Institute of Cancer Research, United Kingdom
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.
Prostate Cancer
The i4i PRODICT™ test.
Prostate cancer screening
MRI Scan
Prostate Biopsy
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 with male reproductive organs. 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 will take place via collaborating General Practice (GP) surgeries. Participants will be contacted via a letter from their GP and if interested in the study, they will be asked to complete an eligibility questionnaire and sign a consent form. Eligible participants will 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 (approximately 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. 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 |
| Estimated Enrollment : | 1000 participants |
| Official Title : | The I4i PRODICT™ Study: Evaluation of the I4i PRODICT™ Test in Different Ethnic Groups. |
| Actual Study Start Date : | 2025-01-06 |
| Estimated Primary Completion Date : | 2028-12-01 |
| Estimated Study Completion Date : | 2033-01-06 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 40 Years to 55 Years |
| Sexes Eligible for Study: | MALE |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT