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: February 20, 2024
• Sponsor: University of Washington
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): University of Washington

Study Description

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:

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 Design

• 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, 2024
• Estimated Study Completion Date: August 21, 2024

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Washington

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States, 98109

Sponsors and Collaborators

University of Washington

National Cancer Institute (NCI)

Investigators

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

More Information

• Responsible Party: University of Washington
• ClinicalTrials.gov Identifier: 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 )
• First Posted: April 19, 2018
• Last Update Posted: February 20, 2024
• Last Verified: February 2024

• 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; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases