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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age40-55
SponsorInstitute of Cancer Research, United Kingdom

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • The i4i PRODICT® test.
  • Prostate cancer screening
  • MRI Scan
  • Prostate Biopsy

Treatment groups

1,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Institute of Cancer Research, United Kingdom

Lead sponsor

Royal Marsden NHS Foundation Trust

Collaborator

Imperial College London

Collaborator