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

NCT06636526 | Recruiting DMC

• 1 other identifier: CCR6045
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Prostate cancer screening; Polygenic risk score; PSA; Genetic Predisposition

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (6)

• Calculation of the incidence of prostate cancers in the study population.

  3 years

• Record of clinical features of cancers diagnosed using the NCCN prostate cancer classification system

  8 years

• Calculation of the proportion of individuals taking up the study stratified by ethnic group.

  1 year

• Calculation of the attrition rate stratified by ethnic group.

  3 years

• Number of participants who comply with all components of the study protocol stratified by ethnic group.

  3 years

Study Arms (2)

Part 1

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.

Genetic: The i4i PRODICT® test.

Part 2

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.

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

Interventions

MRI Scan PROCEDURE

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.

Part 2

Prostate Biopsy PROCEDURE

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).

Part 2

The i4i PRODICT® test. GENETIC

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.

Part 1; Part 2

Prostate cancer screening OTHER

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.

Part 2

Eligibility Criteria

• Age: 40 Years - 55 Years
• Gender Eligibility Details: The i4i PRODICT® study will be open to people with a prostate\* (PwP). \*People with a prostate is defined as people born male.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead
• Royal Marsden NHS Foundation Trust: collaborator
• Imperial College London: collaborator

Study Sites (3)

The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

The Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

RECRUITING

The Royal Marsden Hospital

Sutton, SM2 5PT, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Saliva, blood \& urine.

MeSH Terms

Conditions

Prostatic Neoplasms; Genetic Risk Score; Genetic Predisposition to Disease

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Rosalind A Eeles, FRCP; FRCR

  The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva McGrowder, PhD

CONTACT

+44 208 722 4483; Eva.McGrowder@icr.ac.uk

Elizabeth K Bancroft, PhD

CONTACT

+44 208 722 4483; elizabeth.bancroft@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 10, 2024
• Study Start: June 2, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): January 6, 2033
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within 18 months of the study opening the study protocol will be published
• Access Criteria: Study protocol will be published in a peer review journal. For access to other study documents an application can be made to the Steering Committee

Locations

GB (3)