Recruiting

Genetic Awareness

Sponsor:

Thomas Jefferson University

Code:

NCT05627219

Conditions

Metastatic Prostate Carcinoma

Stage IIIB Prostate Cancer AJCC v8

Stage IIIC Prostate Cancer AJCC v8

Stage IV Prostate Cancer AJCC v8

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

Training and Education

Educational Intervention

Discussion

Study Details

Brief summary:

This trial evaluates whether a network of peer genetic coaches is useful for addressing disparities in genetic testing and screening among African American men with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). While genetic testing has become central to prostate cancer care, African American men are less likely seek testing due to lack of awareness, cultural beliefs, financial limitations, fear of discrimination, and mistrust in the healthcare system. A network of peer genetic coaches may help address barriers, beliefs, and needs of African American men in the community and provide navigation to increase engagement in genetic testing.

Conditions

Metastatic Prostate Carcinoma

Stage IIIB Prostate Cancer AJCC v8

Stage IIIC Prostate Cancer AJCC v8

Stage IV Prostate Cancer AJCC v8

Study ID

NCT05627219

Start date

Jun 3, 2024

Status verified date

May, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • AIM 1: Are 18 years old or older
  • AIM 1: Are able to read and speak English comfortably
  • AIM 1: Men who have experience with both prostate cancer (PCA) and genetic counseling and testing will be a priority for training, as well as men who have considerable peer education or navigation experience
  • AIM 2: Are 18 years old or older
  • AIM 2: Are African American
  • AIM 2: Are able to read and speak English comfortably
  • AIM 2: Men who meet any one of the following criteria: (1) metastatic prostate cancer; (2) prostate cancer with high-risk features (T3 or higher, Gleason 8 or higher, node positive disease); (3) with or without a diagnosis of prostate cancer with strong family history (2 or more first-degree or second-degree relatives) with prostate cancer (particularly metastatic prostate cancer or died from prostate cancer), breast cancer, ovarian cancer, pancreatic cancer, colorectal cancer, uterine cancer, renal cancer, urothelial cancer, or upper bowel cancer

Exclusion Criteria:

  • Patients that do not meet the inclusion criteria
  • Children under the age of 18
  • Anyone who has trouble understanding the consent or with significant anxiety detected during the consent process

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Supportive care (training, education, discussion)

AIM 1: Peer genetic coaches undergo training and education on study.

AIM 2: Patients receive an educational booklet and attend a discussion with a peer genetic coach on study.

Interventions

Training and Education

Undergo training and education

Educational Intervention

Receive educational booklet

Discussion

Attend discussion with peer genetic coach

Primary outcome measure

  • Number of inquiries to the central number (feasibility) [ Time Frame: Up to 1 year ]
  • Percent of callers screened and eligible to participate (feasibility) [ Time Frame: Up to 1 year ]
  • Percent of eligible callers who enroll in the study (feasibility) [ Time Frame: Up to 1 year ]
  • Percent who complete the endpoint assessment (feasibility) [ Time Frame: Up to 1 year ]
  • Number and percent of men making genetic counseling appointments [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Amy Leader, DrPh, MPH

215 955-7739amy.leader@jefferson.edu

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Amy Leader, DrPh, MPH

215 955-7739amy.leader@jefferson.edu

Principal Investigator:

Amy Leader, DrPh, MPH

More Information

Sponsor

Thomas Jefferson University

Last update posted

May 15, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2026-05-15.