RecruitingOBSERVATIONAL

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

The i4i PRODICT® study is investigating a new saliva test that can estimate a man's future risk of prostate cancer. This test combines information from several genetic changes found in your saliva. Researchers want to see how well men from different ethnic groups (Black African/Caribbean, South/East Asian, and White European) accept and use this test. The goal is to gather information that could help develop a future national screening program for prostate cancer in the UK. If you are a man aged 40-55, born male, and fit certain ethnic background criteria, you might be able to take part. The study involves providing a saliva sample for analysis.

At a glance

Status

Recruiting

Sponsor

Institute of Cancer Research, United Kingdom

Enrolment target

1,000

Start

02 Jun 2025

Estimated completion

06 Jan 2033

Prostate Cancer

What is this study about?

This research study, called the i4i PRODICT® study, is looking into a new way to help predict a man's risk of developing prostate cancer. It uses a special saliva test called the i4i PRODICT® test. This test works by looking at your DNA (the genetic instructions inside your body) to find certain common and rare changes that might increase your chance of getting prostate cancer in the future. The study wants to understand how well men from different backgrounds accept and use this new test.

The main aim is to see if this test could be useful across all groups of people in the UK. Specifically, the study is inviting men aged 40 to 55 who are from Black African/Caribbean, South Asian/East Asian, or White European backgrounds. By including men from different backgrounds, the researchers hope to make sure the test is accurate and fair for everyone. This is an important step because early detection is key for managing prostate cancer.

Ultimately, the information gathered from this study could help decide if this type of test should be used more widely in the future, perhaps as part of a national screening program for prostate cancer. While the study itself doesn't involve immediate prostate cancer screening or treatment, it's about finding better ways to understand and predict risk.

Key takeaways

The study is about a new saliva test to predict future prostate cancer risk.
It aims to include men aged 40-55 from diverse ethnic backgrounds.
Participation involves providing a saliva sample from home.
Your contribution helps research into better prostate cancer screening for the future.
The test looks at DNA changes to estimate risk, not to diagnose cancer immediately.

Who may be eligible?

To join this study, you need to be a man, specifically someone born male, between 40 and 55 years old. You should also belong to one of these ethnic groups: Black African/Black African-Caribbean, White European, or South/East Asian. This means all four of your grandparents should be from one of these same backgrounds.

There are also some reasons why you might not be able to join. For example, if you have already been diagnosed with prostate cancer or another type of cancer that is expected to shorten your life significantly (less than five years). If you've had a prostate biopsy within the last year that found no cancer, you also wouldn't be able to take part.

The researchers also want to make sure that taking part in the study won't cause you any unnecessary stress or problems. So, if you have any serious mental health conditions or other personal situations that might make it hard to follow the study's plan, you might not be suitable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man (born male)?
Are you between 40 and 55 years old?
Do all four of your grandparents come from the same ethnic background (either Black African/Caribbean, South/East Asian, or White European)?
Have you never been diagnosed with prostate cancer?
Have you not had a prostate biopsy in the last year that showed no cancer?
Are you generally well and able to follow study instructions without significant distress?

Answer every question to see your result.

What does participation involve?

If you are interested in taking part, you might receive a letter from your GP or see advertisements for the study. If you contact the study team, you'll receive more information and a form to agree to take part (a consent form), as well as a questionnaire to check if you're suitable.

If you are eligible and agree to join, the main thing you will do is provide a saliva sample. A kit for collecting your saliva will be sent to you. You'll simply follow the instructions to collect your saliva and send it back. The DNA in your saliva will then be analysed using the i4i PRODICT® test. The study does not involve any hospital visits, new medications, or follow-up appointments related to your test results. Your participation mainly involves providing this saliva sample, and the study team will handle the rest. The total duration of your active involvement in the study will be very short, focused on providing that sample.

Potential risks and benefits

Taking part in this study may not directly benefit your health, as it's a research study looking at a new test. However, you would be helping researchers understand prostate cancer risk better, which could lead to improved screening methods for everyone in the future. The main 'risk' is the time and effort it takes to provide a saliva sample and fill in some forms. There are no physical risks involved with the saliva test itself. You are completely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust
Verified postcode
Sutton, United Kingdom· Recruiting
The Royal Marsden Hospital
Verified postcode
London, United Kingdom· Recruiting
The Royal Marsden Hospital
Verified postcode
Sutton, United Kingdom· Recruiting

Common questions

What is prostate cancer?

Prostate cancer is a disease where cells in the prostate gland grow out of control. The prostate is a small gland in men that helps make semen. It's one of the most common cancers in men in the UK.

What is the i4i PRODICT® test?

It's a new test that uses your saliva to look at your DNA. It identifies genetic changes that might increase your future risk of getting prostate cancer.

Do I need to visit a hospital or clinic?

No, you do not need to attend any appointments. The main part of your involvement is providing a saliva sample which will be sent to you by post.

Will I get my test results?

The study information does not mention that individual participants will receive their test results. The study is for research purposes to understand the test's potential.

What does 'ethnic background' mean in this study?

It means the study is looking for men whose four grandparents are all from the same ethnic group: either Black African/Caribbean, South/East Asian, or White European.

How to find out more

Eva McGrowder, PhD

eva.mcgrowder@icr.ac.uk +44 208 722 4483 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.