Download What happens if I want to stop being involved in this study?

Information sheet 2 (Version 5 – 30th July 2005)
ProtecT study
(Prostate testing for cancer and Treatment)
Mr David Gillatt
Bristol Urological Inst.
Southmead Hospital
0117 9595080
Prof Freddie Hamdy
Section of Urology
University of Sheffield
0114 271 2154
Prof Jenny Donovan
Dept. Social Medicine
University of Bristol
0117 928 7214
Prof David Neal
Surgical Oncology
University of Cambridge
01223 331 940
Lead Nurse
ProtecT study
Southmead Hospital
0117 9595080
The tests done so far show that you have got cancer of the prostate. This news probably came as a bit of
a surprise at first and so we have written this information sheet to help you understand what this means
and what you can do next. We have examined your test results and can tell you that you have localised
prostate cancer (that is, we think the cancer is contained inside the prostate gland). It is important that
you know that most men with this kind of cancer will be alive and healthy for very many years as the
cancer will grow very slowly. However, some men will have cancer that grows more quickly and they will
become ill or die as a result of having prostate cancer. You have been assessed by the medical team to
be suitable for the standard treatments (monitoring, radiotherapy and surgery). At the moment, however,
no-one knows which of these treatments would be best for you because we cannot tell whether your
prostate cancer will cause you harm or not in the future. This is why we need to do the ProtecT study.
WHAT IS THE PURPOSE OF THE PROTECT STUDY ?
The ProtecT study is about the best way of treating localised prostate cancer. It is currently difficult to
predict which treatment is best for an individual. It is likely that some would benefit from more aggressive
treatment, such as surgery or radiotherapy, whereas others would benefit from a more conservative
approach, such as careful monitoring with regular blood tests and check-ups. There are advantages and
disadvantages with each of the treatments. The best way to compare the treatments is to have similar
groups of men having each of the treatments. The best way to achieve this is for each man to have his
treatment decided upon by chance – ‘randomisation’. This way, each man will have an equal opportunity
to have any of the treatments. The treatment groups will then be similar and we can make a fair
comparison between them and provide clear advice to men in the future.
WHY HAVE I BEEN CHOSEN ?
You have been chosen because you have prostate cancer that appears to be contained inside the
prostate gland. This means that you are suitable for monitoring, surgery or radiotherapy.
DO I HAVE TO TAKE PART ?
It is up to you to decide whether or not to continue to take part in the ProtecT study. If you do decide to
take part you will be given this information sheet to keep and asked to sign a consent form. If you do
decide to take part you will still be free to withdraw at any time and without giving a reason. A decision to
withdraw at any time, or not to take part, will not in any way affect the standard of care you receive.
WHAT WILL HAPPEN TO ME IF I TAKE PART ?
You have been invited to discuss the study and the treatments in detail with a research nurse at an
‘information’ appointment. So that we can evaluate the information, we will ask if we can tape-record your
appointment. We have given you this sheet so that you have some information about the study and will
be prepared for your discussions with the nurse. During the information appointment, the nurse will go
through each of the treatments and then discuss with you whether you are willing to continue with the
study. Remember - you could have monitoring, surgery or radiotherapy – your test results show that all
these treatments would be suitable for you.
WHAT DO I HAVE TO DO?
When you attend the information appointment, the research nurse will explain to you in detail the three
treatment options, and their potential advantages, disadvantages and risks involved. In order to give you
preliminary concise information, we have summarised this information as follows:
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THE TREATMENTS (SEE ALSO CHART ON PAGE 6)
Surgery (radical prostatectomy)
Radical prostatectomy is an operation which aims to remove the cancer completely. You will be assessed
beforehand with routine tests. If you have other health problems that might increase risks from an
operation, a consultant anaesthetist will also assess you, and you will have the opportunity to discuss
things with the surgeon again. The main advantage of the operation is that the cancer and the prostate
gland can be removed completely, although we are not certain whether this makes any difference in the
long term in prolonging or improving your life. The operation itself lasts between 3-4 hours, and you will
be in hospital for 4-7 days. The surgeon will make an incision in the lower part of your abdomen (belly).
