Prostate CancerNCT06636526
The i4i PRODICT® Study: Evaluation of the i4i PRODICT® Test in Different Ethnic Groups (The i4i PRODICT® Study).
An observational study of Prostate Cancer, run by Institute of Cancer Research, United Kingdom at 3 sites in United Kingdom.
Trial summary
The i4i PRODICT® study has been developed to investigate the uptake and acceptability of the i4i PRODICT® test which combines both common and rare genetic changes (genetic variants) into one saliva-based DNA test to estimate a person's future risk of prostate cancer (PrCa) in people of varying ethnicities. Read more about this study
- Who is it for?
- Ages 40 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- The i4i PRODICT® test., Prostate cancer screening and MRI Scan
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 2 Jun 2025to 6 Jan 2033
- 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 40 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: People with a prostate* (*defined as people born male), aged 40 - 55 years old of either (i) Black African and Black African-Caribbean, (ii) South Asian or East Asian or (iii) White European ancestry willing to undergo the i4i PRODICT® test to identify those at higher genetic risk for prostate cancer targeted screening.
Who may be able to join
- People with a prostate* (PwP). *People with a prostate is defined as people born male.
- Aged 40 to 55 years.
- People of either (i) Black African/Black African-Caribbean; (ii) White European; or (iii) South Asian or East Asian ancestry. These are defined as individuals with 4 grandparents of the same ancestry.
- Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.
Who cannot join
- Previous diagnosis of prostate cancer.
- People of mixed ancestry
- Previous diagnosis of cancer with a life-expectancy of less than five years.
- Negative prostate biopsy within one year before recruitment.
- Any significant psychological conditions that may be worsened or exacerbated by participation in the study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom3 sites, 3 recruiting
- Recruiting
The Royal Marsden Hospital
London, SW3 6JJ
prostate.research@rmh.nhs.uk
- Recruiting
The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
Rosalind A Eeles, FRCP; FRCR, +44 208 722 4483, Ros.Eeles@icr.ac.uk
Elizabeth K Bancroft, PhD, +44 208 722 4483, elizabeth.bancroft@rmh.nhs.uk
- Recruiting
The Royal Marsden Hospital
Sutton, SM2 5PT
prostate.research@rmh.nhs.uk
About this study
Official title: The i4i PRODICT® Study: Evaluation of the i4i PRODICT® Test in Different Ethnic Groups.
The i4i PRODICT® study has been developed to investigate the uptake and acceptability of the i4i PRODICT® test which combines both common and rare genetic changes (genetic variants) into one saliva-based DNA test to estimate a person's future risk of prostate cancer (PrCa) in people of varying ethnicities.
Read the detailed description
The i4i PRODICT® study aims to recruit 1000 people with a prostate (PwP*) aged 40-55 years old, divided into three ethnic backgrounds: (i) Black African and Black African-Caribbean, (ii) South Asian or East Asian or (iii) White European ancestry. These ethnic backgrounds are defined as having all 4 grandparents of the same ancestry. *People with a prostate is defined as people born male. We believe this will provide us with data that are reproducible and implementable within the UK population as well as enrich recruitment from underserved non-White European communities in order to evaluate this approach within a future potential national screening programme.
Recruitment is taking place via collaborating General Practice (GP) surgeries. For recruitment via GP practices, potential participants will be contacted via a letter from their GP, including a Participant Information Sheet (PIS) and if interested in the study, they will be asked to complete a reply slip found at the back of the PIS and return it to the study team for further information. Potential participants will also be identified through advertisements in the press, use of social media (in collaboration with press offices of the ICR/RMH, the funders of the study), outreach work in communities, presentations, posters/leaflets and animation videos about the study that could be displayed in GP surgeries, hospitals, public spaces and other community organisations. Potential participants identified via these routes will be considered as direct expressions of interest. For recruitment via direct expression of interest, potential participants can contact the study team directly to express interest in taking part in this study and receive further information. All potential participants will be sent a consent form and an eligibility questionnaire for completion.
Consented eligible participants will then be sent a DNA collection saliva kit. DNA will be extracted from saliva and analysed using the i4i PRODICT® test. Those participants identified at higher genetic risk (corresponding to the top 20% of the White European cohort, top 50% of the Black African/ African-Caribbean cohort and top 10% of the Asian cohort or those identified as having a rare variant) will be invited for prostate cancer (PrCa) screening annually for 3 years at the Royal Marsden Hospital. PrCa screening will mirror the primary care pathway: those in the high-risk group will be offered a PSA test and managed according to age-appropriate PSA thresholds. Where indicated, onward referral for prostate MRI, and prostate biopsy will follow as per the National Institute for Health and Care Excellence (NICE) guidelines. For participants receiving a diagnosis of PrCa, they will be offered treatment at The Royal Marsden Hospital, or onward referral to their local cancer centre if preferred by the patient.
- Conditions
- Prostate Cancer
- Being tested
- The i4i PRODICT® test., Prostate cancer screening, MRI Scan, Prostate Biopsy
- Keywords
- Prostate Cancer, Prostate cancer screening, Polygenic risk score, PSA, Genetic Predisposition
- Medical subject headings
- Prostatic Neoplasms, Genetic Risk Score, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The i4i PRODICT® test.Genetic
The i4i PRODICT® test combining both common and rare genetic variants into one saliva-based DNA test to estimate a person's future risk of prostate cancer. This test will be offered to all participants in Part 1 of the study. Participants will be classified into high-risk or population risk based on the results of the i4i PRODICT® test. Those classified as high-risk due to either falling within the high polygenic risk score category, and/or having a rare variant in a gene in the test will be offered targeted prostate cancer screening.
Prostate cancer screeningOther
Prostate cancer screening in the form of PSA testing will be offered to all participants identified as high risk from the i4i PRODICT® test for three years in order to track development of cancer in the future.
MRI ScanProcedure or surgery
MRI scan will be offered to participants identified in the high-risk category of the i4i PRODICT® test depending on their PSA test results. Where PSA is above age-specific threshold (>2.5ug/L for people with prostates (PwPs) aged 40-50 years and >3.5ug/L for PwPs aged 50-55 years), those with raised PSA levels will be referred for multiparametric MRI at The Royal Marsden Hospital.
Prostate BiopsyProcedure or surgery
Transperineal prostate biopsy under local anaesthetic will be offered to to participants identified in the high-risk category of the i4i PRODICT® test depending on their MRI results. Where a lesion is visible on MRI (defined as a PIRAD score ≥3) onward referral will be made for a transperineal targeted prostate biopsy (or current gold standard NHS practice).
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | People with a prostate aged 40-55 years of either (i) Black African and Black African-Caribbean, (ii) South Asian or East Asian or (iii) White European ancestry to undergo genetic testing using the i4i PRODICT® test to identify those at higher genetic risk for prostate cancer targeted screening. Receives: Genetic: The i4i PRODICT® test. | |
| Part 2 | Those classified as high-risk due to either falling within the high polygenic risk score category, and/or having a rare variant in a gene in the i4i PRODICT® test will be offered a hospital clinic appointment at the Royal Marsden Hospital to discuss prostate cancer screening. Receives: Genetic: The i4i PRODICT® test.; Other: Prostate cancer screening; Procedure: MRI Scan; Procedure: Prostate Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants stratified by each ethnic background recruited and risk stratified using the i4i PRODICT® test.
Total recruitment target is 1000 participants, split between three ethnic groups: Black African/Caribbean, South Asian and White.
Measured: 2 years
Secondary outcomes (6)
Calculation of the incidence of prostate cancers in the study population.
Calculation of incidence, reported as number of cancers, and percentage incidence of the study population.
Measured: 3 years
Record of clinical features of cancers diagnosed using the NCCN prostate cancer classification system
To look at clinical features and features of aggressiveness of the cancers diagnosed in the study population for comparison with general population data reporting clinical features of cancers diagnosed through routine diagnostic pathways.
Measured: 8 years
Calculation of the proportion of individuals taking up the study stratified by ethnic group.
To look at whether there is equal recruitment across all target ethnic groups
Measured: 1 year
Calculation of the attrition rate stratified by ethnic group.
