NCT03503097

Genetic Testing for Men With Metastatic Prostate Cancer

GENTleMEN: Genetic Testing for Men With Metastatic Prostate Cancer

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 799 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Prostate Carcinoma
• Stage IV Prostate Cancer AJCC v8
• Stage IVB Prostate Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Provide saliva samples
OTHER	Genetic Counseling	Undergo counseling
OTHER	Genetic Testing	Undergo genetic testing
OTHER	Laboratory Biomarker Analysis	Correlative studies
BEHAVIORAL	Questionnaire	Complete questionnaire

Timeline

• Start date: 2017-08-21
• Primary completion: 2024-08-21
• Completion: 2025-09-17
• First posted: 2018-04-19
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States