)	Laboratory Biomarker Analysis	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.
Ancillary-Correlative (questionnaires, Color kit, counseling)	Biospecimen Collection	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.
Ancillary-Correlative (questionnaires, Color kit, counseling)	Genetic Testing	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.

Primary Outcome Measures

Name	Time	Method
Patient reported outcome measures associated with genetic testing in men with mPC	From the time of enrollment up to 6-month follow-up	Outcome measures to be defined by patient reported outcomes questionnaire (on-line or hard copy) at enrollment, and at 6-month follow-up.
Identification of a cohort of men with prostate cancer and inherited HRD mutations	From the start of study up to 3 years	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.
Frequency of pathogenic germline homologous recombination (HR) variants in men with metastatic prostate cancer (mPC)	From the start of study up to 3 years	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.
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	From the start of study up to 3 years	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.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States