Understand whether there are differences in attrition in different groups
Measured: 3 years
Number of participants who comply with all components of the study protocol stratified by ethnic group.
To understand whether there are differences in protocol compliance in different groups
Measured: 3 years
Identification of barriers to protocol implementation
Using qualitative research methods barriers to the implementation of the protocol will be identified to inform implementation into routine healthcare
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start2 Jun 2025
- Primary completion1 Dec 2028 (estimated)
- Study completion6 Jan 2033 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 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, Imperial College London
- Responsible party
- Sponsor
- Investigators
- Rosalind A Eeles, FRCP; FRCR, Principal investigator, The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636526
- Sponsor's protocol ID
- CCR6045
- Status last verified
- Feb 2026
- First submitted
- 7 Oct 2024
- Last updated
- 4 Feb 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 study Steerning Committee.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The i4i PRODICT® Study: Evaluation of the i4i PRODICT® Test in Different Ethnic Groups.
- ClinicalTrials.gov ID
- NCT06636526
- Acronym / sponsor ID
- CCR6045
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Prostate cancer screening, Polygenic risk score, PSA, Genetic Predisposition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust, Imperial College London
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 6 Jan 2033 (estimated)
- First posted
- 10 Oct 2024 (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 i4i PRODICT® study has been developed to investigate the uptake and acceptability of the i4i PRODICT® test which combines both common and rare genetic changes (genetic variants) into one saliva-based DNA test to estimate a person's future risk of prostate cancer (PrCa) in people of varying ethnicities.
Detailed description
The i4i PRODICT® study aims to recruit 1000 people with a prostate (PwP*) aged 40-55 years old, divided into three ethnic backgrounds: (i) Black African and Black African-Caribbean, (ii) South Asian or East Asian or (iii) White European ancestry. These ethnic backgrounds are defined as having all 4 grandparents of the same ancestry. *People with a prostate is defined as people born male. We believe this will provide us with data that are reproducible and implementable within the UK population as well as enrich recruitment from underserved non-White European communities in order to evaluate this approach within a future potential national screening programme.
Recruitment is taking place via collaborating General Practice (GP) surgeries. For recruitment via GP practices, potential participants will be contacted via a letter from their GP, including a Participant Information Sheet (PIS) and if interested in the study, they will be asked to complete a reply slip found at the back of the PIS and return it to the study team for further information. Potential participants will also be identified through advertisements in the press, use of social media (in collaboration with press offices of the ICR/RMH, the funders of the study), outreach work in communities, presentations, posters/leaflets and animation videos about the study that could be displayed in GP surgeries, hospitals, public spaces and other community organisations. Potential participants identified via these routes will be considered as direct expressions of interest. For recruitment via direct expression of interest, potential participants can contact the study team directly to express interest in taking part in this study and receive further information. All potential participants will be sent a consent form and an eligibility questionnaire for completion.
Consented eligible participants will then be sent a DNA collection saliva kit. DNA will be extracted from saliva and analysed using the i4i PRODICT® test. Those participants identified at higher genetic risk (corresponding to the top 20% of the White European cohort, top 50% of the Black African/ African-Caribbean cohort and top 10% of the Asian cohort or those identified as having a rare variant) will be invited for prostate cancer (PrCa) screening annually for 3 years at the Royal Marsden Hospital. PrCa screening will mirror the primary care pathway: those in the high-risk group will be offered a PSA test and managed according to age-appropriate PSA thresholds. Where indicated, onward referral for prostate MRI, and prostate biopsy will follow as per the National Institute for Health and Care Excellence (NICE) guidelines. For participants receiving a diagnosis of PrCa, they will be offered treatment at The Royal Marsden Hospital, or onward referral to their local cancer centre if preferred by the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | – | Genetic: The i4i PRODICT® test.People with a prostate aged 40-55 years of either (i) Black African and Black African-Caribbean, (ii) South Asian or East Asian or (iii) White European ancestry to undergo genetic testing using the i4i PRODICT® test to identify those at higher genetic risk for prostate cancer targeted screening. |
| Part 2 | – | Genetic: The i4i PRODICT® test., Other: Prostate cancer screening, Procedure: MRI Scan, Procedure: Prostate BiopsyThose classified as high-risk due to either falling within the high polygenic risk score category, and/or having a rare variant in a gene in the i4i PRODICT® test will be offered a hospital clinic appointment at the Royal Marsden Hospital to discuss prostate cancer screening. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- People with a prostate* (*defined as people born male), aged 40 - 55 years old of either (i) Black African and Black African-Caribbean, (ii) South Asian or East Asian or (iii) White European ancestry willing to undergo the i4i PRODICT® test to identify those at higher genetic risk for prostate cancer targeted screening.
