A study looking at screening for men who are at an increased risk of developing prostate cancer (IMPACT)

This study is trying to find out more about screening men who have an increased risk of prostate cancer because they have a faulty gene.

Research has shown that men who have inherited an alteration in the genes called BRCA1 and BRCA2 have an increased risk of developing prostate cancer. An alteration is also sometimes called a mutation or gene fault.

This trial will look at the PSA test and prostate biopsy to find out if they are a good way of picking up prostate cancer early in men who have this increased risk. The men taking part will also have other blood tests and urine tests. The results will hopefully help the researchers to

Develop a prostate cancer screening programme for men who have the faulty BRCA1 and BRCA2 genes (and to improve the tests that may be used for screening)
Improve the understanding of inherited faulty genes in prostate cancer

This trial is also known as the IMPACT study. This stands for Identification of Men with a genetic predisposition to Prost Ate Cancer; Targeted Screening in BRCA1/2 mutation carriers and controls.

Recruitment

Start 18/09/2005

End 31/12/2012

Phase

Other

Who can enter

You can enter this trial if you

Have been tested and found to have an alteration in the BRCA1 or BRCA2 gene OR
Have a relative, or relatives, that have an alteration in the BRCA1 or BRCA2 gene and you have also been tested, but the result was negative
Are aged 40 to 69 years
Are well enough to take part in this trial (performance status 0 to 2)

You cannot enter this trial if you

Have prostate cancer or have had prostate cancer in the past
Have any other type of advanced cancer that you will not recover from
Have had a prostate biopsy as a result of a raised PSA test result.

Trial design

This international trial is recruiting about 850 men who have an alteration in the BRCA1 or 2 gene. It is also recruiting 850 men who have been tested for these gene alterations, but have had a negative test result. This second group of men will be the control group. The research team will compare the results of the two groups.

You may be invited to take part in this trial by a doctor at your genetics clinic. If you have been tested for these genes and you are interested in taking part, discuss this with a doctor at your genetics clinic. If appropriate, they can refer you to one of the recruiting hospitals (see location and contact details).

If you take part, you will fill in a questionnaire about your health at the start of the trial. This will ask about any symptoms you may have, such as difficulty passing urine and details of any medical tests you have had in the last few months. You will also be asked about your family history of cancer.

You may be asked to complete another optional questionnaire asking whether taking part in the IMPACT study has changed how you feel about your general health and your risk of cancer.

You will have a blood and a urine test once a year for at least 5 years. Some of the blood will be used to measure your PSA level. The trial doctor will discuss the pros and cons of the PSA test with you before you have it. Depending on the test result, your doctor may recommend that you have a prostate biopsy.

During a prostate biopsy, the doctor will remove about 10 samples of your prostate gland. These will be checked for cancer. The trial doctors will ask if they can take 2 extra biopsies, which will be used for the purposes of research.

If your biopsy results do not show cancer, you will have a PSA test one year later as planned.

If you are diagnosed with prostate cancer as a result of a biopsy, the doctor will discuss treatment options with you.

Your blood and urine will be studied in the laboratory. The researchers will be looking at proteins, hormones and metabolic compounds (substances that the body makes). This will help them to understand the effects of the altered BRCA 1 and 2 genes on the way the body works.

Some of the blood will also be used to look for other genetic faults. If any results are found that are important for you and your family, you will be told about this (if this is what you have agreed to before hand).

After 5 years screening, you will be offered the option of having a biopsy, if you have not already had one during the trial.

Then you will carry on having screening every year until all the men joining this trial have had 5 years of screening.

This will also apply to the men who have been diagnosed with prostate cancer so that information is collected about their treatment.

There is more information on the IMPACT study website.

Hospital visits

If you already have regular appointments at your genetics clinic, your appointments as part of this trial can be arranged for the same time. If not, appointments can be arranged at a time convenient to you. The trial doctors may be able to visit you at home if this is easier for you.

Side effects

You may have bleeding and bruising around where you have your blood test.

Some men describe a prostate biopsy as being uncomfortable, other men say it is painful. There is a risk that you may develop an infection as a result of this test. You will have antibiotics before and after the biopsy to try to prevent this from happening. About one third of men have some bleeding following a biopsy. For example, bleeding when passing urine, opening your bowels or after sex. You may also have difficult passing urine initially.

You may feel quite anxious while waiting for the results of your PSA level or your biopsy. You may be diagnosed with prostate cancer as a result of taking part in this trial, so this can be a worrying time as you discuss treatment options with your doctor. The trial doctors are aware of this and you will have the contact details for a research nurse who will be able to support you.