A study to find out if looking at gene changes would be useful in screening for prostate cancer (PROFILE)

This study is looking at the DNA of men with a family history of prostate cancer, and comparing what they find with results from prostate cancer screening tests.

Prostate cancer is now the most common cancer in men in the UK. Doctors are working to understand more about the causes of prostate cancer. Because prostate cancer can sometimes run in families, researchers believe that changes to genes may increase men’s risk.

This study will look for gene changes in the DNA of men with a family history of prostate cancer. Men taking part will have some prostate cancer screening tests, and possibly an MRI scan. They will give permission for researchers to study blood, tissue and urine samples. Researchers will build a picture (a ‘genetic profile’) of each man’s gene changes. And look for links between these and the test results.

The aim of this study is to see if it is useful to include genetic profiles in screening for prostate cancer.

Recruitment

Start 01/09/2009

End 31/12/2012

Phase

Pilot

Who can enter

You can enter this trial if you are a man with a family history of prostate cancer in one of the following situations

You have a father, brother or son who was diagnosed with prostate cancer under the age of 70
You have 2 relatives on the same side of the family diagnosed with prostate cancer, and at least one was under 70 years old when they were diagnosed
You have 3 relatives on the same side of the family diagnosed with prostate cancer at any age

AND you are

Well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Able to take full part in the study
Between 40 and 69 years old

You cannot enter this study if you

Have had prostate cancer
Have any other cancer that your specialist thinks may become much worse in the next 5 years
Have had a sample of prostate tissue taken in the last year, and this did not show any cancer (a negative biopsy)

Trial design

This pilot study will recruit 100 men. Once you have agreed to join the study, you will see the team and fill out a questionnaire. The questionnaire will ask about your medical history and family history of cancer. If you have had any prostate cancer screening tests, for example a PSA blood test, the team will ask to see these results.

You also give a blood and urine sample. It is important that you do not ride a bike or have sex for 24 hours before you give the blood sample because that may affect some protein and hormone levels.

The team will look at the samples to see if you have any gene changes known to increase risk of prostate cancer. They will measure levels of different proteins and hormones in the samples, to try and understand what role these have in prostate cancer development. They will see if they can link these results with any gene changes they find. Lastly, they will test for a protein called prostate specific antigen (PSA). They will look at your PSA with your other results to see how useful it is for showing whether you have prostate cancer.

The study team will take a sample of tissue from your prostate gland (a prostate needle biopsy) at your next appointment. The doctor will use an ultrasound scan of your back passage to guide the needle they use for this biopsy. You have a pain killing injection (local anaesthetic) before the biopsy. The whole procedure will last about 45 minutes.

When your results are back you will see the team again. If your results show that you have prostate cancer, a specialist will discuss your treatment options with you. They will also give you information about your genetic profile. If you have any gene changes that may be linked to prostate cancer, they will tell you about these. But as this profile is just a research test, the team will not yet fully understand what the results mean. So they would like to contact you yearly for the next 5 years. They will send you a questionnaire to check for any health changes and update you with anything new they have discovered about the gene test results.

Your gene results will not affect any insurance policy you may have. The researchers will not share these results with anyone outside the team unless you say they can.

The team may also ask if you would be willing to have an MRI scan of the prostate before your biopsy. They will look for links between MRI scan results and other study test findings. You do not have to have the MRI scan if you do not want to. You can still take part in the study.

Hospital visits

You will see the study team 3 or 4 times in 6 months. Each visit will take up to an hour.

If you agree to have the MRI scan, you will probably need to make an extra hospital visit for this.

Side effects

After your ultrasound scan and biopsy you may notice blood when you pass water, open your bowels or have sex. The bleeding from your back passage should settle in a couple of days. The blood in your urine and semen should clear up in a few weeks.

There is a small risk that you will have an infection after your biopsy. You will take antibiotics to help prevent this.

As you will be having tests that can pick up prostate cancer, it is possible the study team could find this, even if you haven’t had any symptoms. If this happens, you will be able to talk about your treatment options with a specialist.