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Clinical trial Recruiting at 3 sites Observational Ages 40 to 55 Men only

i4i PRODICT® saliva genetic risk test for prostate cancer in diverse ethnic groups

Official title: The i4i PRODICT® Study: Evaluation of the i4i PRODICT® Test in Different Ethnic Groups.

Run by Institute of Cancer Research, United Kingdom · NCT06636526 · Data updated 2026-11-12

This project will test a saliva-based genetic test (i4i PRODICT®) to estimate future prostate cancer risk in people with a prostate aged 40–55 from Black African/Black Caribbean, South Asian/East Asian, and White European backgrounds.

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Quick facts

Study typeObservational
Ages40 Years to 55 Years
SexMen only
Enrollment1000 (estimated)
SponsorInstitute of Cancer Research, United Kingdom
Academic / other
Locations3 sites (Sutton, Surrey and 2 other locations)
StatusRecruiting
StartedJune 2, 2025
Main results expectedDecember 1, 2028
Study endsJanuary 6, 2033
Registry record updatedFebruary 4, 2026
Trial IDNCT06636526 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are people with a prostate aged 40–55 without a prior prostate cancer diagnosis who have four grandparents of the same specified ancestry (Black African/Black Caribbean, South Asian/East Asian, or White European) and can comply with study procedures.

Probably not a fit

Those unlikely to benefit include people with a prior prostate cancer diagnosis, people of mixed ancestry (excluded), individuals outside the 40–55 age range, people with life-limiting cancer or severe psychological conditions, and those unable to attend participating UK sites.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study will recruit 1,000 people with a prostate aged 40–55 divided into three ancestry groups (Black African/Black African-Caribbean; South Asian or East Asian; White European) to examine uptake and acceptability of the i4i PRODICT® saliva DNA test combining common and rare genetic variants. Participants will be identified through collaborating GP practices, community outreach, and media, and will provide saliva for genetic analysis and may undergo standard screening procedures such as PSA, MRI, or biopsy as clinically indicated. The protocol requires ancestry defined by all four grandparents to reduce heterogeneity and to allow comparison of test performance and acceptability across groups. The observational design is intended to generate data to support implementation and future population screening plans in the UK, with attention to underrepresented non-White communities.

Why it matters

Potential benefit: If successful, the test could improve personalized prostate cancer risk prediction and help tailor earlier or more targeted screening for people at higher genetic risk, especially in underrepresented ethnic groups.

How similar studies have gone: Polygenic risk scores and saliva-based genetic tests have shown promise for predicting prostate cancer risk in mainly European-ancestry populations, but validation and demonstrated accuracy in non-White groups remain limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust
    Sutton, Surrey, United Kingdom     Recruiting
  • The Royal Marsden Hospital
    London, United Kingdom     Recruiting
  • The Royal Marsden Hospital
    Sutton, United Kingdom     Recruiting

Study contacts

  • Principal investigator: Rosalind A Eeles, FRCP; FRCR — The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust
  • Study coordinator: Eva McGrowder, PhD
  • Email: Eva.McGrowder@icr.ac.uk
  • Phone: +44 208 722 4483

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.