FAQs

Questions

Genetic Testing

Q1. When assessing whether or not a person has a strong family history of cancer, what is looked for by the genetics team?"

Q2. I have a strong family history of cancer and I wish to have a genetics consultation. How can I organise one?"

Q3. I have a strong family history of cancer and I wish to undergo genetic testing, but I have been told that genetic testing to find a family specific gene alteration (diagnostic testing) can only be carried out on an affected family member? Why?

Taking part in IMPACT

Q4. Will I be recompensed for any cost incurred whilst taking part in the IMPACT study?

Q5. Why do you need to take both blood and urine samples?

Q6. Why do I need to refrain from ejaculation for 24 hours before the blood sample is taken?

Q7. When will I get the results of my PSA test?

Q8. How often do I need to come to the hospital/gene clinic?

Q9. How long will the appointment take?

Eligibility Criteria

Q10.I fit your study’s eligibility criteria, and I am interested in taking part in IMPACT, but I am unsure whether or not the study is being run in my country. How can I find out?

Q11. I live in UK and I would like to know which centres are recruiting for IMPACT?

Q12. IMPACT is being run in my country, and I am both eligible for the study and interested in participating, but there are no collaborating research centres close to where I live. Can I still take part in the IMPACT study?

Q13. I have been told I am not eligible for the IMPACT study because of my age. Why is this?

Q14. I have been told I need to check my eligibility for the IMPACT study because of my previous history of raised PSA and/or prostate biopsy. Why is this?

Q15. There is a BRCA1 or BRCA2 gene alteration running within my family, but I am not a carrier. I have been informed that I am eligible for the IMPACT study. Why, when I am not at an increased risk of developing prostate cancer?

Q16. I carry a BRCA1 or BRCA2 variant of uncertain significance (VUS). Can I take part in the IMPACT study?

Q17. I have a strong family history of prostate cancer, but no genetic (BRCA1/2) alteration has been found. I would like to take part in IMPACT. Am I eligible for this study?

PSA Testing

Q18. What is the prostate specific antigen (PSA)?

Q19. What is the prostate specific antigen (PSA) test?

Q20. Why is there so much controversy over the use of the PSA test to screen for prostate cancer?

Q21. Are there any alternative methods available to screen for prostate cancer?

Q22. I am aware that in the UK the NHS suggests a threshold for biopsy of 4.0ng/ml, yet the IMPACT study is referring patients for biopsy if they have a PSA level of 3.0ng/ml. Why?

Q23. If my PSA level is above 3.0ng/ml does this mean I have prostate cancer?

Q24. If my PSA level is below 3.0ng/ml does this mean I do not have prostate cancer?

Prostate Biopsy

Q25. What happens during a prostate biopsy?

Q26. What is a biopsy core?

Q27. I have been identified as having PIN. What does this mean?

Q28. I have been told that ten cores will be taken when I undergo my prostate biopsy, and two extra for research purposes. Why are the extra two required?

Q29. I have a PSA level which is over 3.0ng/ml, but I had a normal prostate biopsy. Why am I not being referred for another biopsy, despite my high PSA level?

Q30. I have read that there is a chance that cancer cells can be missed during biopsy. Why does this happen?

Q31. If prostate cancer is diagnosed, what happens next?

Answers

A1. When assessing whether or not a person has a strong family history of cancer, what is looked for by the genetics team?

A doctor or genetic counsellor will look for particular patterns of cancer in the family. Please refer to the Genetics and Cancer section of this website for further information.

A2. I have a strong family history of cancer and I wish to have a genetics consultation. How can I organise one?

Different countries may have different processes. Please refer to the Genetics and Cancer: What can I do section of this website for further information.

A3. I have a strong family history of cancer and I wish to undergo genetic testing, but I have been told that genetic testing to find a family specific gene alteration (diagnostic testing) can only be carried out on an affected family member? Why?

For most families with a strong history of cancer, genetic testing will first be carried out on an individual within that family who is affected by cancer (a diagnostic genetic test). This is because the process of genetic analysis can be extremely complicated, and the interpretation of such an analysis can be very difficult (especially in an individual who is unaffected by cancer); also, not all individuals within a family will carry the harmful gene alteration (if there is such an alteration present within that family) but a person affected by cancer is more likely to be a carrier. By testing that person you are therefore more likely to successfully find the gene alteration causing cancer in that family. Please refer to the Genetic Testing section of this website for further information.

A4. Will I be recompensed for any cost incurred whilst taking part in the IMPACT study?

Yes, all travel expenses incurred as a result of taking part in this study will be reimbursed.

A5. Why do you need to take both blood and urine samples?

The blood test will be used to measure your prostate specific antigen (PSA) level, which is the only clinical test that is carried out. Blood is also taken for further research. We would like to look for better markers of prostate cancer and for other genes that may predispose to prostate cancer - this analysis is for research purposes only, and has no insurance implications. You will only be informed of results that are of clinical importance to you or your family if it has been agreed beforehand that you would like to know.

Blood and urine samples will also be analysed in the laboratory for proteins, hormones and metabolic compounds (substances the body makes), with the aim of better understanding how BRCA1 and BRCA2 alterations affect the workings of the body.

A6. Why do I need to refrain from ejaculation for 24 hours before the blood sample is taken?

Ejaculation can cause PSA levels to fluctuate. In order for us to assess your baseline PSA accurately it is important that you refrain from ejaculation for 24 hours before the sample is taken.

A7. When will I get the results of my PSA test?

This will differ between research centres.

A8. How often do I need to come to the hospital/gene clinic?

This answer refers to visits made to the clinic which are solely for the purpose of participating in the IMPACT Study.

The number of times that you need to visit the hospital/gene clinic will depend on the results of your blood PSA test and prostate biopsy.

  • If you have a blood PSA level which is lower than 3.0ng/ml then you will only need to visit the hospital/gene clinic once a year for your annual PSA.
  • If you have a blood PSA level of 3.0ng/ml or greater, you will be advised to undergo a prostate biopsy, and be referred to an Urologist (a specialist in diseases of the urinary organs and urinary tract) who will undertake the biopsy. The procedure will generally be undertaken at the out-patient’s clinic (an overnight stay is not necessary). A separate appointment to see the Urologist and talk through the procedure in detail is optional.
  • Another visit with the urologist/ geneticist /oncologist will be required to receive the results of your prostate biopsy.
  • The number of additional visits that you need to make depends on the results of your biopsy.

A9. How long will the appointment take?

It is important to allow at least 1 hour for your first appointment with the study team. The appointment length will vary from person to person, but you will be provided with as much time as is needed to answer your questions. Please note, by attending an appointment there is no obligation to take part in the study. You are also welcome to go away and think about taking part for as long as you need, or to attend for several appointments to discuss the pros and cons of taking part.

Subsequent appointments to undertake PSA testing will take approximately 30 minutes.

Should you be referred to a specialist for a prostate biopsy, it is expected that this procedure will take approximately 45 minutes, and appointments can be arranged to see the urologist before the biopsy to discuss the pros and cons of this procedure.

A10. I fit your study’s eligibility criteria, and I am interested in taking part in IMPACT, but I am unsure whether or not the study is being run in my country. How can I find out?

For a list of all countries and research centres who are confirmed collaborators in the IMPACT study, please refer to the local contact information section of our website.

Here you will also find a list of countries in which IMPACT is actively recruiting research centres. Please check this section frequently to receive up-to-date information about the latest research centres to join our study.

A11. I live in UK and I would like to know which centres are recruiting for IMPACT?

Please refer to the local contact information section of our website for a list of UK research centres which are recruiting IMPACT participants.

A12. IMPACT is being run in my country, and I am both eligible for the study and interested in participating, but there are no collaborating research centres close to where I live. Can I still take part in the IMPACT study?

Unfortunately, the answer to this question varies depending on your country of residence, because IMPACT is being funded by different research bodies in different countries. For example, in the UK funding has been provided, by research bodies and charities, to allow a participant (or their research team) to travel as far as is necessary within the UK, to enable participation in the study. This is not the case for every country. To find out whether of not you are able to participate in the IMPACT study, please contact the closest participating research centre within your country (please refer to the local contact information section for contact details) and ask them if it is possible to make arrangements for your participation.

A13. I have been toldd I am not eligible for the IMPACT study because of my age. Why is this?

