A study of a genetic test to identify people who have an increased risk of developing prostate cancer (BARCODE 1 Study)

Cancer type:

Prostate cancer

Status:

Open

Phase:

Other
This study is for white Caucasian men aged 55 to 69 years old who:
  • haven’t had prostate cancer
  • haven’t had a sample of tissue taken (biopsy) from their prostate in the last year

More about this trial

Researchers know that certain gene Open a glossary item changes or faulty genes can increase your risk of developing prostate cancer. In previous studies, they built a picture (a genetic profile) of the gene changes that they think can increase your risk. 
 
In this study, they want to find out whether this genetic profile can be used to identify people who have an increased risk of developing prostate cancer. 
 
Everyone taking part in this study gives a saliva sample. The study team then looks at the gene changes and gives a score for each change. The scores are added up to give an overall risk of developing prostate cancer. This is called a genetic risk score. 
 
If you have a high genetic risk score, it doesn’t mean that you will definitely have prostate cancer. But because you have a higher risk than the general population, the study team asks you have some tests. The tests you may have include a prostate biopsy and MRI scan. 
 
The main aim of this study is to find out whether the genetic profile can help to tell who has an increased risk of developing prostate cancer. 

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 
 
Who can take part
You may be able to join this study if all of the following apply. You:
 
are a white Caucasian man 
are 55 to 69 years old 
are well enough to be up and about for at least half the day (performance status of 0, 1 or 2) 
 
Who can’t take part
You cannot join this study if any of these apply. You:
  • are Jewish, mixed race or from any other ethnic background that isn’t Caucasian    
  • have had a prostate biopsy in the last year 
  • have had prostate cancer 
  • have another type of cancer that can’t be cured and is expected to limit your life expectancy  
  • can’t have a biopsy for any reason, for example you have diabetes Open a glossary itemwhich is difficult to control, certain heart conditions or take medicines that can make you bleed such as warfarin
  • have a body mass index (BMI) Open a glossary item higher than 40, or higher than 35 if you also have other medical problems such as diabetes 
  • can’t have an MRI scan for any reason, for example you have a pacemaker Open a glossary item, metal clips or fear of being in small spaces (claustrophobia) 
Why is this study only recruiting Caucasian men?
The genetic profile used in this study was developed from studies looking at white Caucasian men. 
 
People of different ethnic backgrounds have differences in their genetic profile. So using this genetic profile in men who are not Caucasian, could give an inaccurate genetic score.
 

Trial design

Researchers hope that around 5000 people from the UK will agree to take part. 
 
Your GP practice may send you a letter asking you to join this study, along with a participant information sheet, a consent form and a questionnaire. If you would like to take part, you need to:
  • read the information sheet
  • sign the consent form
  • complete the questionnaire 
You then send the consent and questionnaire back to the study team using a freepost envelope. You can also contact the study team directly. 
 
The research team looks at the questionnaire and may call you if they have any questions. They then send you a kit in the post, for you to give a saliva sample. You send the sample back to the study team using the envelope provided. 
 
The study team looks at the sample and work out your genetic risk score. 
 
A low genetic risk score
The study team sends you a letter with your score and you stop this study. You can call them if you have any questions about your genetic score. 
 
You can talk to your GP if you are worried about developing prostate cancer. It’s important to remember that this study does not consider other prostate cancer risks factors such as having a family history of prostate cancer. 
 
A high genetic risk score
You receive a letter explaining these results. The study team asks you to see a doctor at the Royal Marsden Hospital in London and have some tests. The tests you might have include:
Your doctor will tell you what happens during a prostate biopsy. You have a biopsy with a local or general anaesthetic Open a glossary item.
 
If your test results are normal and do not show any cancer, you have regular PSA blood tests. You have them every year, for up to 10 years. You can have the blood tests at your local GP or at the Royal Marsden Hospital. 
 
If your tests show that you have prostate cancer, your doctor will explain the different treatment options and side effects of these treatments. 
 
Medical records
The study team will ask to look at your medical records for up to 5 years after you joined this study. They will contact your GP to find out more about you and your medical history. 
 
Only people involved in this research looks at your records. Your details will be kept confidential. 

Hospital visits

You don’t have any extra hospital appointments if you have a low genetic risk score.

You have between 4 and 5 appointments at the Royal Marsden Hospital in London if you have a high genetic risk score. 

Side effects

You may find out that you have a high risk of developing prostate cancer. This can be upsetting. You have a phone number to call if you want to speak with the study team about this. 
 
Some prostate cancers are slow growing and may never give any symptoms or health problems. If you have a high genetic risk score, you might have tests and treatment for a slow growing cancer that are unnecessary. 
 
If you have a high genetic risk score, you might have some side effects from having prostate cancer tests. Side effects include pain and bleeding from having a biopsy. 
 
We have more information about the possible side effects of having:
The study team will tell you about all the possible side effects before you join this study. 

Location

National

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Ros Eeles

Supported by

Institute of Cancer Research (ICR)
The Royal Marsden NHS Foundation Trust
European Research Council 

 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16062

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Keith took part in a trial looking into hormone therapy

A picture of Keith

"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”

Last reviewed:

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