Improving genetic testing rates in Black patients with high-risk prostate cancer
Utilization of Educational Interventions in Completion of Genetic Testing in Black Patients With High-Risk Prostate Cancer
This study is trying to see if one-on-one education can help Black patients with aggressive prostate cancer get more genetic testing done.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Henry Ford Health System Academic / other |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT05958082 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to enhance the completion rates of germline genetic testing among Black patients diagnosed with aggressive prostate cancer, following updated guidelines from the National Comprehensive Cancer Network. Participants will receive a one-on-one educational session led by a trained coordinator, focusing on the importance and implications of genetic testing. After the session, patients will have the option to undergo germline testing through a commercial lab if they consent. The study also includes assessments of patient understanding and satisfaction regarding the educational intervention.
Who should consider this trial
Good fit: Ideal candidates are Black men aged 18 and older with a diagnosis of prostate cancer who meet the NCCN guidelines for germline testing.
Not a fit: Patients who do not identify as Black or multiracial, or those who do not meet the NCCN criteria for genetic testing, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly increase the rates of genetic testing in Black patients, leading to better-informed treatment decisions and personalized care.
How similar studies have performed: While this approach is focused on a specific demographic and condition, similar educational interventions have shown promise in improving testing rates in other populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Men, age greater than or equal to 18 years of age.
2. Men who racially identify as black or multiracial including black
3. Diagnosis of prostate cancer of any histology.
4. Must meet NCCN guidelines for germline testing
1. Men with very low, low or intermediate risk prostate per NCCN guidelines with a positive family history or intraductal histology. Family history here is considered significant if the patient has:
* a first degree relative with prostate cancer or more than one first/second degree relative with prostate cancer, or
* ≥3 cancers on same side of family, especially diagnoses ≤50 years of age: bile duct, breast, colorectal, endometrial, gastric, kidney, melanoma, ovarian, pancreatic, prostate (but not clinically localized Grade Group 1), small bowel, or urothelial cancer
2. Men with high-risk, very-high risk (per NCCN definitions of risk groups), lymph node positive, or metastatic prostate cancer independent of family history of histology.
Exclusion Criteria:
1. Have had prior germline testing.
2. Have somatic genetic testing that is positive for a possible germline variant.
Where this trial is running
Detroit, Michigan
- Henry Ford Cancer Pavilion — Detroit, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Clara Hwang, MD
- Email: chwang2@hfhs.org
- Phone: 313-556-8830
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.