The i4i PRODICT™ Study
Research type
Research Study
Full title
The i4i PRODICT™ Study: Evaluation of the i4i PRODICT™ test in different ethnic groups.
IRAS ID
338147
Contact name
Rosalind Eeles
Contact email
Sponsor organisation
The Institute of Cancer Research
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
60072, Central Portfolio Management System (CPMS)
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
This study has been developed to investigate the uptake and acceptability of the i4i PRODICT™ saliva test - combining both common and rare genetic variants into one saliva-based DNA test to estimate a person’s future risk of PrCa in people of varying ethnicities. Recruitment will be of PwPs aged 40-55 years will be via collaborating General Practice (GP) surgeries. The study aims to recruit 1000 individuals, divided into three ethnic backgrounds: (i) Black African or Black African-Caribbean, (ii) South Asian or East Asian or (iii) White-European ancestry. We believe this will provide us with data that are reproducible & 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.
Eligible participants will be sent a DNA collection saliva kit. DNA will be extracted from saliva & 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 & top 10% of the Asian cohort (~250 individuals in total) or those identified as having a rare variant (estimated to be 1 in 20 people – i.e. 50 individuals) will be invited for PrCa screening annually for 3 years. 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 NICE guidelines.
Genetic testing is currently only accessible via specialist genetics clinics for very high-risk families through rare variant testing, but our patient representatives believe that enabling access through primary-care and including all variants that increase risk, will be transformative, reducing health inequalities by democratising a potentially lifesaving tool.
REC name
London - Fulham Research Ethics Committee
REC reference
24/LO/0832
Date of REC Opinion
13 Jan 2025
REC opinion
Further Information Favourable Opinion