Prostate CancerBALANCENCT07529418
The BALANCE Study: BlAck and Mixed Men's Lived Experience With Prostate cANCEr-Diversity in Prostate Cancer PROMS Study
An observational study of Prostate Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in Netherlands.
Trial summary
The BALANCE study is a prospective Patient Reported Outcomes Measures (PROMs) study developed to look at the quality of life (QoL) of patients diagnosed with prostate cancer (PCa) in communities underrepresented in research, especially Black men of African, and Caribbean ancestry as well as men of Mixed ethnicity. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Patient Reported Outcome Measurements (PROMs)
- How many people
- 800 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Aug 2026to 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
- No healthy volunteers
- Adult, Older adult
Study population: The study will recruit a minimum of 800 participants who are of either Black African, Caribbean or Mixed ancestry who will be asked to complete an electronic survey. Participants will be aged 18 years or over and have had a prostate cancer diagnosis.
Who may be able to join
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age ≥ 18 years;
- Be of either:
- Black African ancestry; OR
- Black African-Caribbean ancestry; OR
- Mixed Black ancestry.
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- Diagnosed with PCa;
- Assigned male at birth;
- Participants with access to digital devices (smartphones, tablets, computers) or able to complete hardcopy versions of the survey;
- Participants willing to participate and provide informed consent.
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Participants having no diagnosis of PCa;
- Participants unable to provide consent;
- Participants assigned female at birth.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
The Erasmus MC
Rotterdam, Arnhem, 3015 GD
Dr Lionne Venderbos, PhD, 0031 6 5000 1668, l.venderbos@erasmusmc.nl
About this study
Official title: BlAck and Mixed Men's Lived Experience With Prostate cANCEr - Diversity in Prostate Cancer PROMS Study
The BALANCE study is a prospective Patient Reported Outcomes Measures (PROMs) study developed to look at the quality of life (QoL) of patients diagnosed with prostate cancer (PCa) in communities underrepresented in research, especially Black men of African, and Caribbean ancestry as well as men of Mixed ethnicity. This study will also investigate various PCa treatment types and their mental health impact on patients. There is a lack of research on PROMs in diverse populations. Collecting PROMs specifically from Black men and individuals with prostates who are receiving/have received treatment for PCa is essential for understanding their unique post-treatment experiences. The insights are vital to addressing documented disparities, tailoring supportive care and ultimately providing equitable health outcomes.
Participants in this study will be asked to complete a questionnaire (either electronically or hardcopy) to share their insights following their PCa diagnosis.
Read the detailed description
The BALANCE study is a Patient Reported Outcomes Measures (PROMs) study developed to look at the quality of life (QoL) of patients diagnosed with prostate cancer (PCa) in communities underrepresented in research, especially Black men of African, and Caribbean ancestry as well as men of Mixed ethnicity. This study is a questionnaire based study collecting data through electronic surveys. The study will also investigate various PCa treatment types and their mental health impact on patients. There is a lack of research on PROMs in diverse populations. Collecting PROMs specifically from Black men and individuals with prostates who are receiving/have received treatment for PCa is essential for understanding their unique post-treatment experiences. The insights are vital to addressing documented disparities, tailoring supportive care and ultimately providing equitable health outcomes.
The study will recruit a minimum of 800 participants who will be asked to complete an electronic survey. Participants will be aged 18 years or over and have had a prostate cancer diagnosis. All participants will be asked to provide informed consent before proceeding with the survey. After consenting, participants will be able to access the electronic survey. Participants will have the opportunity to save their results and access the survey across multiple sessions if not able to complete in one sitting. However, they will be asked to complete the survey only once.
Potential participants will be identified through collaboration with cancer charities, support groups, hospitals, study advertisements in the press, use of social media (in collaboration with the European Association of Urology Patient Office, the funders of the study), outreach work in communities, presentations, cancer alliances, posters/leaflets and animation videos about the study that could be displayed in hospitals, public spaces and other community organisations. Participants will be able to either contact the study team, their associated cancer charity or support group to express interest in taking part in this study and receive further information.
