The i4i PRODICT® Study: Evaluation of the i4i PRODICT® Test in Different Ethnic Groups (The i4i PRODICT® Study).

February 2, 2026 updated by: Institute of Cancer Research, United Kingdom

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rosalind A Eeles, FRCP; FRCR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Genetic: 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.
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.
Genetic: 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.
Other: Prostate cancer screening
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.
Procedure: MRI Scan
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.
Procedure: Prostate Biopsy
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calculation of the incidence of prostate cancers in the study population.
Time Frame: 3 years
Calculation of incidence, reported as number of cancers, and percentage incidence of the study population.
3 years
Record of clinical features of cancers diagnosed using the NCCN prostate cancer classification system
Time Frame: 8 years
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.
8 years
Calculation of the proportion of individuals taking up the study stratified by ethnic group.
Time Frame: 1 year
To look at whether there is equal recruitment across all target ethnic groups
1 year
Calculation of the attrition rate stratified by ethnic group.
Time Frame: 3 years
Understand whether there are differences in attrition in different groups
3 years
Number of participants who comply with all components of the study protocol stratified by ethnic group.
Time Frame: 3 years
To understand whether there are differences in protocol compliance in different groups
3 years
Identification of barriers to protocol implementation
Time Frame: 3 years
Using qualitative research methods barriers to the implementation of the protocol will be identified to inform implementation into routine healthcare
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cancer Research, United Kingdom

Collaborators

Royal Marsden NHS Foundation Trust
Imperial College London

Investigators

  • Principal Investigator: Rosalind A Eeles, FRCP; FRCR, The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

January 6, 2033

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR6045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymised data can be applied for via the study Steerning Committee.

IPD Sharing Time Frame

Within 18 months of the study opening the study protocol will be published

IPD Sharing Access Criteria

Study protocol will be published in a peer review journal. For access to other study documents an application can be made to the Steering Committee

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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