Genetic Testing for Men With Metastatic Prostate Cancer (GENTleMEN)

University of Washington

Status: Terminated

Conditions: Stage IV Prostate Cancer AJCC v8; Metastatic Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8

Treatments: Behavioral: Questionnaire; Procedure: Biospecimen Collection; Other: Genetic Testing; Other: Genetic Counseling; Other: Laboratory Biomarker Analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03503097

5P50CA097186-17 (U.S. NIH Grant/Contract)

9831 (Other Identifier)

RG1001545 (Other Identifier)

NCI-2018-00533 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 799 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

799 participants in 1 patient group

Ancillary-Correlative (questionnaires, Color kit, counseling)

Description:

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.

Treatment:

Other: Laboratory Biomarker Analysis

Other: Genetic Counseling

Other: Genetic Testing

Procedure: Biospecimen Collection

Behavioral: Questionnaire