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

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Prostate cancer

Status:

Closed

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 which is difficult to control, certain heart conditions or take medicines that can make you bleed such as warfarin
have a body mass index (BMI) 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 , 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.

There is another study looking at gene changes in men who are of black African or black Caribbean descent.

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:

a blood test to measure the level of a protein called prostate specific antigen (PSA)
urine sample
an MRI scan
a prostate biopsy

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: