Metastatic Prostate CarcinomaNCT05627219
Extending Prostate Genetic Awareness, Navigation, and Delivery: The EXPAND Network
An observational study of Metastatic Prostate Carcinoma and Stage IIIB Prostate Cancer AJCC v8, run by Thomas Jefferson University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metastatic Prostate Carcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
- What is being tested?
- Training and Education, Educational Intervention and Discussion
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2024to 30 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men who have experience with both prostate cancer (PCA) and genetic counseling and testing, as well as peer education or navigation experience. African American men with a history of prostate cancer or with a strong family history of prostate cancer, breast cancer, ovarian cancer, pancreatic cancer, colorectal cancer, uterine cancer, renal cancer, urothelial cancer, or upper bowel cancer.
Who may be able to join
- 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
Who cannot join
- 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
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 Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Amy Leader, DrPh, MPH, 215-600-9151, ONCTrialNow@jefferson.edu
Amy Leader, DrPh, MPH
About this study
Official title: Peer Genetic Coaches for Enhancing Genetic Testing Awareness, Navigation, and Delivery Among African American Men With Metastatic Prostate Cancer, The EXPAND Network
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Identify and train 6 African American (AA) men as peer genetic coaches (PGCs) for the Extending Prostate Genetic Awareness, Navigation, and Delivery (EXPAND) Network. (Train peer genetic coaches) II. Conduct a feasibility study of peer genetic coaching. (Provide individual coaching)
SECONDARY OBJECTIVE:
- Patient-related outcomes will include change in decisional conflict for genetic counseling, acceptability/attitude toward genetic counseling and testing, and change of genetics knowledge.
OUTLINE:
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.
- Conditions
- Metastatic Prostate Carcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
- Being tested
- Training and Education, Educational Intervention, Discussion
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training and EducationBehavioural
Undergo training and education
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention
Receive educational booklet
DiscussionProcedure or surgery
Also called Discuss
Attend discussion with peer genetic coach
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Training and Education; Other: Educational Intervention; Procedure: Discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of inquiries to the central number (feasibility)
Measured: Up to 1 year
Percent of callers screened and eligible to participate (feasibility)
Measured: Up to 1 year
Percent of eligible callers who enroll in the study (feasibility)
Measured: Up to 1 year
Percent who complete the endpoint assessment (feasibility)
Measured: Up to 1 year
Number and percent of men making genetic counseling appointments
Measured: Up to 1 year
Secondary outcomes (3)
Change in decisional conflict for genetic counseling
Reported with mean and standard deviation.
Measured: Baseline up to 1 year
Change in acceptability/attitude toward genetic counseling and testing
Reported with mean and standard deviation.
Measured: Baseline up to 1 year
Change of genetics knowledge
Reported with mean and standard deviation
Measured: Baseline up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start3 Jun 2024
- Primary completionJul 2027 (estimated)
- Study completion30 Jul 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.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 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
- NCT05627219
- Sponsor's protocol ID
- 22C.423
- Other IDs
- JT 22046
- Status last verified
- Oct 2026
- First submitted
- 16 Nov 2022
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Genetic Coaches for Enhancing Genetic Testing Awareness, Navigation, and Delivery Among African American Men With Metastatic Prostate Cancer, The EXPAND Network
- ClinicalTrials.gov ID
- NCT05627219
- Acronym / sponsor ID
- 22C.423
- Conditions
- Metastatic Prostate Carcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 25 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- Identify and train 6 African American (AA) men as peer genetic coaches (PGCs) for the Extending Prostate Genetic Awareness, Navigation, and Delivery (EXPAND) Network. (Train peer genetic coaches) II. Conduct a feasibility study of peer genetic coaching. (Provide individual coaching)
SECONDARY OBJECTIVE:
- Patient-related outcomes will include change in decisional conflict for genetic counseling, acceptability/attitude toward genetic counseling and testing, and change of genetics knowledge.
OUTLINE:
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (training, education, discussion) | – | Behavioral: Training and Education, Other: Educational Intervention, Procedure: DiscussionAIM 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men who have experience with both prostate cancer (PCA) and genetic counseling and testing, as well as peer education or navigation experience. African American men with a history of prostate cancer or with a strong family history of prostate cancer, breast cancer, ovarian cancer, pancreatic cancer, colorectal cancer, uterine cancer, renal cancer, urothelial cancer, or upper bowel cancer.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training and EducationUndergo training and education | Behavioural | Supportive care (training, education, discussion) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, InterventionReceive educational booklet | Other | Supportive care (training, education, discussion) |
| DiscussionAlso: DiscussAttend discussion with peer genetic coach | Procedure or surgery | Supportive care (training, education, discussion) |
Primary outcome
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
3 secondary outcomes
Change in decisional conflict for genetic counseling
Time frame: Baseline up to 1 year
Change in acceptability/attitude toward genetic counseling and testing
Time frame: Baseline up to 1 year
Change of genetics knowledge
Time frame: Baseline up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy Leader, DrPh, MPH principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Prostate Carcinoma and Stage IIIB Prostate Cancer AJCC v8, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Site Public Contact (215-600-9151, ONCTrialNow@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of inquiries to the central number (feasibility) (time frame: Up to 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.