He will remove first some lymph glands from the side of the prostate. The surgeon then proceeds with
removing your prostate, and joins the neck of the bladder to your pipe (urethra) so that you can pass
urine normally. A tube (catheter) is left in place for 7-15 days to allow the urine to drain and the wound to
heal. A small number of men, for example those with a PSA over 10ng/ml, will need to have the lymph
nodes tested by the pathologist before the main operation takes place. If the lymph nodes are diseased,
the prostate will not be removed, and different treatments will be required. The surgeon will discuss this
with you in detail before the operation if this is likely in your case.
The operation is very safe, and will be performed by a surgeon who is skilled and experienced. As with
any operation, there are very small risks of general complications, such as bleeding, infections and, very
rarely death (less than 2 in 1000). More specifically, you may experience some loss of control in passing
your urine, which tends to settle by 3-6 months after the surgery, and could require wearing pads. Very
few men have a long-term problem with incontinence (less than 5 in 100), which may require other
treatments. You may find that you have difficulty in achieving an erection spontaneously to have sex. The
risk of having difficulties with erections can be as low as 1 in 5, or as high as 4 in 5. This depends on a
number of factors, including your level of sexual activity before the surgery, and whether it is possible for
the surgeon to save the nerves running alongside the prostate. Should you have problems with erections,
this can be helped with a choice of treatments, ranging from tablets to injections. It is unlikely that you will
lose your urge to have sex.
If after the operation, examination of the prostate under the microscope shows that the cancer had grown
beyond the covering of the gland, the surgeon will discuss with you whether you need additional
treatment such as radiotherapy and/or hormones. After surgery, your PSA level will be monitored at
regular intervals and is expected to be close to zero. The majority of men will not require further
treatment, but in a small number the cancer will not have been completely removed and further treatment
may be needed.
Radiotherapy (radical conformal radiotherapy)
Radiotherapy aims to destroy the cancer cells with carefully controlled radiation. You will have hormone
treatment first to try to shrink the cancer. In the specialist centre, you will have a scan to outline your
prostate and other organs. Radiotherapists will then plan the treatment that you need. When you have
the radiotherapy, you will be kept still and a machine radiates the prostate where the cancer is. The
treatment takes 10-15 minutes, five times a week, usually for 6-8 weeks. Staff at the centre will try to find
a time that suits your other commitments. Most people tolerate radiation treatment well. The main
advantage is that radiotherapy aims to destroy the cancer and leaves the prostate remaining in place.
However, it has some complications. The risk is mostly of damage to neighbouring parts of your body, so
that you might have inflammation or damage to your bladder or bowel during the treatment (between 3
out of 10 and 4 out of 10). You may have some diarrhoea and feel tired or nauseous during the treatment.
The hormone treatment reduces the level of your male hormone, testosterone, and so it is likely that you
will lose your interest in sex and your ability to have erections while you are having hormone therapy.
Your erections should return when you stop taking hormones. There is a longer-term risk of impotence as
a result of radiotherapy – affecting about 4 out of 10 patients having radiotherapy. About 1 in 10 men may
experience some dribbling of urine. There is a small increased risk of developing cancer in other areas
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(such as the rectum) as a result of radiotherapy. After radiotherapy treatment, your PSA level will be
monitored and should fall over time and stay at a low level. The majority of men will not require further
treatment, but in a small number the cancer will not have been completely destroyed and further
treatment may be needed.
Active monitoring
The aim of active monitoring is to assess the behaviour of the cancer so that we can find out whether it is
likely to grow quickly or slowly over time and thus cause problems or not. If you have active monitoring,
you will see a doctor (urologist) or a nurse regularly to have a check-up and a PSA blood test. At first you
will be seen every 3 months. The PSA level from each blood test will be plotted on a graph so you can
see what is happening and discuss this with the nurse. If the PSA level stays stable, you will be able to
have six-monthly or yearly check-ups for as long as you like and you may not ever need to receive any
other treatment. Sometimes the PSA level will rise steeply, but at the next appointment it may come down
again – this is quite common. If the PSA level rises consistently or quickly – for example going up by 50%
in any 12 month period - the nurse or doctor will suggest further tests to see if the cancer has grown. If
the tests suggest that the cancer is still inside the prostate, you could have radical surgery or radiotherapy
or remain on active monitoring. If the cancer has spread, it would probably not be possible then to
remove or destroy the cancer with radical surgery or radiotherapy. If this happens, you might need
radiotherapy, hormone treatment or a combination of these treatments.
