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

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

Interventions

GENETIC

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.

OTHER

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.

PROCEDURE

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.

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).

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• Institute of Cancer Research, United Kingdom

  lead OTHER

Principal Investigators

• Rosalind A Eeles, FRCP; FRCR · The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust

Eligibility

Min Age

40 Years

Max Age

55 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-06-02

Primary Completion

2028-12-01

Completion

2033-01-06

Countries

• United Kingdom

Study Locations