Active not recruitingOBSERVATIONAL

The BARCODE 1 Pilot Study

The BARCODE 1 pilot study is looking at a new way to screen for prostate cancer. Researchers want to see if checking a man's genes can help find those who are more likely to get the disease. The idea is that men with a higher genetic risk could then be offered specific screening tests. The study will first involve 300 men in the UK. Doctors will invite men aged 55 to 69 who meet certain health criteria. Participants will provide a saliva sample for genetic testing. If their genes show they are at an increased risk, they will be invited for further checks, including a prostate biopsy. The hope is to find a better way to target prostate cancer screening in the future.

At a glance

Status

Active not recruiting

Sponsor

Institute of Cancer Research, United Kingdom

Enrolment target

329

Start

29 Apr 2016

Estimated completion

31 Dec 2028

Prostate Cancer

What is this study about?

The BARCODE 1 study is a research project exploring how we might improve the way we check for prostate cancer. Currently, screening methods aren't always perfect in identifying who truly needs further investigation. This study aims to find out if looking at someone's genes can help us work out their personal risk.

Researchers will use a special test to look at 170 specific genetic markers (known as SNPs, or 'snips') that have been linked to prostate cancer. The goal is to see if men with certain genetic patterns are more likely to develop prostate cancer. If this approach works, it could mean that in the future, men at a higher genetic risk could be offered targeted screening, while others might not need as many checks.

This first part of the study includes 300 men. The information gathered will help the researchers understand if this genetic testing method is a good way to identify men who would benefit most from specific prostate cancer screening. If successful, it could lead to much larger studies and potentially a new way to help prevent serious prostate cancer in the future.

Key takeaways

This study explores a new way to check prostate cancer risk using genes.
It aims to identify men who might benefit most from prostate cancer screening.
Participants will provide a saliva sample for genetic testing.
A small number of men might be invited for a biopsy based on their genetic risk.
The study helps researchers learn for future, larger studies.
Your normal medical care will not be affected if you take part or not.

Who may be eligible?

This study is looking for men aged between 55 and 69 years old. You need to be of Caucasian (white) background to take part. Researchers also need to make sure you are generally well enough, meaning you don't have severe health problems that would make it difficult or unsafe for you to participate fully.

You cannot take part if you are not of Caucasian background, including if you have a mixed racial background or are of Jewish descent. You also won't be able to join if you've been told you have cancer before (unless it's a very slow-growing type with a long life expectancy), or if you've had a prostate biopsy in the last year. If you've already been diagnosed with prostate cancer, you can't be in this study. Lastly, if you have other health issues like serious heart problems, poorly controlled diabetes, or if you take blood-thinning medicine like Warfarin or Clopidogrel, the risks of a biopsy might be too high for you to join.

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 aged between 55 and 69 years old?
Are you of Caucasian (white) ethnicity?
Are you generally well and fit enough for potential medical procedures?
Have you NOT been diagnosed with prostate cancer before?
Have you NOT had a prostate biopsy in the last year?
Do you NOT have serious health issues that would make a biopsy unsafe (e.g., severe heart conditions, certain blood thinners)?

Answer every question to see your result.

What does participation involve?

If you are invited and decide to take part, your first step will be to complete a questionnaire, either on paper or online, to make sure you meet the study requirements. If you're eligible, you will receive a free kit to collect a saliva sample at home. You'll just need to follow the instructions to provide some spit for genetic testing and send it back.

Most participants will complete these steps and their involvement will end there. However, if your genetic test results show you're in the top 10% for prostate cancer genetic risk (about 30 men out of the 300), you'll be invited for a further appointment. This will involve having a transrectal ultrasound (TRUS) guided prostate biopsy at a hospital, along with providing some additional biological samples. The study team will then look at your biopsy results alongside your genetic information and other health markers. The study does not involve taking any new medications, and for most, their involvement is minimal, while for the smaller group, it involves the procedures mentioned. The total duration for most participants is short, just completing the questionnaire and saliva sample. For those invited for a biopsy, it will involve additional appointments and follow-up related to the biopsy results.

Potential risks and benefits

Taking part in this study may offer the benefit of learning more about your personal genetic risk for prostate cancer, particularly if you are in the higher-risk group selected for a biopsy. This research could also help improve prostate cancer screening for everyone in the future. However, there are potential risks, especially for the smaller group invited for a biopsy, which carries common risks like pain, bruising, and a small chance of infection or bleeding. Please remember that participating is completely voluntary, and 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 closely at your DNA (your genetic code) to find small differences that might be linked to certain health conditions, like a higher risk of prostate cancer.

Why is this study only for men of Caucasian background?

The known genetic markers for prostate cancer can vary between different ethnic groups. To make sure the study results are clear and accurate, this initial pilot study is focusing on men of Caucasian background.

What is a prostate biopsy?

A prostate biopsy is a procedure where tiny tissue samples are taken from your prostate gland to check for cancer. It's usually done using a thin needle guided by ultrasound.

Will I find out my genetic risk result?

The study information indicates that if your genetic results show you are in the top 10% for risk, you will be invited for further tests, like a biopsy. More details on receiving individual genetic results should be discussed with the study team.

Do I have to pay to join the study?

No, all parts of the study, including the saliva kit and any tests, are provided for free if you are accepted into the study.