Genetic Testing for Men With Metastatic Prostate Cancer (GENTleMEN)

February 16, 2024 updated by: University of Washington

GENTleMEN: Genetic Testing for Men With Metastatic Prostate Cancer

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Heather H. Cheng
  • Phone Number: 206-606-4368
  • Email: gentmen@uw.edu

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with metastatic prostate cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Genetic Testing
Undergo genetic testing
Other Names:
  • genetic analysis
  • Genetic Examination
  • Genetic Test
Behavioral: Questionnaire
Complete questionnaire
Other Names:
  • Questionnaires
Procedure: Biospecimen Collection
Provide saliva samples
Other: Genetic Counseling
Undergo counseling

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Cancer Institute (NCI)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2017

Primary Completion (Estimated)

August 21, 2024

Study Completion (Estimated)

August 21, 2024

Study Registration Dates

First Submitted

April 11, 2018

First Submitted That Met QC Criteria

April 11, 2018

First Posted (Actual)

April 19, 2018

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9831 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
  • NCI-2018-00533 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • RG1001545 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
  • 5P50CA097186-17 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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