IMPACT is a long-running research study which aims to assess

prostate cancer incidence
and development in carriers of BRCA1 and BRCA2

gene alterations. As we are looking at a group of men for whom evidence suggests that prostate cancer occurs earlier than in the general population, we are aiming to recruit men aged between 40 and 69 years of age. It is highly unusual for prostate cancer to develop in men before the age of 45.

A14. I have been told I need to check my eligibility for the IMPACT study because of my previous history of raised PSA and/or prostate biopsy. Why is this?

The study team may need to speak to your doctor or look at your medical records to assess whether you are eligible for the study. Please contact your local study team directly to talk through your medical history and talk about taking part in the study.

A15. There is a BRCA1 or BRCA2 gene alteration running within my family, but I am not a carrier. I have been informed that I am eligible for the IMPACT study. Why, when I am not at an increased risk of developing prostate cancer?

You have been invited to take part in the study as a member of the control group. It is essential that we include men who do not have an inherited cancer risk so that we can make comparisons with results from the BRCA1 and BRCA2 carrier groups.

A16. I carry a BRCA1 or BRCA2 variant of uncertain significance (VUS). Can I take part in the IMPACT study?

Unfortunately, participation in the IMPACT study is limited to carriers of BRCA1 and BRCA2 gene alterations which are known to be harmful. If more information becomes available to confirm the role of your VUS in cancer predisposition, at that time you will become eligible for this trial.

A17. I have a strong family history of prostate cancer, but no genetic (BRCA1/2) alteration has been found. I would like to take part in IMPACT. Am I eligible for this study?

Unfortunately, at the moment we are restricting access to IMPACT to confirmed carriers of BRCA1 or BRCA2 gene alterations. If, in future a BRCA alteration is found to be running within you family, then you could become eligible for this trial.

It is thought there may be other genes which predispose to

prostate cancer
development. The IMPACT study may, in future, be extended to investigate the role of other prostate cancer predisposition genes. It is possible that if one of these genes is identified as running within your family, that you may become eligible for the IMPACT study, but this is not likely to occur in the near future.

A18. What is the prostate specific antigen (PSA)?

PSA is a protein produced by the prostate.

A19. What is the prostate specific antigen (PSA) test?

The PSA test is a simple blood test which measures the total level of PSA in the blood. If the prostate becomes enlarged as a result of cancer, the amount of PSA produced by the prostate will increase. Unfortunately, however, the PSA test is not specific to cancer, and levels also rise if a person is suffering from benign (non-cancerous) conditions of the prostate such as benign prostatic hyperplasia and prostatitis.

A20. Why is there so much controversy over the use of the PSA test to screen for prostate cancer?

The controversy surrounding the use of PSA test as a screening test for prostate cancer is discussed in the diagnosis section of this website.

A21. Are there any alternative methods available to screen for prostate cancer?

At present the prostate specific antigen (PSA) test is the only test which is available to screen for prostate cancer. There is currently a lot of research being conducted into alternatives to the PSA test, many of which are based upon PSA, but use different calculations or measurements related to PSA (e.g. age-adjusted PSA, free to total fraction PSA, PSA density and PSA velocity). IMPACT will also be evaluating the use of these alternative tests as a prostate cancer screening tool.

A22. I am aware that in the UK the NHS suggests a threshold for biopsy of 4.0ng/ml, yet the IMPACT study is referring patients for biopsy if they have a PSA level of 3.0ng/ml. Why?

Because PSA is age related (i.e. PSA levels often rise as an individual becomes older), and we are recruiting a relatively young population of men, we have reduced the PSA threshold.

A23. If my PSA level is above 3.0ng/ml does this mean I have prostate cancer?

No, we expect that only 1 in 3 of men with a PSA level greater than 3.0ng/ml will have prostate cancer. When the PSA level is raised, however, further investigation is warranted to try to determine the cause of this increase.

A24. If my PSA level is below 3.0ng/ml does this mean I do not have prostate cancer?

No, unfortunately there have been a number of cases reported where men are found to have prostate cancer even though their PSA level is not above what is regarded as a normal level. Despite this, PSA is still the best screening test we have for prostate cancer, and can be used to diagnose prostate cancer in men who have no clinical symptoms.

A25. What happens during a prostate biopsy?

