Counseling tool for Black men with metastatic prostate cancer

Developing and Testing a Patient-centered Tumor Genomic Pre-test Counseling Tool for Black or African-American Men With Metastatic Prostate Cancer

This study tests a new counseling tool to see if it helps Black men with metastatic prostate cancer understand genetic testing better and if they find it useful.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT06171139 on ClinicalTrials.gov

What this trial studies

This study aims to enhance the equitable delivery of a pre-tumor genetic testing counseling tool specifically designed for Black or African American men diagnosed with metastatic prostate cancer. It consists of two stages: the first evaluates the educational quality and content completeness of the intervention, while the second assesses its feasibility and acceptability among participants. Participants will engage with the counseling tool and provide feedback through questionnaires over a period of up to 60 days.

Who should consider this trial

Good fit: Ideal candidates are Black or African American men aged 18 and older who have metastatic prostate cancer and are considering or have declined tumor genetic testing.

Not a fit: Patients who do not identify as Black or African American or those without metastatic prostate cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve access to and understanding of tumor genetic testing for Black or African American men with metastatic prostate cancer.

How similar studies have performed: While there may be studies focusing on genetic testing in prostate cancer, this specific approach targeting Black or African American men is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

Stage 1:

1. Age 18-years-old or older
2. Identifies as Black or African American, by either chart documentation or participant self-report. Mixed-race, including Black or African American, is included.
3. Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.
4. Able to understand study procedures and to comply with them for the entire length of the study.
5. Able to understand a written information sheet and willing to verbally consent.
6. Fluent in English (reading, writing, and speaking)

Stage 2:

1. Age 18-years-old or older
2. Identifies as Black or African American, by either chart documentation or participant self-report. Mixed-race, including Black or African American, is included.
3. Metastatic prostate cancer, by either chart documentation or participant self-report. Pathology report not needed.
4. Able to understand study procedures and to comply with them for the entire length of the study.
5. Fluent in English (reading, writing, and speaking).
6. 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:

   1. Somatic DNA testing of already-collected tissue.
   2. Somatic DNA testing of tissue to be collected in the future via biopsy, surgery, or other procedure.
   3. Blood-based DNA testing to evaluate for circulating tumor DNA.
7. 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 this trial is running

San Francisco, California

• University of California — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Daniel Kwon, MD — University of California, San Francisco
• Study coordinator: Daniel Avins

Conditions Prostate Cancer; Prostate Cancer Metastatic