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STAMPEDE Trial
We are inviting you to take part in a
research study called STAMPEDE
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This information leaflet is for men who
have been allocated to Treatment
Group J in STAMPEDE.
You will receive standard hormone
treatment as well as the new
combination of enzalutamide and
abiraterone.
Your doctor will also discuss whether
your standard treatment will include
radiotherapy or chemotherapy. We
have included some information about
each of these treatments in case this is
relevant to you.
Please take your time reading this
information.
Make a note of any questions you might
have and discuss them with your doctor
or nurse.
Please always tell your doctor or nurse
of any side-effects you experience on
treatment to make sure you get support
in managing these.
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6 Information on chemotherapy
7 Abiraterone acetate
8 Enzalutamide
9 How long will I be on treatment for?
10 Will this treatment interact with my
current medications?
11 What if I feel unwell on treatment?
12 Contacts for further information
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: 01234 XXX XXX
Contents
1 What treatment will I receive?
2 What are the different types of hormone
treatment
3 What are the benefits of hormone
treatment
4 What are the possible side-effects of
hormone treatment
5 Information about radiotherapy
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1
What treatment will I
receive?
All men in Treatment Group J receive
standard treatment as well as the
research treatment (enzalutamide and
abiraterone)
Standard treatment will always include
a type of hormone treatment. Prostate
cancers need the male testosterone to
grow. Hormone treatments work by
stopping testosterone from reaching
prostate cancer cells. They can help to
control the growth of the cancer
wherever it is in the body. If you have
advanced prostate cancer that has
spread to other parts of the body
(metastatic prostate cancer) hormone
treatment after around 2 years,
providing your PSA has fallen and stays
low.
After discussing with their doctor some
men may choose to have breaks from
their hormone treatment, referred as
intermittent hormone treatment. This is
not suitable for all men and we would
recommend that you and your doctor
consider it only after you have had at
least 2 years of hormone treatment.
Research has shown us that men with
localised prostate cancer benefit from
radiotherapy. Because of this, it is now
recommended as part of standard
treatment if:
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Your cancer remains within the
prostate
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Your cancer is within the
prostate and lymph glands
nearby the pelvis
Your clinical oncologist (radiotherapy
doctor) will discuss whether this is
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suitable for you. There are some other
medical conditions such as bowel
problems that mean this might not be
offered to you.
Recent results from this and another
American trial (called CHAARTED) have
shown that, in men starting hormonal
treatment for the first time, adding
chemotherapy to standard treatment
controls prostate cancer for longer and,
in both trials, men who received
chemotherapy live longer. You and your
doctor should have discussed if
chemotherapy is recommended for you.
If you are receiving or going to receive
chemotherapy then more information is
provided in Section 6.
2
What are the different types of
hormone treatment?
There are different types of hormone
treatment 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.
Anti-hormone injections
There are two types of anti-hormone
injections known as LHRH analogues
and LHRH antagonists. These work in
slightly different ways but both stop the
testicles making hormone testosterone.
Depending on the type of injection, they
are given around once every month or
once every three months, usually into
the skin of the abdomen or into the
arm.
Before you have your first injection, you
may receive a short course of antiandrogen tablets. This is to stop a
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“disease flare” which can be caused by
your bodies’ response to the first
injection which is to make more
testosterone; this can make symptoms
worse for a short time. These tablets
can be safely stopped around 2 weeks
after your first injection.
Surgery to remove the testicles
(orchidectomy)
In men who require long term hormone
treatment. An operation can be done to
remove the testicles or parts of the
testicles that make testosterone. This is
used less often but is an alternative to
regular injections. If you and your
doctor decide this is the best option for
you, a surgeon will discuss the details of
the operation with you. Short term side
effects can include pain, swelling and
bruising of the scrotum that will get
better after a couple of weeks. As with
any surgical operation an infection can
occur in the wound.
3
What are the benefits of
hormone treatment?
Hormone treatment is effective at
shrinking prostate cancer and slowing
down its growth. It can be used to treat
prostate cancer wherever it has spread
to in the body. It can also help reduce
symptoms of prostate cancer such as
difficult passing urine and pain. In
metastatic prostate cancer all other
treatments are used alongside hormone
treatment. You should always discuss
with your doctor before stopping your
hormone treatment as it may make
other treatments less effective.
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4
What are the possible sideeffects of hormone treatment?
When first starting hormone treatment
given as an injection, some men
experience a mild allergic reaction to
the injection. Occasionally, you might
also get headaches and mild aches and
pains to begin with due to the change in
your testosterone levels.