Key inclusion criteria (4 listed)
- People with a prostate* (PwP). *People with a prostate is defined as people born male.
- Aged 40 to 55 years.
- People of either (i) Black African/Black African-Caribbean; (ii) White European; or (iii) South Asian or East Asian ancestry. These are defined as individuals with 4 grandparents of the same ancestry.
- Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.
Key exclusion criteria (5 listed)
- Previous diagnosis of prostate cancer.
- People of mixed ancestry
- Previous diagnosis of cancer with a life-expectancy of less than five years.
- Negative prostate biopsy within one year before recruitment.
- Any significant psychological conditions that may be worsened or exacerbated by participation in the study.
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 |
|---|---|---|
| The i4i PRODICT® test.The i4i PRODICT® test combining both common and rare genetic variants into one saliva-based DNA test to estimate a person's future risk of prostate cancer. This test will be offered to all participants in Part 1 of the study. Participants will be classified into high-risk or population risk based on the results of the i4i PRODICT® test. Those classified as high-risk due to either falling within the high polygenic risk score category, and/or having a rare variant in a gene in the test will be offered targeted prostate cancer screening. | Genetic | Part 1, Part 2 |
| Prostate cancer screeningProstate cancer screening in the form of PSA testing will be offered to all participants identified as high risk from the i4i PRODICT® test for three years in order to track development of cancer in the future. | Other | Part 2 |
| MRI ScanMRI scan will be offered to participants identified in the high-risk category of the i4i PRODICT® test depending on their PSA test results. Where PSA is above age-specific threshold (>2.5ug/L for people with prostates (PwPs) aged 40-50 years and >3.5ug/L for PwPs aged 50-55 years), those with raised PSA levels will be referred for multiparametric MRI at The Royal Marsden Hospital. | Procedure or surgery | Part 2 |
| Prostate BiopsyTransperineal prostate biopsy under local anaesthetic will be offered to to participants identified in the high-risk category of the i4i PRODICT® test depending on their MRI results. Where a lesion is visible on MRI (defined as a PIRAD score ≥3) onward referral will be made for a transperineal targeted prostate biopsy (or current gold standard NHS practice). | Procedure or surgery | Part 2 |
Primary outcome
The number of participants stratified by each ethnic background recruited and risk stratified using the i4i PRODICT® test.
Time frame: 2 years
Total recruitment target is 1000 participants, split between three ethnic groups: Black African/Caribbean, South Asian and White.
6 secondary outcomes
Calculation of the incidence of prostate cancers in the study population.
Time frame: 3 years
Record of clinical features of cancers diagnosed using the NCCN prostate cancer classification system
Time frame: 8 years
Calculation of the proportion of individuals taking up the study stratified by ethnic group.
Time frame: 1 year
Calculation of the attrition rate stratified by ethnic group.
Time frame: 3 years
Number of participants who comply with all components of the study protocol stratified by ethnic group.
Time frame: 3 years
Identification of barriers to protocol implementation
Time frame: 3 years
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 4 Feb 2026.
- Individual participant dataSharing planned: Yes. Anonymised data can be applied for via the study Steerning 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.
Rosalind A Eeles, FRCP; FRCR principal investigator
The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust
3 sites 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 3 sites in United Kingdom.
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 4 inclusion and 5 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 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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 Eva McGrowder, PhD (+44 208 722 4483, Eva.McGrowder@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants stratified by each ethnic background recruited and risk stratified using the i4i PRODICT® test. (time frame: 2 years). 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 4 Feb 2026.