Clinical trial · Observational
Genetic Testing for Men With Metastatic Prostate Cancer
GENTleMEN: Genetic Testing for Men With Metastatic Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study closed to accrual before meeting enrollment goal due to end of funding.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Stage IVB Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Genetic Counseling | Other | — | UNRESOLVED |
| Genetic Testing | Other | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-Correlative (questionnaires, Color kit, counseling)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Genetic Counseling
- Other: Genetic Testing
- Other: Laboratory Biomarker Analysis
- Behavioral: Questionnaire
Primary outcomes (4)
- measure
- Frequency of pathogenic germline homologous recombination (HR) variants in men with metastatic prostate cancer (mPC)
- timeFrame
- From the start of study up to 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available