Download PIS General Part 1 v15.0 Jul-2016 - clean

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STAMPEDE TRIAL
We are inviting you to take part in a study
called STAMPEDE
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Your doctor has explained to you that you have
prostate cancer and has invited you to
participate in this study.
Before you decide, it is important for you to
understand why the research is being done and
what it will involve.
Please take time to read the following
information carefully. Discuss it with friends and
relatives if you wish.
Take time to decide whether or not you would
like to take part in this study. Participation is
entirely voluntary. This decision is up to you. If
you decide not to take part, this will not affect
the care you get from your doctors in any way.
You can decide to stop taking part in the study at
any time, without giving a reason.
Please just ask if there is anything that is not
clear or if you would like more information.
Thank you for reading this information. If you
decide to take part you will be given a copy of
this information sheet for you to keep. You will
also be asked to sign a consent form; you’ll get a
copy of that to keep as well.
This sheet should be read with the General
Patient Information Sheet Part 2 and Treatment
Specific Information Sheets.
V15.0PIS General Part 1 Jul-2016
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Contents
1 Why are we doing this study?
2 How is the research done?
3 What do I need to know about the
treatments used in this study?
4 Can I receive radiotherapy as my
standard treatment?
5 Can I also receive chemotherapy
(docetaxel)?
6 Do I have to take part in the study?
7 What are the possible advantages of
taking part?
8 What are the possible disadvantages
of taking part?
9 Will I need extra tests?
10 What follow up care should I expect?
11 Some things to read
How to contact us
If you have any questions about this
study, please talk to your doctor or
nurse:
Name of doctor or nurse
Hospital Department
Hospital
Address
Address
Tel: XXXXXXXX XXX
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1
Why are we doing this study?
This study is called STAMPEDE (Systemic
Therapy in Advancing or Metastatic Prostate
Cancer: Evaluation of Drug Efficacy) and
looks at the effect of adding new or different
treatments to the standard way in which
prostate cancer is currently managed.
The standard treatment for prostate cancer
involves hormone treatment and may also
include chemotherapy and/or radiotherapy.
Prostate cancer needs the male hormone
testosterone to grow. Hormone treatments
work by stopping testosterone from reaching
prostate cancer cells. There are different types
of hormone treatments but the most common
are injections or implants that work by
stopping the testicles making testosterone.
Some men will have an operation to remove a
part or all of the testicles instead.
Your doctor may also discuss chemotherapy or
radiotherapy as part of your standard
treatment (see Sections 4 and 5 for more
details).
This study aims to see if, by adding new or
different treatments to the standard approach,
we can improve the way in which prostate
cancer is currently managed and enable men to
live longer and enjoy a better quality of life.
We would like your consent to carry out a small
number of additional tests to help us do this.
One of these blood tests will check if you have
diabetes. The clinical research team at your
local hospital will let you know the results of
this test and confirm whether you have
diabetes or not. If you do, your GP will be
informed and treatment to manage your
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diabetes will be prescribed as per standard
clinical care.
This study will also aim to find out more about
how prostate cancer grows and becomes
resistant to treatment.
For more information on this please read the
information sheet entitled Additional Research
Patient Information Sheet.
2
How is the research done?
The best way of knowing whether one
treatment is better than another is by carrying
out a “randomised controlled trial”. These
types of studies aim to make a fair comparison
between new treatments and the existing
treatment to see which one works best.
A randomised controlled trial compares two or
more groups of people: a research group who
receive the new ‘research’ treatment and a
control group who receive the existing
‘standard’ treatment. This allows researchers
to see whether the new treatment is better
than the existing treatment. In this information
sheet, the term “study” and “clinical trial” will
be used interchangeably and they are intended
to mean the same thing.
If you take part in the study, a computer will
randomly decide which treatment group you
will join. This ensures the groups are as similar
as possible, except for the treatment they
receive. This is important to enable a fair
comparison. As neither you nor your doctor can
decide which group you join, if you choose to
take part, you must be willing to accept
whichever treatment group you are allocated
to.
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This study has been running since 2005 and has
compared 8 different treatment approaches so
far. We expect to include over 9,000 men like
you in the study. They will be treated at
hospitals all across the UK and internationally.
We expect to take between 6 and 10 years to
complete recruitment to the study and for
results to become available.
3
What do I need to know about
the treatments in this study?
All men taking part in the study will receive
standard treatment. This will include hormone
treatment and may also include radiotherapy
and chemotherapy (see Sections 4 and 5).
Your doctor will talk to you about what your
standard treatment will involve. This will
remain unchanged whether or not you choose
to join the study. We have called the men who
receive standard treatment alone Treatment
Group A (the control group).
All research treatments are given in addition to
standard treatment. There is currently 1
research group open that men may join, this is
named Treatment Group K.
All men allocated to Treatment Group K will
receive metformin in addition to standard
treatment. Metformin is a diabetic treatment
that may also have an effect on prostate cancer
growth and help prevent some of the side
effects of hormone treatment. Only men with
no diabetes can join Treatment Group K,
therefore all men wishing to take part must
have a blood test to check for diabetes first.
You could be randomised to either treatment
group. For every 2 men joining the study, on
average, 1 will be allocated to Treatment Group
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A (the control group), and 1 to Treatment
Group K.
This is shown in Figure 1 on page 8.
Your doctor or nurse will discuss which
Treatment Groups you may join. Further details
about these treatments are given in the
treatment specific patient information sheets.
