The i4i PRODICT® Study: Evaluation of the i4i PRODICT® Test in Different Ethnic Groups (The i4i PRODICT® Study).

Institute of Cancer Research, United Kingdom

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Genetic: The i4i PRODICT® test.; Procedure: Prostate Biopsy; Other: Prostate cancer screening; Procedure: MRI Scan

Study type: Observational

Funder types: Other

Identifiers

NCT06636526

CCR6045

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 1,000 estimated patients

Sex: Male

Ages: 40 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

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.

Trial design

1,000 participants in 2 patient groups

Part 1

Description:

People with a prostate aged 40-55 years of either (i) Black African and Black African-Caribbean, (ii) South Asian or East Asian or (iii) White European ancestry to undergo genetic testing using the i4i PRODICT® test to identify those at higher genetic risk for prostate cancer targeted screening.

Treatment:

Genetic: The i4i PRODICT® test.

Part 2

Description:

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 i4i PRODICT® test will be offered a hospital clinic appointment at the Royal Marsden Hospital to discuss prostate cancer screening.

Treatment:

Procedure: MRI Scan

Other: Prostate cancer screening

Procedure: Prostate Biopsy

Genetic: The i4i PRODICT® test.