The main advantage of active monitoring is that there is no treatment straight away. This means that
there are no immediate side effects, although you will know that you have cancer and will be reminded of
this when you have your PSA tests. There is a good chance that you will not ever need any other
treatment as you get older. On the other hand, we know that PSA testing is not perfectly reliable. It is
possible that the cancer will spread in the future and you will then need treatment. It is possible that it
can spread without the PSA going up. The worst possibility is that the cancer will continue to grow and
you might then need hormone treatment to try to halt the spread. If the cancer continues to grow and
spread it could be fatal. A study from Scandinavia has shown that men diagnosed with prostate cancer
when they have symptoms and have surgery do better than those not treated and followed up 10 years
later. However, the Scandinavian study is different from the ProtecT study in two major ways: first, the
Scandinavian men were not invited for a PSA test initially as you were, and so their cancer was probably
further advanced; second, they were not followed up regularly with active monitoring and so were not
offered treatment before the cancer started to spread. At the moment, no-one is able to tell which of the
prostate cancers that are found following PSA testing will spread in the future. The risk of spread is
greater for those with high rather than low grade and stage disease. We expect that for most men the
regular check-ups and active PSA monitoring will detect early on whether the cancer is growing quickly.
In the ProtecT study, our aim is to enable you to receive treatment when you need it. However, some
cancers may develop quickly or spread without this early warning.
The ProtecT study
It is important to remember that most men with prostate cancer generally live a long time and without
problems related to their prostate cancer whichever treatment they have. Each treatment has
advantages and disadvantages, and that is why we are carrying out the study – to try to find out in the
future which treatment is best for which patient. After the treatments are explained to you, the nurse will
ask you if you wish to continue with the study. The study involves you agreeing to have your treatment
decided upon by chance: a process called ‘randomisation’. This process ensures that the treatments are
compared fully and fairly. If you agree, the nurse will ring the research centre. The research centre will
then enter your details into a computer and your treatment will be selected by chance – you will have an
equal chance of having any of the treatments. The nurse will tell you the treatment straight away. It is
important for the study that you only agree to be randomised if you believe you would be prepared to
accept the treatment assigned to you by the study. This is important because only data from men who are
randomised can be used in the most important analyses to determine future policy for men with prostate
cancer. You should continue to discuss randomisation and the treatments with the nurse until you are
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sure all your questions have been answered. You will be given as much time as you need and will be
able to ask all the questions you want.
It is best for the study that as many men as possible agree to be randomised and accept the treatment
allocated to them. However, if you are not sure when the nurse tells you the treatment allocation that you
can accept it straight away, you will be able to discuss the treatment further with the nurse or see a doctor
who specialises in the treatment. If you do not want to have your treatment decided by randomisation,
you will be able to discuss the treatment options with the nurse (or a doctor).
We will ask you to attend for follow-up appointments and to fill in questionnaires for the ProtecT study
whatever treatment you have and however the treatment is decided. All these data will contribute to
improving our understanding of prostate cancer and treatment, but the most useful data comparing the
treatments will be provided by those agreeing to randomisation and accepting the treatment. The ProtecT
study is committed to providing you with the information you need to understand the advantages and
disadvantages of randomisation and each of the treatments and to ensure you are comfortable with the
treatment you have. Your care will not be affected by the way the treatment is decided.
WHY CAN’T THE DOCTOR OR NURSE CHOOSE THE BEST TREATMENT FOR ME?
We would like this to be the case, but at the moment we do not know which treatment is best for which
patient. We need to have studies that allow us to compare the advantages and disadvantages of the
treatments and find out what men feel about these. At the moment, we do not have this evidence and
this is why we are doing the study.
WHAT HAPPENS IF I WANT TO CHOOSE WHICH TREATMENT I HAVE?
At the end of the discussion, you may feel that you want to choose between treatments for yourself. If
you choose a treatment, we would still ask you to carry on completing the questionnaires to help us
understand how your treatment affects you.
WHAT HAPPENS IF I WANT TO STOP BEING INVOLVED IN THIS STUDY?
At any stage you can decide to stop helping with the study. Your doctor will look after you in the same as
if the study were not happening. Withdrawing from the study will not affect your treatment in any way.
WHAT IS THE PROCEDURE THAT IS BEING TESTED?
We are trying to identify the best treatment for patients with localised prostate cancer, by comparing the
long-term outcome of the various options. They are all conventional options that would be offered to you if
you were not in the study. There is nothing experimental in the study that we are doing.
WHAT ARE THE ALTERNATIVES FOR TREATMENT?
The conventional treatments are all available within the study. There are several newer treatments that
you may have heard of such as freezing or heating the prostate (cryotherapy or hyperthermia), or
implanting radio-active seeds (brachytherapy). At present, prostate brachytherapy is not widely available.
It has been used in the UK for less than 10 years so we do not know the long-term outcomes yet. The
procedure involves placing radioactive seeds of Iodine 125 directly into the prostate gland through fine
needles under ultrasound guidance. This requires a two-stage procedure. First, a planning scan is carried
out two weeks before treatment with a general anaesthetic as a day case. The placing of the radioactive
seeds is then done under a general anaesthetic, and approximately 100 seeds are delivered via about 30
fine needles. The procedure lasts about an hour and patients go home the next morning. As with all
options there are advantages and disadvantages. It is a quick procedure that allows rapid resumption of
normal activity. There may be lower risks of inflammation of the rectum compared with conventional
radiotherapy. There can be irritation to the urethra (the water pipe), but less irritation to the bladder
compared with conventional radiotherapy. There is postoperative bruising and discomfort for a few days.
The irritation to the urethra can cause retention of urine (a stoppage) which requires the insertion of a
catheter in the urethra in between 3 to 10 in a hundred men. Men commonly notice some reduced flow of
urine so all men are advised to take a tablet daily to help them. The urinary symptoms commonly last 3-6
months before returning to normal, but in 1 man in 10 they last up to at least one year. If you are potent
prior to the procedure there is a 7 out of 10 chance you will have normal erections after the procedure.
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The amount of seminal fluid made at orgasm is however frequently reduced after this procedure.
Brachytherapy is not suitable for all men in the ProtecT study, and is not available in every centre. If you
would like further information or wish to know if you are suitable, please ask the research nurse.
WHAT ARE THE SIDE EFFECTS OF ANY TREATMENT RECEIVED WHEN TAKING PART?
We have listed the potential side effects and their relative frequency in the table overleaf. Please read
them carefully, and ask as many questions as you wish regarding these issues at your next appointment.
WHAT ARE THE POSSIBLE DISADVANTAGES AND RISKS OF TAKING PART?
The disadvantages include the anxiety caused by the dilemmas associated with treatment options. The
risks are those of receiving unnecessary treatment for localised prostate cancer with its potential side
effects, and those associated with monitoring and delaying treatment if the disease requires intervention.
The risks are detailed in the table overleaf.
WHAT ARE THE POSSIBLE BENEFITS OF TAKING PART?
The benefits include the knowledge that you have a cancer which could be treated by the three treatment
options. It is possible that early treatment may benefit you long-term, or that monitoring stable disease
would protect you from the potential side effects of treatment. In addition, the information from the study
will help us in the future to treat patients with prostate cancer better.
WHAT HAPPENS IF NEW INFORMATION BECOMES AVAILABLE?
Sometimes during the course of a research project, new treatments become available. If this happens
and the treatment is appropriate for you, the doctor will tell you about it and discuss with you whether you
can have this treatment within the study or whether you will need to withdraw from it. If you withdraw, the
doctor will ensure that your care continues.
WHAT HAPPENS WHEN THE RESEARCH STUDY STOPS?
Irrespective of the research stopping, you will be followed up for life just like any other patients under our
care who have prostate cancer.
WHAT HAPPENS IF THE CANCER SPREADS OR COMES BACK?