For your information, this study previously
looked at other treatments (Groups B, C, D, E,
F, G,J and H). It is no longer possible to join
these groups as we already have enough men
to test these treatments. Results for Treatment
Groups B, C and E were presented at an
international cancer conference in June 2015
and a summary can be found on the study
website, if you would like to read about what
we found.
4
Can I receive radiotherapy as
my standard treatment?
Recent research has shown us that there are
some groups of men who benefit from
radiotherapy. Because of this it is now
recommended as part of standard treatment if:
(i) You have disease that remains within the
prostate or
(ii) Your disease is within the prostate and
lymph glands nearby in the pelvis.
Your clinical oncologist (radiotherapy doctor)
will discuss whether this is suitable for you.
If you have radiotherapy it should start around
4-6 months after you have started hormone
treatment. Radiotherapy treatment is typically
given over a 4-7 week period and this will be
discussed in more detail by the radiotherapy
team.
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5
Can I also receive
chemotherapy (docetaxel)?
Recent results from STAMPEDE and another
study (CHAARTED) have shown that, in men
starting long-term hormonal therapy for the
first time, adding chemotherapy controls
prostate cancer for longer and in both studies,
men who received chemotherapy lived longer.
You and your doctor should discuss if docetaxel
chemotherapy is recommended for you.
If you and your doctor decide to use
chemotherapy it should start no more than 12
weeks after you start hormone treatment. Your
doctor or nurse will give you more detailed
information about docetaxel if this is to be part
of your standard treatment.
You can participate in the study regardless of
whether you and your doctor decide to use
chemotherapy in your treatment but you must
make this decision before joining the study.
6
Do I have to take part in the
study?
Your participation in the STAMPEDE trial is
entirely voluntary. If you decide not to take
part, your decision will be accepted without
question and your standard treatment will not
be affected in any way.
If you decide you would like to take part in the
study you are free to stop the research
treatment at any time without giving your
reasons and without affecting your future care.
7
What are the possible
advantages of taking part?
We hope that the additional treatments that
you may receive will help control your prostate
cancer better than the current standard
approach; however, this is not certain which is
why it has to be tested in a clinical trial.
Also, although by taking part in the study, you
may not directly benefit, this research will help
improve our understanding of prostate cancer
and hopefully led to better treatments for men
like you in the future.
8
Where are the possible
disadvantages of taking part?
In this clinical trial you may receive extra
treatments which will mean you are very likely
to have extra side-effects. The most common
unwanted side effects are described in the
Treatment Specific Information Sheets (Arm A,
and Arm K).
Being part of a clinical trial will also mean you
will need some extra hospital visits and blood
tests. If you want to know more, please read
the next section.
9
Will I need extra tests?
If you are considering joining STAMPEDE and
you do not have known diabetes then you will
need to have a blood test to check this first.
If your blood tests are abnormal you will be
referred to your GP to discuss this further. Not
all people with diabetes have symptoms and
V15.0PIS General Part 1 Jul-2016
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therefore it is possible that this will be picked
up early. This will enable you to receive
appropriate advice and treatment. Should you
have diabetes, depending on your stage of
prostate cancer you may not be able to join the
study (see Section 3).
stroke, peripheral vascular disease (blood
supply to other parts of the body) and diabetes.
If you have already been diagnosed with
diabetes then you do not need extra tests. All
other tests required by the study are part of
standard practice.
 Heart problems e.g heart attack or angina
(chest pain)
10
What follow up care should I
expect?
In order to assess the long-term effects of
treatment the study needs to collect follow-up
information. Your research team will need to
assess you regularly in order to update the
study team as to your progress.
Whichever Treatment Group you join, this will
likely mean a hospital visit at least every 3
months for the next 2 years and then every 6
months. Once we reach 5 years after you
joined the study, the research team will only
need to review your progress once a year.
However, if you are receiving metformin you
will need to attend more regularly in order to
pick up your tablets.
Please make sure you let the study team know
if you are admitted into hospital for any reason
and if you develop any of the following medical
conditions:
 Stroke or transient ischaemic attack (TIA or
“mini-stroke”)
 Peripheral vascular disease (“claudication”)
 Diabetes
11
Some things to read
Please read the Patient Information Sheet Part
2 for detailed information.
Please read the patient information sheet
specific to each treatment group.
Table 1 below provides an overview on all
information leaflets available for you to read.
Please make a note of any questions you might
have and talk to your doctor or research nurse
When reviewed by your research doctor or
nurse you should expect to be asked about any
new symptoms you may be experiencing and
any new medications you may have started.
We will also record your weight and waist
circumference and perform some blood tests.
As well as testing whether the research
treatments help control your prostate cancer,
we are interested in the effects of treatment on
other medical problems such as heart disease,
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Table 1
STAMPEDE: Patient Information Sheets
What Patient
Information Sheet
(PIS)?
Content
Who should read it?
When?
General PIS Part 1
Overview of why the study is being
done and what it involves
Everyone
When being approached
about the study
General PIS Part 2
Details of study conduct and
oversight
Everyone interested in
taking part
When being approached
about the study
Arm A and K PIS
Details of treatment associated
with each arm of the study
Everyone interested in
taking part
Before randomisation
and informed consent
Additional Research PIS
Details of quality of life study and
other optional studies
Everyone interested in
taking part
Before randomisation
and informed consent
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Figure 1. STAMPEDE treatment groups
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