Active not recruitingOBSERVATIONAL

The BARCODE 1 Study (Full Study): The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening.

The BARCODE 1 study aims to find a smarter way to check for prostate cancer by using information from your genes. Researchers are looking at specific genetic markers that are linked to a higher chance of developing prostate cancer. The idea is that instead of everyone getting screened, only men with a higher genetic risk would be offered further checks, like an MRI scan and a prostate biopsy. This could help find prostate cancer earlier in those most likely to get it, while avoiding unnecessary tests for others. The study started with a small group and is now expanding to include a total of 5,000 men aged 55 to 69 years.

At a glance

Status

Active not recruiting

Sponsor

Institute of Cancer Research, United Kingdom

Enrolment target

4,700

Start

14 Mar 2019

Estimated completion

31 Dec 2028

Prostate Cancer

What is this study about?

The BARCODE 1 study is exploring a new way to screen for prostate cancer. Currently, checking for prostate cancer can involve blood tests and sometimes biopsies, which aren't always needed for everyone and can cause worry. This study wants to see if we can use a simple genetic test from your saliva to work out who would benefit most from further prostate cancer checks.

Imagine your genes like a unique instruction book for your body. Scientists have found certain 'typos' or changes in this book that might make someone more likely to develop prostate cancer. This study looks at about 170 of these specific genetic changes. If your genetic profile shows you have a higher risk, similar to the top 10% of men in the population, you would then be invited for more detailed checks. These checks would include an MRI scan, which uses magnets and radio waves to create detailed pictures inside your body, and a prostate biopsy, where tiny tissue samples are taken with a needle for closer examination.

By focusing on men with a higher genetic risk, the study hopes to find prostate cancer earlier in those most at risk, while also reducing the number of men who undergo unnecessary tests. It's about making screening more targeted and effective.

Key takeaways

The study explores if genetic tests can make prostate cancer screening more focused.
A saliva sample is used for genetic profiling to assess your inherited risk.
Men with a top 10% genetic risk may be offered an MRI and biopsy.
It aims to find prostate cancer earlier in those most likely to develop it.
Participation involves genetic testing, and for some, further scans and biopsies.
You can withdraw from the study at any time.

Who may be eligible?

This study is particularly looking for men aged between 55 and 69 years old who are of Caucasian (white) background. You need to be generally well and able to follow the study instructions without difficulties due to personal circumstances.

There are some reasons why you wouldn't be able to join. For example, if you've been diagnosed with cancer before and have a life expectancy of less than five years, or if you've had a prostate biopsy recently that showed no cancer. If you've already been diagnosed with prostate cancer, you wouldn't be eligible.

Certain health conditions or medications might also prevent you from joining, especially if they make a prostate biopsy risky, such as taking blood-thinning medicines. You also can't have certain medical devices like pacemakers if you're not able to have an MRI scan, or health conditions that make an MRI scan unsafe, or a very high Body Mass Index (BMI). Significant psychological conditions that could be made worse by taking part would also exclude you.

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 between 55 and 69 years old?
Are you of Caucasian (white) ethnicity?
Are you generally well and able to attend appointments without difficulty?
Have you *not* had prostate cancer before?
Do you *not* have any severe health conditions or take blood-thinning medication that would make a biopsy risky?
Can you safely have an MRI scan (e.g., no pacemaker or severe claustrophobia)?

Answer every question to see your result.

What does participation involve?

If you are interested in taking part, your GP might send you an invitation letter. If you decide to go ahead, you'll need to sign a consent form and fill out a questionnaire to check you're suitable. If you qualify, you'll receive a kit to collect a saliva sample at home; this is how your DNA will be collected for genetic testing. If your genetic test shows you are in the top 10% of men with a higher prostate cancer risk, you will be invited for further tests. These will include an MRI scan and a prostate biopsy, which will be done under a local anaesthetic to numb the area. The study will also collect further biological samples. The results of your tests will be looked at alongside your genetic information. The total duration of participation for those who have a biopsy will involve several appointments and follow-ups related to the results.

Potential risks and benefits

Taking part in this study could potentially help identify prostate cancer earlier if you are in a higher-risk group due to your genes. This new approach might lead to more targeted and effective screening methods in the future. However, there are potential risks, especially if you proceed to an MRI and biopsy. An MRI can cause claustrophobia for some, and a biopsy, although done under local anaesthetic, carries a small risk of discomfort, bruising, bleeding, or infection. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

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

Institute of Cancer Research and Royal Marsden Hospital
Verified postcode
Sutton, United Kingdom

Common questions

What is genetic profiling?

Genetic profiling means looking at specific parts of your DNA (your body's instruction book) to see if you have certain genetic markers linked to a higher risk of prostate cancer.

How is a DNA sample collected?

Your DNA will be collected using a simple saliva kit that you can use at home, so no needles are involved for this part.

What happens if my genetic risk is high?

If your genetic risk is high, you will be invited for further checks, including an MRI scan and a prostate biopsy, to look more closely for prostate cancer.

Is the biopsy painful?

The prostate biopsy is done using a local anaesthetic, which numbs the area, so you shouldn't feel pain during the procedure, although you might feel some pressure or discomfort afterwards.

Will my GP know if I participate?

Yes, your GP identifies potential participants and is involved in the initial contact, so they would be aware if you decide to take part.