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Simple spit test could predict prostate cancer risk in black, asian, and white men

NCT ID NCT06636526

Diagnosis Sponsor: Institute of Cancer Research, United Kingdom Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new saliva-based DNA test called i4i PRODICT® that estimates a person's future risk of prostate cancer. Researchers want to see if men of Black African/Caribbean, South Asian, and White backgrounds aged 40-55 will take the test and find it acceptable. The test looks at both common and rare genetic changes to classify men as high-risk or population risk, and those at high risk will be offered targeted screening.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
i4i PRODICT® test (saliva-based DNA test for genetic risk of prostate cancer)
What this could lead to
If successful, this test could help identify men at high risk for prostate cancer earlier, especially in ethnic groups that are often understudied.
What could go wrong
This is an early study focused on feasibility and uptake, not on proving the test prevents or detects cancer. The test may not accurately predict risk in all groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jan 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

People with a prostate\* (\*defined as people born male), aged 40 - 55 years old of either (i) Black African and Black African-Caribbean, (ii) South Asian or East Asian or (iii) White European ancestry willing to undergo the i4i PRODICT® test to identify those at higher genetic risk for prostate cancer targeted screening.

Ages

40 to 55 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Genetic Risk Score inherited disease susceptibility prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust

    RECRUITING

    Sutton, Surrey, SM2 5PT, United Kingdom

  • The Royal Marsden Hospital

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • The Royal Marsden Hospital

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

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