Metastatic Prostate CarcinomaNCT05487846
Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation
A study testing Patient Navigation, Genetic Counseling and Survey Administration in people with Metastatic Prostate Carcinoma and Stage III Prostate Cancer AJCC v8, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Carcinoma, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
- What is being tested?
- Patient Navigation, Genetic Counseling and Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Amy Leader, DrPH, MPH, 215-955-7739, amy.leader@jefferson.edu
Amy Leader
About this study
Official title: ADVANTAGE: Addressing Disparities for Veterans and African Americans Through Peer-Navigation for Testing and Genetic Evaluation
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Develop a peer-based navigation program for African American (AA) men with prostate cancer (PCA).
II. Conduct a pilot study of peer-navigated genetic evaluation vs. standard clinical care and assess feasibility of peer navigation.
SECONDARY OBJECTIVE:
- Evaluating the intervention effects on decisional conflict and PCA genetics knowledge.
EXPLORATORY OBJECTIVE:
- Assessing trust of the healthcare system and satisfaction with the genetic evaluation process.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive assistance from a peer navigator during genetic evaluation processes. Peer navigators help patients schedule counseling appointments, discuss questions and concerns about testing, assist in saliva collection, schedule a post-test disclosure visit, and do a results and recommendations debrief.
ARM II: Patients receive standard care during genetic evaluation processes. Patients receive genetic counseling, undergo genetic testing, schedule a post-test disclosure visit, and receive their genetic test results and recommendations per standard care.
- Conditions
- Metastatic Prostate Carcinoma, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
- Being tested
- Patient Navigation, Genetic Counseling, Survey Administration, Best Practice
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigationBehavioural
Also called Patient Navigator Program
Receive peer navigation services
Genetic CounselingOther
Receive genetic counseling
Survey AdministrationOther
Ancillary studies
Best PracticeOther
Also called standard of care, standard therapy
Receive standard care
Genetic CounselingOther
Receive genetic counseling
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (peer navigation) | Experimental | Patients receive assistance from a peer navigator during genetic evaluation processes. Peer navigators help patients schedule counseling appointments, discuss questions and concerns about testing, assist in sample collection, schedule a post-test disclosure visit, and do a results and recommendations debrief. Receives: Behavioral: Patient Navigation; Other: Genetic Counseling; Other: Survey Administration |
| Arm II (best practice) | Active comparator | Patients receive standard care during genetic evaluation processes. Patients receive genetic counseling, undergo genetic testing, schedule a post-test disclosure visit, and receive their genetic test results and recommendations per standard care. Receives: Other: Best Practice; Other: Genetic Counseling; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of pretest genetic counseling engagement
Compared between randomized study groups. Tested using a chi-square test. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time.
Measured: Up to 4 years
Secondary outcomes (2)
Mean changes in decisional conflict for genetic testing
Compared between study groups over time. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time. Evaluated using mixed effects models with fixed effects for group indicator, time, and group-by-time interaction and random intercept effects for individual.
Measured: Up to 4 years
Mean changes in knowledge of cancer genetics
Compared between study groups over time. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time. Evaluated using mixed effects models with fixed effects for group indicator, time, and group-by-time interaction and random intercept effects for individual.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Jan 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Leader, DrPH, MPH, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487846
- Sponsor's protocol ID
- 21F.686
- Other IDs
- JT 17263, PC200282
- Status last verified
- Oct 2026
- First submitted
- 2 Aug 2022
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No