Download General part 1 - STAMPEDE trial

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paper
STAMPEDE TRIAL
We are inviting you to take part in a clinical
trial called STAMPEDE
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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 clinical trial. 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.
Important things that you need to know
To be presented on local headed
way. This sheet should be read with the
“General Patient Information Sheet Part 2” and treatment specific sheets.
Contents
1 Why are we doing this clinical trial?
2 How is the research done?
3 What do I need to know about the
treatments used in this study?
4 Can I also receive chemotherapy
(docetaxel)?
5 What are the possible side-effects?
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 More information about taking part
10 Some things to read
How to contact us
If you have any questions about this
clinical trial, please talk to your doctor
or nurse:
Name of doctor or nurse
Hospital Department
Your doctor has explained to you that you have
prostate cancer and has invited you to participate in
this clinical trial. Before you decide, it is important for
you to understand why the research is being done
and what it will involve. Participation is entirely
voluntary. If you decide not to take part, your
decision will be accepted without question, and your
subsequent treatment will not be affected in any
V13.0 PIS General Part 1
Hospital
Address
Address
Tel: 01234 XXX XXX
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 newly-diagnosed
metastatic prostate cancer involves hormone
treatment and may also include chemotherapy.
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 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 current treatment of prostate
cancer and enable men to live longer and enjoy a
better quality of life.
In the past hormone treatments were the only way
in which we could control prostate cancer. The
majority of men will respond to hormone
treatment and this is usually successful at first, but
with time the cancer cells become resistant and
start growing again. This is referred to as castrate
refractory prostate cancer (CRPC). There are a
growing number of treatments used in prostate
V13.0 PIS General Part 1
cancer. These can either be used early in the
disease or later once it has stopped responding to
hormone treatment. We are testing whether men
benefit more if these treatments are used earlier.
In the study we will collect information on how
well the different treatments control your cancer
and how your quality of life is affected. We will
also aim to find out more about how prostate
cancer grows and becomes resistant to treatment.
We would like your consent to carry out a small
number of additional tests to help us do this. For
more information on this please read the
information sheet entitled “Additional Research”.
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 trials
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.
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.
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.
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 chemotherapy
(see Section 4).
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 Group A (the control group).
All research treatments are given in addition to
standard treatment. There is currently only 1
research group open that men may join, this is
named treatment groups H.
Men joining Treatment Group H will receive
radiotherapy to the prostate For more information
on this treatment please read the treatment
specific information sheet for Treatment Group H.
For your information, this study previously looked
at other treatments (groups B, C, D, E, F, G and J).
It is no longer possible to join these groups as we
already have enough men to test these treatments.
Results for Treatment Groups a
A, 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. Results for
Treatment Groups D and F were presented at an
international conference in January 2016; a
summary will be in the website soon.
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Details of the Treatment Groups are given in the
treatment specific PIS (Treatment Group A, and
Treatment Group H PIS).
Which Treatment Group you join depends on how
your prostate cancer has developed and how far it
has spread. There is currently just one possibility:
If your cancer has spread to other parts of the
body (metastases) it is called metastatic prostate
cancer. If you had metastases when you were first
diagnosed you can be randomly allocated to any
treatment group. For every 2 men joining the study
1 will be allocated to Treatment Group A (the
control group), and 1 to Treatment Group H.
There are separate information sheets for each
Treatment Group which you will be given if you
chose to join the study and once you have been
allocated to a Treatment Group. You might also
want to read them now, if so please ask your
doctor or research nurse.
4
Can I receive chemotherapy
(docetaxel) as my standard
treatment?
Recent results from this and another American
study (CHAARTED) have shown that, in men
starting hormonal therapy for the first time, adding
chemotherapy to standard treatment 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.
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.
If you and your doctor decide to use chemotherapy
it should start no more than 12 weeks after you
start hormone treatment. Docetaxel will be given
as an injection into a vein once every three weeks,
for a total of six injections. Your doctor or nurse
will give you more detailed information about
docetaxel if this is to be part of your standard
treatment.
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What are the possible side-effects?
All standard treatments used in prostate cancer
may cause side effects.
Hormone treatments work by lowering
testosterone levels. This may cause hot flushes,
decreased sex drive (loss of libido), and
occasionally a small amount of breast tissue
swelling. If you receive hormone treatment over a
long period of time it can cause a weakening of
your bones (in severe cases this is called
osteoporosis). You may also notice you gain weight
and lose muscle. There may also be an increased
risk of developing diabetes and heart disease.
If you and your doctor decide to include
chemotherapy as part of your standard treatment
you will receive further information about the
possible side effects of this treatment.
The possible side effects of the research
radiotherapy (Treatment Group H) are included in
the specific patient information sheet. Please ask
your doctor or research nurse if you would like to
read this now.
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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 know that radiotherapy to the prostate helps
control disease that has not spread beyond the
prostate and surrounding lymph nodes. We do not
know whether it helps men with prostate cancer
that has spread to affect other areas of the body
(metastatic disease).
Although by taking part in the study you may not
directly benefit, it will help to answer this
questions and hopefully improve treatment for
men like you in the future.
8
Where are the possible
disadvantages of taking part?
In this study you may receive extra treatment(s) in
addition to standard treatment. We hope that the
treatment you receive will help control your
prostate cancer however this is not certain. The
additional treatments may have some additional
side-effects
There will also be some extra hospital visits and
blood tests, as described above. If you want to
know more, please read the next section.
9
More information about taking
part
If you are to receive research radiotherapy
(Treatment Group H) you will need to visit hospital
very often whilst you receive your treatment.
Radiotherapy can cause side effects and you
should discuss this more with your radiotherapy
team.
If you decide you would like to take part in the
study there will be some additional blood tests to
measure the progress of your cancer (we would
expect there to be about 6 in the first 2 years).
Figure 1. STAMPEDE treatment groups
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Whichever Treatment Group you join, your doctor
will see you at least every 3 months for the next 2
years, then after that at least every 6 months in
order to assess your progress whilst on the study.
10
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.
Please make a note of any questions you might
have and talk to your doctor or research nurse.