Clinical trial · Observational
The i4i PRODICT® Study: Evaluation of the i4i PRODICT® Test in Different Ethnic Groups (The i4i PRODICT® Study).
The i4i PRODICT® Study: Evaluation of the i4i PRODICT® Test in Different Ethnic Groups.
NCT06636526CI-TRIAL-00102385recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI Scan | Procedure | — | UNRESOLVED |
| Prostate Biopsy | Procedure | — | UNRESOLVED |
| Prostate cancer screening | Other | — | UNRESOLVED |
| The i4i PRODICT® test. | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Part 1
- description
- 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.
- interventionNames
- Genetic: The i4i PRODICT® test.
- label
- Part 2
- description
- 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.
- interventionNames
- Genetic: The i4i PRODICT® test.
- Other: Prostate cancer screening
- Procedure: MRI Scan
- Procedure: Prostate Biopsy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.