Clinical trial NCT06636526: The i4i PRODICT™ Study: Evaluation of the i4i PRODICT™ Test in Different Ethnic Groups (The i4i PRODICT™ Study).
Official title: The i4i PRODICT™ Study: Evaluation of the i4i PRODICT™ Test in Different Ethnic Groups.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Prostate cancer screening
Polygenic risk score
PSA
Genetic Predisposition
Lead sponsor: Institute of Cancer Research, United Kingdom
Sponsor class: OTHER
Collaborators: name: Royal Marsden NHS Foundation Trust
name: Imperial College London
First posted: 2024-10-10
Enrollment: 1000
Sex: MALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with a prostate\* (\*defined as people born with male reproductive organs), 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.

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* People with a prostate\* (PwP). \*People with a prostate is defined as people born with male reproductive organs.
* 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.

Exclusion Criteria:

* 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.
* Any significant psychological conditions that may be worsened or exacerbated by participation in the study.

Primary outcomes:
measure: The number of participants stratified by each ethnic background recruited and risk stratified using the i4i PRODICT™ test.
timeFrame: 2 years
Secondary outcomes:
measure: Calculation of the incidence of prostate cancers in the study population.
timeFrame: 3 years
measure: Record of clinical features of cancers diagnosed using the NCCN prostate cancer classification system
timeFrame: 8 years
measure: Calculation of the proportion of individuals taking up the study stratified by ethnic group.
timeFrame: 1 year
measure: Calculation of the attrition rate stratified by ethnic group.
timeFrame: 3 years
measure: Number of participants who comply with all components of the study protocol stratified by ethnic group.
timeFrame: 3 years
measure: Identification of barriers to protocol implementation
timeFrame: 3 years
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust
state: Surrey
city: London
country: United Kingdom
facility: The Royal Marsden Hospital
city: Sutton
country: United Kingdom
facility: The Royal Marsden Hospital
Study officials:
affiliation: The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust
name: Rosalind A Eeles, FRCP; FRCR
role: PRINCIPAL_INVESTIGATOR
References: