NCT05487846 Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation
| NCT ID | NCT05487846 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Thomas Jefferson University |
| Condition | Metastatic Prostate Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-01-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This clinical trial evaluates whether having a trained peer navigator helps African American men with prostate cancer that has spread to other parts of the body (metastatic) understand and navigate the genetic testing process better than not having a peer navigator. Genetic testing for men with prostate cancer is very important for making treatment and management decisions. However, understanding the risks, benefits, and steps of genetic counseling and testing can be very challenging for patients. African American men are especially less likely to participant in genetic testing due to lack of awareness or understanding, cultural beliefs, finances, or mistrust of the healthcare system. A peer navigator, someone who helps a patient through the information and the process, may be helpful to some men. This study evaluates whether having a peer navigator throughout the genetic evaluation process helps patients understand and engage in the process more.
Eligibility Criteria
Inclusion Criteria: * Provide signed and dated informed consent form * English speaking only * Willing to comply with all study procedures and be available for the duration of the study * Any individual \>= 18 years old * African American men who meet National Comprehensive Cancer Network (NCCN) criteria for testing will be offered participation. These criteria include any one of the following: (1) metastatic prostate cancer (PCA); (2) intraductal or ductal pathology; (3) T3a or higher; (4) grade group 4 or Gleason 8 or higher; (5) family history of breast, ovarian, prostate, pancreatic, colorectal, or uterine cancers in 3 or more blood relatives particularly if diagnosed at age \< 50. These criteria have been adapted from the NCCN Prostate Cancer (version 2.2021) and NCCN Breast, Ovarian, and Pancreatic (version 2.2021) guideline Exclusion Criteria: * Patients that do not meet the inclusion criteria and children under the age of 18 will be excluded * Anyone who has trouble understanding the consent or with significant anxiety detected during the consent process will also be excluded
Contact & Investigator
Amy Leader, DrPH, MPH
PRINCIPAL INVESTIGATOR
Thomas Jefferson University
Frequently Asked Questions
Who can join the NCT05487846 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Metastatic Prostate Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05487846 currently recruiting?
Yes, NCT05487846 is actively recruiting participants. Contact the research team at Amy.leader@jefferson.edu for enrollment information.
Where is the NCT05487846 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT05487846 clinical trial?
NCT05487846 is sponsored by Thomas Jefferson University. The principal investigator is Amy Leader, DrPH, MPH at Thomas Jefferson University. The trial plans to enroll 120 participants.