RecruitingNCT06636526

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

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

Sponsor

Institute of Cancer Research, United Kingdom

Enrollment

1,000 participants

Start Date

Jun 2, 2025

Study Type

OBSERVATIONAL

Conditions

Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 40 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether a blood test called PRODICT® can predict prostate cancer risk in men from different ethnic backgrounds. Researchers want to see if the test works equally well across Black African/Caribbean, White European, and South/East Asian men. **You may be eligible if...** - You were born male and have a prostate - You are between 40 and 55 years old - You are of Black African/Black African-Caribbean, White European, South Asian, or East Asian ancestry (with all 4 grandparents of the same ancestry) - You have no known psychological, social, or geographic barriers to participation **You may NOT be eligible if...** - You have previously been diagnosed with prostate cancer - You are of mixed ancestry - You have had a previous cancer diagnosis with life expectancy under 5 years - You have had a negative prostate biopsy within the past year - You have significant psychological conditions that may worsen with study participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICThe 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.

OTHERProstate 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.

PROCEDUREMRI 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.

PROCEDUREProstate 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).