Prostate CancerINCLUDE PCNCT07407686
Improving Engagement From Underserved Communities With Prostate Cancer Genetics Services
An observational study of Prostate Cancer, run by Royal Marsden NHS Foundation Trust.
Trial summary
Earlier work explored barriers and facilitators to accessing prostate cancer screening, particularly in underserved communities, and provided valuable insights to build upon. This study will explore perspectives on how genetic risk for prostate cancer is explained and understood through in-depth interviews with… 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
- Prostate Cancer
- What is being tested?
- Surveys and Semi-structured interviews and focus groups
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2026to 31 Dec 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 and people with prostates from the following three communities: * Black African and Black Caribbean * Transgender women and non-binary people with prostates * Reduced access to healthcare
Who may be able to join
- Men and people with prostates age 18 and above
- Those who belong to the three underserved groups; Black African and Black Caribbean Ancestry, transgender and non-binary people with a prostate and those with reduced access to healthcare
- We allow intersectionality within reason and will narratively describe any instances of these in the writeup of findings
- Those who are able to freely consent to inclusion
- Individuals with and without a lived experience of prostate cancer
Who cannot join
- To avoid exhaustion, we will only allow participation in two interview or focus groups per individual for the entirety of the study
- Those without capacity to consent to interview (capacity is assumed unless there is good reason to believe otherwise)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Elizabeth Bancroft contact
About this study
Official title: Improving the Engagement of Underserved Communities With the Prostate Cancer Genetics Service: Identifying Barriers & Facilitators and Developing Supportive Resources Using a Co-production and Collaborative Approach
Earlier work explored barriers and facilitators to accessing prostate cancer screening, particularly in underserved communities, and provided valuable insights to build upon.
This study will explore perspectives on how genetic risk for prostate cancer is explained and understood through in-depth interviews with members of underserved communities. Findings from this work, alongside earlier results, will be used to co-design clear and accessible digital educational resources in collaboration with community members and relevant charities.
Read more
Participation in cancer screening programmes in the UK varies, with differences linked to socioeconomic status, ethnicity and health literacy. Similar inequalities are seen in access to prostate cancer genetics services, indicating a need for improved engagement.
Successful integration of genetics into prostate cancer care requires clear and inclusive information about genetic testing processes, possible outcomes and interpretation of results. Currently, there are limited resources explaining genetic risk for prostate cancer in an accessible way.
Co-production with representatives from underserved communities will ensure that educational materials are understandable, relevant and acceptable to all.
Read the detailed description
There is variability in uptake of cancer screening programmes in the UK with participation affected by socioeconomic status, ethnicity \& health literacy. This lack of representation is also seen within the prostate cancer genetics service, suggesting that further work is required to promote engagement. The successful mainstream integration of genetics into prostate cancer management will require people to understand the process, potential outcomes and interpretation of results. In addition, the information provided should be inclusive.
The barriers and facilitators to accessing prostate cancer screening work commenced under a service evaluation (CCR SE1284). This project provided valuable data from underserved communities which we wish to build on. This study aims to further explore perspectives on genetic risk explanation and education in further depth using semi-structured interviews and to use these and earlier findings to co-design educational digital materials to raise awareness about prostate cancer and genetic risk measurement, in keeping with the wishes from the communities that have worked with us.
Development of educational multi-media materials:
Utilising the Medical Research Council's Complex Intervention Design Framework, we will co-design educational materials, using the data collected from community champions and relevant charities.
Evaluation of educational multi-media materials:
The co-designed education materials will undergo evaluation in a pilot phase and then again after dissemination. Methods of evaluation will be adopted to include acceptability, usability and integration into clinical practice.
There are few current resources explaining the genetic risk of prostate cancer and opportunities to participate in genetic risk studies. The study will work alongside representatives from underserved communities to ensure that educational materials developed are accessible and acceptable to all.
- Conditions
- Prostate Cancer
- Being tested
- Surveys, Semi-structured interviews and focus groups
- Keywords
- qualitative research methods, co-production, MRC Complex Intervention Developement, Health Literacy and Health Behaviour Theories, Prostate cancer screening in high risk groups, semi-structured interviews and focus groups, reflexive thematic analysis of qualitative data, Evaluation of outputs
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysOther
Up to 30 surveys with 10 of these individuals undergoing short interviews to assess the improvement of their understanding around prostate cancer
Semi-structured interviews and focus groupsOther
Up to 60 total semi-structured interviews (up to 20 per underserved group) to assess barriers and facilitators to prostate cancer screening and how they would like information to improve their understanding to be presented.
| Study group | Role | What they receive |
|---|---|---|
| Semi-structured interview participants | Up to 60 participants for semi-structured interviews, 20 from each of the following underserved groups in prostate cancer screening; Black African and Black Caribbean, transgender and non-binary with a prostate, reduced access to healthcare. Receives: Other: Surveys; Other: Semi-structured interviews and focus groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of educational materials, demonstrating that users have an increase in understanding or prostate cancer risk and symptoms as well as genetic risk.
Using surveys (before and after use of resources) and interviews to measure improvement in understanding in individuals without experience of prostate cancer.
Measured: February 2026 to August 2026
Increased representation from underserved groups in the referrals to our genetic research studies.
Using demographic data from referrals via our website to our genetic research studies
Measured: As soon as the educational materials are live, which we aim to be from June 2026, increase in referrals to our genetic research studies from under-represented groups will be measured. This will take place for 12 months.
Qualitative data such as hits to the webpage and scroll depth and how many have signed up to the genetic research studies via the website.
This is a short term measure of how effective and engaging the resources are.
Measured: These data will be collected from as soon as the webpage goes live for the subsequent 12 months.
Secondary outcomes (2)
Improved representation of underrepresented groups in our genetic risk studies.
Recruits to our genetic research studies will be screened for demographics.
Measured: Measurements of the demographics of our research participants takes place currently. Any signficant change in representation will be reported for a minimum 12 months after the webpage and resources go live.
Reduced barriers to prostate cancer screening and participation in genetic research faced by underrepresented communities
These resources will be distributed by the community champions who we have co-designed them with. These community champions have social media networks with a strong following in their respective community and they are trusted by community members. Therefore, the resources and the webpage will have a far reach within the community to encourage engagement with empowering information and to promote prostate cancer screening and participation with our genetic risk studies.
Measured: The web page will go live in July 2026 and will be a long term resource (many years), regularly updated by our team. There will also be rounds of evaluation, using surveys and interviews, with subsequent adaption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start28 Feb 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ros Eeles, Study chair, Institute of Cancer Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407686
- Sponsor's protocol ID
- 361063
- Acronym
- INCLUDE PC
- Status last verified
- Feb 2026
- First submitted
- 21 Nov 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will be no confidential data shared outside of the research team and the study participants are members of the public, not patients.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Engagement of Underserved Communities With the Prostate Cancer Genetics Service: Identifying Barriers & Facilitators and Developing Supportive Resources Using a Co-production and Collaborative Approach
- ClinicalTrials.gov ID
- NCT07407686
- Acronym / sponsor ID
- INCLUDE PC / 361063
- Conditions
- Prostate Cancer
- Keywords
- qualitative research methods, co-production, MRC Complex Intervention Developement, Health Literacy and Health Behaviour Theories, Prostate cancer screening in high risk groups, semi-structured interviews and focus groups, reflexive thematic analysis of qualitative data, Evaluation of outputs
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Feb 2026 (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.
Earlier work explored barriers and facilitators to accessing prostate cancer screening, particularly in underserved communities, and provided valuable insights to build upon.
This study will explore perspectives on how genetic risk for prostate cancer is explained and understood through in-depth interviews with members of underserved communities. Findings from this work, alongside earlier results, will be used to co-design clear and accessible digital educational resources in collaboration with community members and relevant charities.
Participation in cancer screening programmes in the UK varies, with differences linked to socioeconomic status, ethnicity and health literacy. Similar inequalities are seen in access to prostate cancer genetics services, indicating a need for improved engagement.
Successful integration of genetics into prostate cancer care requires clear and inclusive information about genetic testing processes, possible outcomes and interpretation of results. Currently, there are limited resources explaining genetic risk for prostate cancer in an accessible way.
Co-production with representatives from underserved communities will ensure that educational materials are understandable, relevant and acceptable to all.
Detailed description
There is variability in uptake of cancer screening programmes in the UK with participation affected by socioeconomic status, ethnicity \& health literacy. This lack of representation is also seen within the prostate cancer genetics service, suggesting that further work is required to promote engagement. The successful mainstream integration of genetics into prostate cancer management will require people to understand the process, potential outcomes and interpretation of results. In addition, the information provided should be inclusive.
