Genetic Testing for Men With Metastatic Prostate Cancer (GENTleMEN)

• ClinicalTrials.gov Identifier: NCT03503097
• Recruitment Status: Active, not recruiting
• First Posted: April 19, 2018
• Last Update Posted: May 13, 2024
• Sponsor: University of Washington
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): University of Washington

Tracking Information

• First Submitted Date: April 11, 2018
• First Posted Date: April 19, 2018
• Last Update Posted Date: May 13, 2024
• Actual Study Start Date: August 21, 2017
• Estimated Primary Completion Date: August 21, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 11, 2018)

• Frequency of pathogenic germline homologous recombination (HR) variants in men with metastatic prostate cancer (mPC) [ Time Frame: 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.
• Patient reported outcome measures associated with genetic testing in men with mPC [ Time Frame: 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.
• 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 [ Time Frame: 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.
• Identification of a cohort of men with prostate cancer and inherited HRD mutations [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Genetic Testing for Men With Metastatic Prostate Cancer
• Official Title: GENTleMEN: Genetic Testing for Men With Metastatic Prostate Cancer
• 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 Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Saliva

• Sampling Method: Non-Probability Sample
• Study Population: Participants with metastatic prostate cancer

Condition

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

Intervention

• Procedure: Biospecimen Collection
  Provide saliva samples
• Other: Genetic Counseling
  Undergo counseling
• Other: Genetic Testing
  Undergo genetic testing
  Other Names:

  • genetic analysis
  • Genetic Examination
  • Genetic Test
• Other: Laboratory Biomarker Analysis
  Correlative studies
• Behavioral: Questionnaire
  Complete questionnaire
  Other Name: Questionnaires

Study Groups/Cohorts

Ancillary-Correlative (questionnaires, Color kit, 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.

Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 9, 2024): 799
• Original Estimated Enrollment (submitted: April 11, 2018): 2000
• Estimated Study Completion Date: August 21, 2024
• Estimated Primary Completion Date: August 21, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03503097
• Other Study ID Numbers: 9831; NCI-2018-00533 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 9831 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ); RG1001545 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ); 5P50CA097186-17 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Washington
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Washington
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Heather H. Cheng; Fred Hutch/University of Washington Cancer Consortium

• PRS Account: University of Washington
• Verification Date: February 2024