A study to find out if looking at gene changes could be part of prostate cancer screening (PROFILE study)

Cancer type:

Prostate cancer

Status:

Open

Phase:

Other

This study is looking at the role of gene changes in screening for prostate cancer. It is for men aged 40 to 69 who are of Caucasian (European, North African or Middle Eastern) descent and who have a family history of prostate cancer.  Or men who are of black African or black Caribbean descent.

This study follows on from a pilot study that looked at whether this would be a useful area of research. You can read about the PROFILE pilot study.

More about this trial

A family history means that you have someone in your family who has cancer. We know that a family history of prostate cancer, particularly if your relatives are diagnosed with the cancer before the age of 70, increases your risk. We also know that men of black African and black Caribbean descent have an increased risk of developing prostate cancer. So this study is looking to see if men in these 2 groups who have certain gene Open a glossary item changes are more likely to develop prostate cancer.

Men taking part will have prostate cancer screening tests. They may also have scans, some prostate tissue samples taken (a biopsy) as well as blood and urine tests. From the results of these tests researchers will build a picture (a genetic profile) of each man’s gene changes and also look for other biomarkers Open a glossary item for prostate cancer.

The researchers want to find out if knowing more about genetic changes can improve prostate cancer screening for men with an increased risk of getting the disease.

Who can enter

You can enter this trial if you are a man of Caucasian descent (people of European, North African or Middle Eastern descent) 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

Or you are of black African or black Caribbean descent and

  • Both your parents and all 4 grandparents are of the same origin

All men taking part need to be

  • 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
  • Aged 40 to 69 

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 (a prostate biopsy)
  • Are not able to have a prostate biopsy, for example you are taking a blood thinning medication such as warfarin or clopidogrel as this makes it more risky to have a biopsy
  • Have diabetes that isn't well controlled or a disease that affects the heart or blood vessels (cardivascular disease Open a glossary item) as this makes it more risky to have a biopsy
  • Have a body mass index (BMI) Open a glossary item that is 40 or above
  • Have a body mass index that is 35 or above and you also have other health conditions that mean you can't take part in the study (your doctor can tell you more about this)
  • Are unable to have an MRI scan for any reason such as having a pacemaker or any metal clips in your body
  • Are not of Caucasian or Afro-Caribbean descent

Trial design

This study needs 700 men to take part. It is taking place at the Royal Marsden Hospital in London.

Once you have agreed to join the study, you will see the study team and fill out a questionnaire, which asks about your medical history and family history of cancer. You will also answer questions about any prostate cancer screening tests you have had, for example a PSA blood test. Then you

  • Have a blood test
  • Give 2 urine samples
  • Have a prostate examination. The doctor puts a gloved finger into your back passage (rectum) to feel your prostate gland
  • Have the distance between your anus and your testicles measured. This is because researchers think the distance could be linked with prostate cancer

All men in the study will be offered a biopsy (some tissue taken) of their prostate gland. You do not have to have this done if you don’t want to. You can still take part in the study.

Before having a biopsy you will be asked if you would be willing to have an MRI scan and you may be asked if you would have an ultrasound scan too. These would be done on another day before your biopsy.

The scans help the doctor to see where it is best to do the biopsy. But they are for research purposes only. If you don’t want to have these scans you don’t have to, you can still take part in the study.

If you have a prostate biopsy, 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 will 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.

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 and also an ultrasound scan you need to make an extra hospital visit for this.

Side effects

If you have the 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 with a specialist about how big (the stage) the cancer is, what this means for you and whether you need any treatment.

Location

London
Sutton

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

Prof Rosalind Eeles

Supported by

Cancer Research UK
Biomedical Research Council (BMC)
Institute of Cancer Research (ICR)
Movember Foundation
National Institute for Health Research (NIHR)
Prof Eeles Research Fund
Ronald and Rita McAulay Fund

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11931

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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