Utilization of Educational Interventions in Completion of Genetic Testing in Black Patients With High-Risk Prostate Cancer
Recruiting · NCT05958082 · Interventional (participants receive a specific treatment) · Lead sponsor: Henry Ford Health System
View the official record on ClinicalTrials.gov →Interventions studied
Educational video
What this trial is about
This is a pilot study to improve rates of germline genetic testing for black patients with aggressive prostate cancer as recommended by the updated guidelines by the National Cancer Comprehensive Network (NCCN) in 2018. In this study, consented patients will undergo a low-risk intervention of an educational session with a trained staff member on germline testing in prostate cancer and, if agreeable, subsequent germline cancer genetic testing via a commercial lab test.
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
- Men, age greater than or equal to 18 years of age.
- Men who racially identify as black or multiracial including black
- Diagnosis of prostate cancer of any histology.
- Must meet NCCN guidelines for germline testing
- 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
- 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
- Have had prior germline testing.
- Have somatic genetic testing that is positive for a possible germline variant.
Where it is running
1 location listed across 1 US state.
- Henry Ford Cancer Pavilion - Detroit, Michigan, United States