"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”
A study looking at screening for men who are at an increased risk of developing prostate cancer (IMPACT)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
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.
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 men at higher genetic risk and controls.
More about this trial
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. Research has also indicated that there may be an increased risk of prostate cancer in men who inherit an alteration in a set of genes known as the mismatch repair genes (MSH2, MSH6 and MLH1). 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 are at an increased genetic risk of prostate cancer (and to improve the tests that may be used for screening)
- Improve the understanding of inherited faulty genes in prostate cancer
Who can enter
You can enter this trial if you
- Have been tested and found to have an alteration in the MSH2, MSH6 or MLH1 genes, or have a relative (or relatives) who has an alteration in one of these genes and you have 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
This international trial was recruiting men who have an alteration in the BRCA1 or 2 gene, and 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. Please note - the trial has now finished recruiting into these groups.
The trial is still recruiting men who have mutations in MSH2, MSH6 and MLH1 respectively, as well as men who have tested negative for a mutation known to be present in the family for each gene group.
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.
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 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 beforehand).
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.
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. A member of the trial team may be able to visit you at home if this is easier for you.
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.
How to join a clinical trial
Professor R. Eeles
Cancer Research UK
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
The Ronald and Rita McAulay Foundation