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.
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.
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.
People with a prostate\* (\*defined as people born male), aged 40 - 55 years old of either (i) Black African and Black African-Caribbean, (ii) South Asian or East Asian or (iii) White European ancestry willing to undergo the i4i PRODICT® test to identify those at higher genetic risk for prostate cancer targeted screening.
Cohort
Prospective
The i4i PRODICT® test.
GeneticThe 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.
Prostate cancer screening
Other interventionProstate 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.
MRI Scan
Procedure/SurgeryMRI 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.
Prostate Biopsy
Procedure/SurgeryTransperineal 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).
The number of participants stratified by each ethnic background recruited and risk stratified using the i4i PRODICT® test.
Total recruitment target is 1000 participants, split between three ethnic groups: Black African/Caribbean, South Asian and White.
Calculation of the incidence of prostate cancers in the study population.
Calculation of incidence, reported as number of cancers, and percentage incidence of the study population.
Record of clinical features of cancers diagnosed using the NCCN prostate cancer classification system
To look at clinical features and features of aggressiveness of the cancers diagnosed in the study population for comparison with general population data reporting clinical features of cancers diagnosed through routine diagnostic pathways.
Calculation of the proportion of individuals taking up the study stratified by ethnic group.
To look at whether there is equal recruitment across all target ethnic groups
Calculation of the attrition rate stratified by ethnic group.
Understand whether there are differences in attrition in different groups
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Institute of Cancer Research, United Kingdom
Lead sponsor
Royal Marsden NHS Foundation Trust
Collaborator
Imperial College London
Collaborator