The barriers and facilitators to accessing prostate cancer screening work commenced under a service evaluation (CCR SE1284). This project provided valuable data from underserved communities which we wish to build on. This study aims to further explore perspectives on genetic risk explanation and education in further depth using semi-structured interviews and to use these and earlier findings to co-design educational digital materials to raise awareness about prostate cancer and genetic risk measurement, in keeping with the wishes from the communities that have worked with us.
Development of educational multi-media materials:
Utilising the Medical Research Council's Complex Intervention Design Framework, we will co-design educational materials, using the data collected from community champions and relevant charities.
Evaluation of educational multi-media materials:
The co-designed education materials will undergo evaluation in a pilot phase and then again after dissemination. Methods of evaluation will be adopted to include acceptability, usability and integration into clinical practice.
There are few current resources explaining the genetic risk of prostate cancer and opportunities to participate in genetic risk studies. The study will work alongside representatives from underserved communities to ensure that educational materials developed are accessible and acceptable to all.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semi-structured interview participants | – | Other: Surveys, Other: Semi-structured interviews and focus groupsUp to 60 participants for semi-structured interviews, 20 from each of the following underserved groups in prostate cancer screening; Black African and Black Caribbean, transgender and non-binary with a prostate, reduced access to healthcare. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and people with prostates from the following three communities: * Black African and Black Caribbean * Transgender women and non-binary people with prostates * Reduced access to healthcare
Key inclusion criteria (5 listed)
- Men and people with prostates age 18 and above
- Those who belong to the three underserved groups; Black African and Black Caribbean Ancestry, transgender and non-binary people with a prostate and those with reduced access to healthcare
- We allow intersectionality within reason and will narratively describe any instances of these in the writeup of findings
- Those who are able to freely consent to inclusion
- Individuals with and without a lived experience of prostate cancer
Key exclusion criteria (2 listed)
- To avoid exhaustion, we will only allow participation in two interview or focus groups per individual for the entirety of the study
- Those without capacity to consent to interview (capacity is assumed unless there is good reason to believe otherwise)
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 |
|---|---|---|
| SurveysUp to 30 surveys with 10 of these individuals undergoing short interviews to assess the improvement of their understanding around prostate cancer | Other | Semi-structured interview participants |
| Semi-structured interviews and focus groupsUp to 60 total semi-structured interviews (up to 20 per underserved group) to assess barriers and facilitators to prostate cancer screening and how they would like information to improve their understanding to be presented. | Other | Semi-structured interview participants |
Primary outcome
Evaluation of educational materials, demonstrating that users have an increase in understanding or prostate cancer risk and symptoms as well as genetic risk.
Time frame: February 2026 to August 2026
Using surveys (before and after use of resources) and interviews to measure improvement in understanding in individuals without experience of prostate cancer.
Increased representation from underserved groups in the referrals to our genetic research studies.
Time frame: As soon as the educational materials are live, which we aim to be from June 2026, increase in referrals to our genetic research studies from under-represented groups will be measured. This will take place for 12 months.
Using demographic data from referrals via our website to our genetic research studies
Qualitative data such as hits to the webpage and scroll depth and how many have signed up to the genetic research studies via the website.
Time frame: These data will be collected from as soon as the webpage goes live for the subsequent 12 months.
This is a short term measure of how effective and engaging the resources are.
2 secondary outcomes
Improved representation of underrepresented groups in our genetic risk studies.
Time frame: Measurements of the demographics of our research participants takes place currently. Any signficant change in representation will be reported for a minimum 12 months after the webpage and resources go live.
Reduced barriers to prostate cancer screening and participation in genetic research faced by underrepresented communities
Time frame: The web page will go live in July 2026 and will be a long term resource (many years), regularly updated by our team. There will also be rounds of evaluation, using surveys and interviews, with subsequent adaption.
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 12 Feb 2026.
- Individual participant dataSharing planned: No. There will be no confidential data shared outside of the research team and the study participants are members of the public, not patients.
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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.
Elizabeth Bancroft contact
Ros Eeles study chair
Institute of Cancer Research, United Kingdom
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Royal Marsden NHS Foundation Trust.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Rose Hall, MMBS (0000000000000000, rose.hall@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of educational materials, demonstrating that users have an increase in understanding or prostate cancer risk and symptoms as well as genetic risk. (time frame: February 2026 to August 2026). The study lists 3 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 12 Feb 2026.