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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-02

Study Completion Date

2033-01-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Informed Decision Making Intervention in Screening for Prostate Cancer of Predominantly African American Participants in a Community Outreach Program

NCT02419846

Prostate Carcinoma

TERMINATED NA

Study of Biomarkers in Blood & Tissue Samples From Patients With Colorectal Cancer or Polyps & Patients Without Polyps

NCT00898378

Colorectal Cancer Healthy, no Evidence of Disease Precancerous Condition

COMPLETED

iCCaRE Consortium Pilot Project 1: Feasibility of a Point of Prostate Cancer Diagnosis Intervention for Newly Diagnosed Black Men

NCT06535802

Prostate Carcinoma

RECRUITING

Observational Cross-reactivity Study for Colorectal Cancer Diagnosis

NCT06889844

Colorectal Cancer

RECRUITING

Point of Care, Real-Time Urine Metabolomics Test to Diagnose Colorectal Cancers and Polyps in Low-and Middle-Income Countries

NCT05679960

Colorectal Cancer Screening

SUSPENDED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

The i4i PRODICT™ test.

Intervention Type 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 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.

The i4i PRODICT™ test.

Intervention Type 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.

Prostate cancer screening

Intervention Type 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.

MRI Scan

Intervention Type 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.

Prostate Biopsy

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

The i4i PRODICT™ test.

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.

Intervention Type GENETIC

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.

Intervention Type OTHER

MRI Scan

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.

Intervention Type PROCEDURE

Prostate Biopsy

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).

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes