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Genetic Testing for Men With Metastatic Prostate Cancer (GENTleMEN)

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ClinicalTrials.gov Identifier: NCT03503097
Recruitment Status : Recruiting
First Posted : April 19, 2018
Last Update Posted : June 6, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Metastatic Prostate Carcinoma Stage IV Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Procedure: Biospecimen Collection Other: Genetic Counseling Other: Genetic Testing Other: Laboratory Biomarker Analysis Behavioral: Questionnaire

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the frequency of pathogenic germline homologous recombination (HR) variants in men with metastatic prostate cancer (mPC).

II. To collect patient reported outcome measures associated with genetic testing in men with mPC.

III. To assess the utility of family history to enrich screening of population of men with metastatic prostate cancer for germline HRD variants.

IV. To identify a cohort of men with prostate cancer and inherited homologous recombination deficiency (HRD) mutations who might benefit from specific research and treatment opportunities and provide a mechanism to notify these men of current and future opportunities.

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
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: GENTleMEN: Genetic Testing for Men With Metastatic Prostate Cancer
Actual Study Start Date : August 21, 2017
Estimated Primary Completion Date : August 21, 2020
Estimated Study Completion Date : August 21, 2020

Resource links provided by the National Library of Medicine


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.
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Biospecimen Retention:   Samples With DNA
Saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with metastatic prostate cancer
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503097


Locations
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Heather H. Cheng    206-606-4368    gentmen@uw.edu   
Principal Investigator: Heather H. Cheng         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
Principal Investigator: Heather Cheng Fred Hutch/University of Washington Cancer Consortium

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT03503097     History of Changes
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 )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: April 19, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018

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

Keywords provided by University of Washington:
Prostate cancer
metastatic
genetic testing
cancer risk
BRCA1
BRCA2

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases