Genetic Testing for Men With Metastatic Prostate Cancer

Metastatic Prostate Carcinoma Clinical Trial

— GENTleMEN  

Official title:

GENTleMEN: Genetic Testing for Men With Metastatic Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03503097
• Other study ID #: 9831
• Secondary ID: NCI-2018-0053398
• Status: Active, not recruiting
• Start date: August 21, 2017
• Est. completion date: August 21, 2024

Study information

• Verified date: February 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 799
• Est. completion date: August 21, 2024
• Est. primary completion date: August 21, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Biospecimen Collection
Provide saliva samples

Other:
• Genetic Counseling
Undergo counseling
• Genetic Testing
Undergo genetic testing
• Laboratory Biomarker Analysis
Correlative studies

Behavioral:
• Questionnaire
Complete questionnaire

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of pathogenic germline homologous recombination (HR) variants in men with metastatic prostate cancer (mPC)	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
Primary	Patient reported outcome measures associated with genetic testing in men with mPC	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
Primary	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	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
Primary	Identification of a cohort of men with prostate cancer and inherited HRD mutations	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