Recruiting

Genetic Testing

Sponsor:

Henry Ford Health System

Code:

NCT05958082

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Educational video

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT05958082

Start date

Jan 1, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Educational intervention

Patients will be asked questions about genetic testing for prostate cancer before and after an educational intervention.

Interventions

Educational video

The educational intervention will occur with a clinical research coordinator who will be trained to educate on germline testing in prostate cancer.

Primary outcome measure

  • Testing rate [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Locations

Henry Ford Cancer Pavilion

Recruiting

Detroit, Michigan, United States, 48202

Contacts

More Information

Sponsor

Henry Ford Health System

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

  • genetic testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2026-07-15.