The doctor will feel your prostate gland by inserting a finger into your rectum (back passage). A specially shaped lubricated ultrasound probe, which is a little larger than a man’s finger, will be placed into the rectum. The probe uses ultrasound waves to produce an image of the prostate and the doctor will use the ultrasound to guide a needle through the wall of the rectum to take a tissue sample. Ten samples will be taken and looked at by a specialist doctor using a microscope to look for prostate cancer. With your permission we would like to take a further two tissue samples for research.

The procedure will be carried out in the out-patient clinic by an Urologist and a local anaesthetic will be injected beforehand. It takes about 45 minutes and most men describe it as uncomfortable and some describe it as painful. You will be given a short course of antibiotics immediately before, and after, the prostate biopsy to reduce the risk of infection and you will need to drink a lot of water for the next 24 hours. After the scan and biopsy you may notice blood in your urine which should clear within two to three days, but may continue for up to ten days or two weeks. You may also notice blood from your back passage which should settle within one to two days. Finally you may see blood in the semen which may last for several weeks. Please be aware that the sight of blood is to be expected after the biopsy and should not cause undue concern.

A26. What is a biopsy core?

A biopsy core is a small tissue sample taken from the prostate which will be sent for microscopic analysis by a pathologist who is looking for signs of prostate cancer.

A27 I have been identified as having PIN. What does this mean?

If, upon biopsy, the cells that line the ducts of the prostate are found to be abnormal, this is referred to as PIN (Prostatic Intraepithelial Neoplasia). PIN is not regarded as a disease, and therefore does not require treatment. Two different forms of PIN exist, high-grade and low-grade, and urologist often consider it necessary investigate further if a patient is diagnosed with high-grade PIN. This is because PIN can occasionally develop into prostate cancer.

For the IMPACT study, any participant diagnosed with high-grade PIN will be referred for a second biopsy after six weeks, the results of which will decide whether the participant should continue with annual PSA testing, or undergo further treatment or investigation.

A28 I have been told that ten cores will be taken when I undergo my prostate biopsy, and two extra for research purposes. Why are the extra two required?

We would like to take tissue samples to use for research to help us to develop new screening tests for prostate cancer.

A29. I have a PSA level which is over 3.0ng/ml, but I had a normal prostate biopsy. Why am I not being referred for another biopsy, despite my high PSA level?

PSA levels can be raised for a number of reasons, other than the presence of prostate cancer, and only 1 in 3 men with a raised PSA will be found to have cancer at prostate biopsy. During biopsy 10 samples of prostate tissue are taken and analysed under the microscope. These are taken from all areas of the prostate and it is very unusual for a cancer to be present that has not been picked up on biopsy. Therefore, we will monitor your condition at your next annual visit, and watch for trends in your PSA. If your PSA level starts to rise rapidly we will discuss the option of undertaking another biopsy with you.

A30. I have read that there is a chance that cancer cells can be missed during biopsy. Why does this happen?

Unfortunately, even if there is a cancer in the prostate gland it may not be picked up on prostate biopsy. During biopsy 10 biopsy cores are taken from the prostate which will be examined under a microscope for signs of prostate cancer. Doctors can use an ultrasound probe to guide the biopsy needle and collect tissue sample from a cross-section of the prostate, but because it is not possible to sample the whole of the prostate, it is possible that some cancerous tissue may be missed. For this reason, your PSA level will be monitored carefully on a yearly basis. We will watch for trends in your PSA and if your level starts to rise rapidly, we will discuss the option of undertaking another biopsy with you.

A31. If prostate cancer is diagnosed, what happens next?

If you are found to have prostate cancer you will discuss all of the treatment options with a specialist. The best way to treat early prostate cancer is not known and there is no proof that treating early prostate cancers helps men to live any longer than simply having regular check-ups. However, treating some cancers while they are still small may stop them from spreading and causing problems.

Many prostate cancers grow very slowly, and the side effects of treatment may be worse than the effects of early prostate cancer, so it can be difficult to decide whether or not to have treatment. You will be given the chance to discuss all of your treatment options with a specialist, and any course of treatment will be tailored to suit your specific needs.

For a summary of prostate cancer treatment options please refer to the Treatment section of this website.