Download Biopsy - IMPACT Study

The IMPACT Study - The IMPACT Study - Identification of Men with a genetic
predisposition to ProstAte Cancer: Targeted screening in men at higher genetic
risk and controls –
Patient Information Sheet – Prostate Biopsy
Thank you for taking part in the IMPACT study. You have now completed the five year’s
of screening within the study. We would like to invite all men who have taken part in the
study to consider having a prostate biopsy as part of the research. Before you decide
you need to understand why we are offering you this and what it would involve for you.
Please take time to read the following information carefully and discuss it with others, the
study team and your GP if you wish. Ask us if there is anything that is not clear or if you
would like more information.
Background
Research has shown that men who have an alteration in the Breast Cancer 1 (BRCA1)
or Breast Cancer 2 (BRCA2) genes are at a higher risk of developing prostate cancer.
The aim of the IMPACT study is to look at methods of early detection of prostate cancer
in men at a higher risk and compare this with a control group. You will have been taking
part in this study either because you have been found to have an alteration in BRCA1 or
BRCA2, or because you are acting as ‘a control’. Men in the control group have had a
genetic test for an alteration known to be present within their family and this test has
been negative. Having a control group will enable us to compare the measurements
that we will take in this study in people who have an increased risk of prostate cancer
(those with the genetic alteration) and those who are currently thought to have the same
risk as the general population (the controls).
Why am I being invited to have a biopsy?
You are being invited to have a biopsy of your prostate gland as part of your participation
in the IMPACT study. You have been having annual Prostate Specific Antigen (PSA)
blood tests. PSA testing is currently the best tool for early detection of prostate cancer
but there is a lot of controversy amongst experts about whether the PSA test is helpful in
diagnosing prostate cancer. It is not a perfect test and approximately two out of three
men with a raised PSA level will not have prostate cancer. The PSA test can also miss
prostate cancer, and several studies have shown that a number of men with a normal
PSA level actually have cancerous cells present in the prostate gland.
A biopsy is a more accurate test for prostate cancer than PSA but is more invasive than
a blood test. A biopsy is where cells are taken directly from the prostate gland and they
are looked at under a microscope to see if there is any cancer present. It is possible that
a biopsy can also miss prostate cancer in a very small number of cases.
What does a prostate biopsy involve?
The doctor can 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
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man’s finger is 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 from the
prostate gland 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 biopsy will be carried out in the out-patient clinic by a specialist doctor and 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 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 read the following table
carefully as you need to be aware of the potential limitations and complications of having
a biopsy:
Potential limitation and complications of having a prostate biopsy
1. Discomfort
Most men describe the biopsy as an uncomfortable experience
and some describe it as painful
2. Anxiety
The biopsy procedure can cause significant anxiety, particularly
while you are waiting for the results.
3. A cancer may be missed
A very small number of cancers may be missed at biopsy. This is
termed a “false negative” result.
4. Infection
There is a 3% chance that a significant infection will occur
following the biopsy and antibiotics will be given before and after
the procedure to reduce this risk.
5. Bleeding
Approximately one third of men will experience some bleeding
when passing water, opening their bowels or after sex following
the biopsy
5. Threat to life
It is extremely unlikely, but as with any invasive procedure, there
is always a rare chance that complications could arise that are lifethreatening. The risk of death is estimated to be less than 1 in
40,000.
Is there anything I should do before the scan?
There is a high risk of developing an infection after a prostate biopsy has been taken.
Therefore, you will be prescribed a course of antibiotics to reduce this risk. If you have
any allergies you must discuss these with the study. If you are taking any blood thinning
tablets (for example Aspirin or Warfarin) then you will also need to discuss this with the
team.
Do I have to take part?
Taking part in this additional part of the IMPACT study is voluntary and it is up to you to
decide whether to take part or not. We will describe what a biopsy involves and go
through this information sheet, which we will then give to you. If you decide to have the
biopsy we will then ask you to sign a consent form to show you have agreed to take part.
If you decide to take part you are free to withdraw at any time and without giving a
reason. This would not affect the standard of care you receive.
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Your legal rights are not affected by your giving consent to have a biopsy. As with all of
the information you have provided to date, any personal information collected in the
IMPACT study, including specimens we may obtain from you, will remain strictly
confidential. Before agreeing to take part in this additional part of the study you should
check that any private medical insurance you have will not be affected by you taking
part.
What will happen to me if I take part?
If you decide to take part then a member of the research team will telephone you to
discuss any questions you may have about the biopsy. You will then be offered an
appointment for the biopsy to take place. You will need to attend for a total of two outpatient appointments, one to have the biopsy and one approximately 3 weeks later to
discuss the results of the biopsy. Any travel expenses incurred as a result of taking part
in this study will be reimbursed.
What will happen if I am found to have prostate cancer on the biopsy?
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. There are three main
treatment options for treating prostate cancer – Radiotherapy, Surgery and Active
Monitoring. All of these options will be discussed with you by a specialist and tailored to
suit your specific needs.
What are the possible benefits of taking part?
There may be no direct benefits to you as an individual. The detection of early prostate
cancer that would otherwise never have caused symptoms may result in anxiety and
side effects of treatment. Conversely, it is possible that we may find results detecting
prostate cancer that would otherwise have remained undetected until it caused
symptoms; this could then be treated earlier.
The results of this study will help us to develop our knowledge and understanding about
the genetic causes of prostate cancer and help us to identify men who may be at higher
risk of developing prostate cancer. The results of this research may lead us to develop
new detection tests and new ways of undertaking prostate cancer screening.
What are the possible disadvantages of taking part?
The possible side-effects of the biopsy are detailed above. Some people may
experience anxiety as a result of the biopsy and support is available (see below).
What support will there be for me if I decide to take part?
The study team of doctors and nurses will be your first contact point for advice and
support (contact details below). Their role is to support you during and after taking part
in the study. They will refer you to a nurse specialist or to a psychological counsellor if
required.
What will happen to me after I have completed the study?
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If you are found to have prostate cancer then you will be treated by a specialist team and
we will stay in contact with you and your team to find out more about the treatment that
you are receiving.
If your biopsy is clear then we will discuss the best way for you to be followed up after
the study has finished. This will depend on the results of the study tests. We may
recommend further screening tests which will usually be organised through your GP.
We would also like to write to you once a year with a short questionnaire that will tell us
about any changes to your health. If there are any improvements in our knowledge
about the results of your genetic analysis then we will update you in this letter.
Will my taking part in the study be kept confidential?
If you decide to take part in the research an authorised member of staff may inspect your
medical records for the purposes of analysing the results. Any information you give us
will be kept strictly confidential and no member of your family will be contacted by us,
except through yourself. Information is stored on a database adhering to guidelines set
out in the Data Protection Act. All specimens obtained from you will be stored using
identifying codes that will be known only by the research team.
Who should I contact for more information about this study?
If there is anything that is not clear or you would simply like more information please
contact Liz Bancroft 0207 808 2136 or Natalie Taylor 02070 661 3643
We would like to thank you for reading this information sheet.
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