Metastatic Prostate CarcinomaGENTleMENNCT03503097
Genetic Testing for Men With Metastatic Prostate Cancer
An observational study of Metastatic Prostate Carcinoma and Stage IV Prostate Cancer AJCC v8, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
- What is being tested?
- Biospecimen Collection, Genetic Counseling and Genetic Testing
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 799 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2017to 17 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Participants with metastatic prostate cancer
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Unable or unwilling to provide all of the necessary information for eligibility, e.g. decisionally impaired
- Incomplete inclusion criteria
- Study team members
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: 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.
Read the 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.
- Conditions
- Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
- Being tested
- Biospecimen Collection, Genetic Counseling, Genetic Testing, Laboratory Biomarker Analysis, Questionnaire
- Keywords
- Prostate cancer, metastatic, genetic testing, cancer risk, BRCA1, BRCA2
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Provide saliva samples
Genetic CounselingOther
Undergo counseling
Genetic TestingOther
Also called genetic analysis, Genetic Examination, Genetic Test
Undergo genetic testing
Laboratory Biomarker AnalysisOther
Correlative studies
QuestionnaireBehavioural
Also called Questionnaires
Complete questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Other: Genetic Counseling; Other: Genetic Testing; Other: Laboratory Biomarker Analysis; Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the start of study up to 3 years
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.
Measured: 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
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.
Measured: From the start of study up to 3 years
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.
Measured: From the start of study up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start21 Aug 2017
- Primary completion21 Aug 2024
- Study completion17 Sep 2025
Why it stopped: Study closed to accrual before meeting enrollment goal due to end of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 799 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Heather H. Cheng, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503097
- Sponsor's protocol ID
- 9831
- Other IDs
- NCI-2018-00533, 9831, RG1001545, 5P50CA097186-17
- Acronym
- GENTleMEN
- Status last verified
- Sep 2025
- First submitted
- 11 Apr 2018
- Last updated
- 1 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GENTleMEN: Genetic Testing for Men With Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT03503097
- Acronym / sponsor ID
- GENTleMEN / 9831
- Conditions
- Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
- Keywords
- Prostate cancer, metastatic, genetic testing, cancer risk, BRCA1, BRCA2
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study closed to accrual before meeting enrollment goal due to end of funding.
- Enrolment
- 799 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 21 Aug 2024 (actual)
- Study completion
- 17 Sep 2025 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (questionnaires, Color kit, counseling) | – | Procedure: Biospecimen Collection, Other: Genetic Counseling, Other: Genetic Testing, Other: Laboratory Biomarker Analysis, Behavioral: QuestionnaireParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with metastatic prostate cancer
Key inclusion criteria (9 listed)
- 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;
- 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
Key exclusion criteria (3 listed)
- Unable or unwilling to provide all of the necessary information for eligibility, e.g. decisionally impaired
- Incomplete inclusion criteria
- Study team members
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionProvide saliva samples | Procedure or surgery | Ancillary-Correlative (questionnaires, Color kit, counseling) |
| Genetic CounselingUndergo counseling | Other | Ancillary-Correlative (questionnaires, Color kit, counseling) |
| Genetic TestingAlso: genetic analysis, Genetic Examination, Genetic TestUndergo genetic testing | Other | Ancillary-Correlative (questionnaires, Color kit, counseling) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Ancillary-Correlative (questionnaires, Color kit, counseling) |
| QuestionnaireAlso: QuestionnairesComplete questionnaire | Behavioural | Ancillary-Correlative (questionnaires, Color kit, counseling) |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Study closed to accrual before meeting enrollment goal due to end of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather H. Cheng principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Prostate Carcinoma and Stage IV Prostate Cancer AJCC v8, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study closed to accrual before meeting enrollment goal due to end of funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.