Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Prostate Cancer
Recruiting · NCT06171139 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, San Francisco
View the official record on ClinicalTrials.gov →Interventions studied
Counseling ToolQuestionnaires
What this trial is about
The overall goal of the study is to improve equitable delivery of pre-Tumor genetic testing (TGT) counseling tool for Black or African American men with metastatic prostate cancer and evaluating the tool for implementation.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Stage 1:
- Age 18-years-old or older
- Identifies as Black or African American, by either chart documentation or participant self-report. Mixed-race, including Black or African American, is included.
- Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Able to understand a written information sheet and willing to verbally consent.
- Fluent in English (reading, writing, and speaking)
- Stage 2:
- Age 18-years-old or older
- Identifies as Black or African American, by either chart documentation or participant self-report. Mixed-race, including Black or African American, is included.
- Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Fluent in English (reading, writing, and speaking).
- Anticipated discussion of TGT within 0-365 days of enrollment, per treating oncology provider's discretion. TGT involves the use of any cancer genetic sequencing (whether standard-of-care or part of a research protocol) via any one of the following:
- Somatic DNA testing of already-collected tissue.
- Somatic DNA testing of tissue to be collected in the future via biopsy, surgery, or other procedure.
- Blood-based DNA testing to evaluate for circulating tumor DNA.
- Able to understand a written informed consent document and willing to sign it.
Exclusion criteria
- Contraindication to any study-related procedure or assessment in either stage.
Where it is running
1 location listed across 1 US state.
- University of California - San Francisco, California, United States