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.
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 male. 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 is taking place via collaborating General Practice (GP) surgeries. For recruitment via GP practices, potential participants will be contacted via a letter from their GP, including a Participant Information Sheet (PIS) and if interested in the study, they will be asked to complete a reply slip found at the back of the PIS and return it to the study team for further information. Potential participants will also be identified through advertisements in the press, use of social media (in collaboration with press offices of the ICR/RMH, the funders of the study), outreach work in communities, presentations, posters/leaflets and animation videos about the study that could be displayed in GP surgeries, hospitals, public spaces and other community organisations. Potential participants identified via these routes will be considered as direct expressions of interest. For recruitment via direct expression of interest, potential participants can contact the study team directly to express interest in taking part in this study and receive further information. All potential participants will be sent a consent form and an eligibility questionnaire for completion. Consented eligible participants will then 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 or those identified as having a rare variant) will be invited for prostate cancer (PrCa) screening annually for 3 years at the Royal Marsden Hospital. 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 National Institute for Health and Care Excellence (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
Enrollment
1,000
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.
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.
The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
RECRUITINGThe Royal Marsden Hospital
London, United Kingdom
RECRUITINGThe Royal Marsden Hospital
Sutton, United Kingdom
RECRUITINGThe 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.
Time frame: 2 years
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.
Time frame: 3 years
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.
Time frame: 8 years
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
Time frame: 1 year
Calculation of the attrition rate stratified by ethnic group.
Understand whether there are differences in attrition in different groups
Time frame: 3 years
Number of participants who comply with all components of the study protocol stratified by ethnic group.
To understand whether there are differences in protocol compliance in different groups
Time frame: 3 years
Identification of barriers to protocol implementation
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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.
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).
Using qualitative research methods barriers to the implementation of the protocol will be identified to inform implementation into routine healthcare
Time frame: 3 years