The i4i PRODICT® Study: Evaluation of the i4i PRODICT® Test in Different Ethnic Groups (The i4i PRODICT® Study).
Recruiting · NCT06636526 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
MRI ScanProstate BiopsyProstate cancer screeningThe i4i PRODICT® test.
What this trial is 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.
Who can take part
Age range
40 Years to 55 Years
Sex
Male
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
3 locations listed.
- The Royal Marsden Hospital - London, United Kingdom
- The Royal Marsden Hospital - Sutton, United Kingdom
- The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust - Sutton, Surrey, United Kingdom