i4i PRODICT® saliva genetic risk test for prostate cancer in diverse ethnic groups
The i4i PRODICT® Study: Evaluation of the i4i PRODICT® Test in Different Ethnic Groups.
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 40 Years to 55 Years |
| Sex | Male |
| Sponsor | Institute of Cancer Research, United Kingdom Academic / other |
| Locations | 3 sites (Sutton, Surrey and 2 other locations) |
| Trial ID | NCT06636526 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Sutton, Surrey and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.