- Conditions
- Prostate Cancer
- Being tested
- Patient Reported Outcome Measurements (PROMs)
- 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 Reported Outcome Measurements (PROMs)Other
Patient Reported Outcome Measurements collected via questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Black men and those of Mixed ethnicity. | Black men of African, and Caribbean ancestry as well as men of Mixed ethnicity. Receives: Other: Patient Reported Outcome Measurements (PROMs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of prostate cancer on quality of life
Impact of prostate cancer on quality of life measured through European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30): overall health score, overall Quality of Life (QoL) score.
Minimum score =1; Maximum = 7; a higher score = better outcome; a lower score = worse outcome.
Measured: 18 months
The physical impact of treatments on quality of life
Physical impact of treatments on quality of life measured through the Expanded Prostate cancer Index Composite 26 (EPIC-26): sexual function, urinary function; bowel function; hormonal related symptoms.
The EPIC-26 consists of multiple measurements where the lowest score indicates a better outcome while the highest score indicates a worst outcome.
Measured: 18 months
The impact of treatments in mental health outcomes
Impact of treatments in mental health outcomes measured through European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30): anxiety, depression, financial worries.
Minimum score =1; Maximum = 4; a lower score = better outcome; a higher score = worse outcome.
Measured: 18 months
The functional impact of treatments on quality of life
Functional impact of treatments on quality of life measured through European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30): energy levels, physical activity.
Minimum score =1; Maximum = 4; a lower score = better outcome; a higher score = worse outcome.
Measured: 18 months
Secondary outcomes (2)
Usability and acceptance of ePROMs
The ease of use and acceptability of the electronic questionnaire will be measured by comparing the number of men who complete it online with the number who choose a paper version. We will also assess the quality of the information collected by comparing the number of unanswered questions in each format.
Measured: 18 months
Barriers and facilitators to successful ePROMs implementation
Identification of barriers and facilitators to successful ePROMs implementation.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start21 Aug 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 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.
- More trials run by Institute of Cancer Research, United KingdomThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust, European Association of Urology
- Responsible party
- Principal investigator, Elizabeth Bancroft, Institute of Cancer Research, United Kingdom
- Investigators
- Eamonn Rogers, FRCS(Urol), Study director, The European Association of Urology Patient Office
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529418
- Sponsor's protocol ID
- MEC-2025-0751
- Acronym
- BALANCE
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data can be applied for via the Data Access Committee.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BlAck and Mixed Men's Lived Experience With Prostate cANCEr - Diversity in Prostate Cancer PROMS Study
- ClinicalTrials.gov ID
- NCT07529418
- Acronym / sponsor ID
- BALANCE / MEC-2025-0751
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust, European Association of Urology
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Apr 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.
The BALANCE study is a prospective Patient Reported Outcomes Measures (PROMs) study developed to look at the quality of life (QoL) of patients diagnosed with prostate cancer (PCa) in communities underrepresented in research, especially Black men of African, and Caribbean ancestry as well as men of Mixed ethnicity. This study will also investigate various PCa treatment types and their mental health impact on patients. There is a lack of research on PROMs in diverse populations. Collecting PROMs specifically from Black men and individuals with prostates who are receiving/have received treatment for PCa is essential for understanding their unique post-treatment experiences. The insights are vital to addressing documented disparities, tailoring supportive care and ultimately providing equitable health outcomes.
Participants in this study will be asked to complete a questionnaire (either electronically or hardcopy) to share their insights following their PCa diagnosis.