If at any stage in the future, whatever treatment you have had, the cancer is found to have spread, you
will be able to discuss things with the doctor and have the most suitable treatment immediately. We will
ensure that you are seen regularly as part of the study, and this should help us to detect any spread of
the cancer at an early stage.
WHAT IF SOMETHING ELSE GOES WRONG?
If you are harmed by taking part in this research project, there are no special compensation
arrangements. If you are harmed due to someone’s negligence, then you may have grounds for a legal
action, but you may have to pay for it. Regardless of this, if you wish to complain, or have any concerns
about any aspect of the way you have been approached or treated during the course of this study, the
normal National Health Service complaints mechanisms should be available to you.
WHO IS ORGANISING AND FUNDING THE RESEARCH?
The NHS is funding the ProtecT study through its Health Technology Assessment Programme.
WHAT IF I HAVE OTHER CONCERNS?
You will have plenty of time to discuss all the issues involved in this research at your information
appointment. If you want more time to think, or you would like another appointment to talk to a different
nurse or doctor, you will be able to do this. Please discuss this at your information appointment. If you
want to talk to someone about the study, please contact one of the following:
Emma Elliot / Hilary Moody
or
Dr Athene Lane
Lead Nurses
Study co-ordinator
Southmead Hospital
Department of Social Medicine
Bristol
University of Bristol, Bristol BS8 2PR
Tel: 0117 9595080
Tel:01179287335
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SUMMARY OF CURRENT EVIDENCE ABOUT SIDE EFFECTS AND BENEFITS OF TREATMENT
It is difficult to be precise about some of the risks and benefits of the treatments. That is why we are
carrying out the ProtecT study – to ensure that we have this information for the future. We have made
‘best-guess’ estimates based on world-wide research.
Treatment
What it entails
Possible
Possible disadvantages
advantages
Radical
Surgical operation taking 3-4
Removal of cancer
Risks related to any operation: e.g. blood
prostatectomy
hours. Lymph glands and
and potential for
loss/clots, infection, death - rare: less than
prostate gland removed and
cure
2 in 1000.
urethra rejoined to bladder.
Impotence: risk depends on level of
Catheter in urethra during
sexual activity and damage to nerves
hospital stay to drain urine and
during operation. If no damage, may be 1
help heal join. Stay in hospital
in 5; with damage may be 4 in 5.
for 4-7 days.
Incontinence: 1 in 2 some dribbling
needing pads, usually going by 3-6
months. 2-5 out of 100 ‘severe’
incontinence needing treatment e.g.
artificial sphincter.
Radical
Radiotherapy lasting 10-15
Eradication of
Inflammation of bowel or bladder, causing
radiotherapy
minutes, 5 days per week for 6-
cancer without
diarrhoea and urinary symptoms;
8 weeks.
removing prostate
tiredness or nausea: 3 or 4 out of 10.
Simultaneous hormone
and potential for
Usually temporary.
treatment will be given for six
cure
Impotence: complete impotence during
months only to shrink the
period of treatment with hormones. 4 out
cancer.
of 10 impotent after treatment.
Incontinence: 1 out of 10 ‘dribbling’ urine.
Active
Being seen by a nurse or
No immediate
Knowing that you have cancer and the risk
monitoring
urologist and having PSA tests
treatment or
of the cancer spreading over time. If this
regularly – at first every 3
complications.
happens and the disease is still inside the
months, then every 6 or 12
Possibility of never
gland, radical surgery or radiotherapy may
months.
needing treatment.
be possible. If the cancer has spread,
radiotherapy and/or hormone treatment
may be needed. The worst-case scenario
is that the cancer will spread and cause
symptoms, even death. The risk is higher
for those with high grade and stage
disease. Regular monitoring of PSA levels
should ensure we discover fast growing
cancers early in most cases and start
treatment when needed. Some cancers
will spread without this early warning.
NB There is a risk that the cancer may spread following any of the treatments. If it does spread, you may
need hormone and/or radiotherapy treatment and treatment for symptoms that occur. Regular monitoring
of PSA levels should ensure that we have early warning of the spread of the cancer in most cases and
can then offer you the most appropriate treatment.
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