An observational study in Prostate Cancer, sponsored by Institute of Cancer Research, United Kingdom. Recruiting at 1 site in Netherlands. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Institute of Cancer Research, United Kingdom · Observational
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.
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 800 is above the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Institute of Cancer Research, United Kingdom is the lead sponsor of 113 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Be of either:
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Black men of African, and Caribbean ancestry as well as men of Mixed ethnicity.
Other: Patient Reported Outcome Measurements (PROMs)
Patient Reported Outcome Measurements collected via questionnaire
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 18 months
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.
Time frame: 18 months
Barriers and facilitators to successful ePROMs implementation
Identification of barriers and facilitators to successful ePROMs implementation.
Time frame: 18 months
Plan to share: Yes — Anonymised data can be applied for via the Data Access Committee.
Started Aug 2026 (actual). Primary completion is estimated for Dec 2027, 16 months after the start.
Of 541 non-industry observational studies under Prostatic Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 162. This study's planned 16 months is below that.
Counting every sponsor, half of 650 studies reached it within 60 months; a quarter within 29 and three quarters within 141.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 27, 2026: start May 2026 → Aug 2026, primary completion Mar 2027 → Dec 2027 and completion Mar 2027 → Dec 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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