Detailed description
The BALANCE study is a Patient Reported Outcomes Measures (PROMs) study developed to look at the quality of life (QoL) of patients diagnosed with prostate cancer (PCa) in communities underrepresented in research, especially Black men of African, and Caribbean ancestry as well as men of Mixed ethnicity. This study is a questionnaire based study collecting data through electronic surveys. The study will also investigate various PCa treatment types and their mental health impact on patients. There is a lack of research on PROMs in diverse populations. Collecting PROMs specifically from Black men and individuals with prostates who are receiving/have received treatment for PCa is essential for understanding their unique post-treatment experiences. The insights are vital to addressing documented disparities, tailoring supportive care and ultimately providing equitable health outcomes.
The study will recruit a minimum of 800 participants who will be asked to complete an electronic survey. Participants will be aged 18 years or over and have had a prostate cancer diagnosis. All participants will be asked to provide informed consent before proceeding with the survey. After consenting, participants will be able to access the electronic survey. Participants will have the opportunity to save their results and access the survey across multiple sessions if not able to complete in one sitting. However, they will be asked to complete the survey only once.
Potential participants will be identified through collaboration with cancer charities, support groups, hospitals, study advertisements in the press, use of social media (in collaboration with the European Association of Urology Patient Office, the funders of the study), outreach work in communities, presentations, cancer alliances, posters/leaflets and animation videos about the study that could be displayed in hospitals, public spaces and other community organisations. Participants will be able to either contact the study team, their associated cancer charity or support group to express interest in taking part in this study and receive further information.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Black men and those of Mixed ethnicity. | – | Other: Patient Reported Outcome Measurements (PROMs)Black men of African, and Caribbean ancestry as well as men of Mixed ethnicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will recruit a minimum of 800 participants who are of either Black African, Caribbean or Mixed ancestry who will be asked to complete an electronic survey. Participants will be aged 18 years or over and have had a prostate cancer diagnosis.
Key inclusion criteria (10 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age ≥ 18 years;
- Be of either:
- Diagnosed with PCa;
- Assigned male at birth;
Key exclusion criteria (4 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Participants having no diagnosis of PCa;
- Participants unable to provide consent;
- Participants assigned female at birth.
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 |
|---|---|---|
| Patient Reported Outcome Measurements (PROMs)Patient Reported Outcome Measurements collected via questionnaire | Other | Black men and those of Mixed ethnicity. |
Primary outcome
The impact of prostate cancer on quality of life
Time frame: 18 months
Impact of prostate cancer on quality of life measured through European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30): overall health score, overall Quality of Life (QoL) score. Minimum score =1; Maximum = 7; a higher score = better outcome; a lower score = worse outcome.
The physical impact of treatments on quality of life
Time frame: 18 months
Physical impact of treatments on quality of life measured through the Expanded Prostate cancer Index Composite 26 (EPIC-26): sexual function, urinary function; bowel function; hormonal related symptoms. The EPIC-26 consists of multiple measurements where the lowest score indicates a better outcome while the highest score indicates a worst outcome.
The impact of treatments in mental health outcomes
Time frame: 18 months
Impact of treatments in mental health outcomes measured through European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30): anxiety, depression, financial worries. Minimum score =1; Maximum = 4; a lower score = better outcome; a higher score = worse outcome.
The functional impact of treatments on quality of life
Time frame: 18 months
Functional impact of treatments on quality of life measured through European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30): energy levels, physical activity. Minimum score =1; Maximum = 4; a lower score = better outcome; a higher score = worse outcome.
2 secondary outcomes
Usability and acceptance of ePROMs
Time frame: 18 months
Barriers and facilitators to successful ePROMs implementation
Time frame: 18 months
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 27 Oct 2026.
- BALANCE Study WebpageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymised data can be applied for via the Data Access Committee.
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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.
Eamonn Rogers, FRCS(Urol) study director
The European Association of Urology Patient Office
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 Prostate Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in Netherlands.
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 10 inclusion and 4 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 27 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 Netherlands. 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 Esther Robijn (+31 (0)26 389 0680, e.robijn@uroweb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impact of prostate cancer on quality of life (time frame: 18 months). The study lists 4 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 27 Oct 2026.