All types of hormone treatment reduce
testosterone levels which can cause
side-effects. These can include hot
flushes, impotence, loss of libido (sexual
drive) and occasionally mild breast
swelling and tenderness, and absentmindedness. In addition, if you receive
hormone treatment over a long period
of time it can cause bone thinning (in
severe cases this is called osteoporosis).
You may also notice you gain weight
and lose muscle strength. There may
also be an increased risk of developing
diabetes and heart disease. Hormone
treatment affects different people in
different ways. If you experience sideeffects, please discuss these with your
doctor or nurse to make sure you get
support in managing these.
5
Information about
radiotherapy
If you have localised prostate cancer
(cancer confined to the prostate and
nearby lymph nodes in the pelvis), your
doctor will discuss whether you should
have radiotherapy. If you have
radiotherapy, it should start around 6 to
9 months you start hormone treatment.
Before you start, you will need a CT scan
to plan your treatment which will
usually start a few weeks later. You will
need to visit the hospital very often
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whilst you receive your treatment which
is given over several weeks (usually 4 to
7 weeks).
Radiotherapy can cause side effects
which usually last a few weeks or
months, but some can last longer.
Radiotherapy to the prostate can irritate
the nearby bladder and bowel. This can
cause urinary urgency and sometimes
blood in the urine. You may notice your
bowel habit changes. You might also get
erection problems. It is common to feel
tired whilst receiving treatment. Your
radiotherapy team will discuss the
details of your treatment with you
more. Please tell your doctor or nurse if
you get side effects to make sure you
get support in managing these.
6
Information about
chemotherapy
If you and your doctor decide to use
chemotherapy, it should start within 12
weeks from starting your hormone
treatment.
The type of chemotherapy is called
docetaxel. You will need to visit the
chemotherapy day unit at your hospital
for each treatment which will be given
as drip (an infusion into a vein); this
takes around one hour. Docetaxel is
given every three weeks and you will
usually receive 6 treatments in total.
You may get side-effects with docetaxel.
You are likely to feel tired and you may
feel sick in the days after your
treatment. You usually lose your hair
and you may notice nail changes. You
may retain extra fluid and notice your
ankles swell. Sometimes the nerves of
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the hands and feet are affected causing
numbness or tingling, please let your
doctor know if this happens. Docetaxel
can reduce the number of white blood
cells, weakening your immune system
putting you at risk of getting an
infection which can be very serious. It is
very important that you check your
temperature if you feel unwell and seek
immediate advice if you have a fever
(temperature ≥ 38 degrees). Please tell
your doctor or nurse about any sideeffects you experience as there are
often supportive treatments that can
help.
7
Abiraterone acetate
What do we know about
abiraterone already?
Hormone treatments like LHRH agonists
(eg. Zoladex®) work by stopping the
testicles from making testosterone. One
way prostate cancer cells can stop
responding to is this type of treatment
by making their own supply of
testosterone instead. Abiraterone is a
treatment that works by blocking the
production of testosterone.
Abiraterone has been tested in clinical
trial of men with advanced prostate and
has been shown to work after hormone
treatments have stopped working. In
the clinical trials men treated with
abiraterone lived longer and without
many severe side effects. Abiraterone is
now used in metastatic prostate cancer,
after hormone treatment has stopped
working (castrate resistant prostate
cancer).
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How and when do I take
abiraterone and prednisolone?
What are the possible side-effects
of prednisolone?
Abiraterone is taken once a day by
mouth. You will need to take four
250mg tablets. Food can interfere with
the absorption of abiraterone so you
need to have an empty stomach i.e.
around 2 hours after eating. You should
not eat again for around 1 hour after
taking the abiraterone.
You will be given a low dose of steroid
(prednisolone 5mg) as well as
abiraterone to reduce the chance that
you will get side-effects from
abiraterone. Unfortunately steroids can
cause some side-effects of their own.
These can include fluid build-up causing
ankle swelling and high blood sugar
levels (especially in people with
diabetes) and high blood pressure.
Other side-effects can include mood
changes including depression, anxiety or
difficult sleeping. You may notice your
skin thin or bruise more easily. If used
for some time steroids can cause weight
gain and thinning of bones (of severe
this is called osteoporosis) and eye
problems such as cataracts or glaucoma.
Abiraterone prescribed with a steroid
(prednisolone 5mg daily) to reduce the
risk of side-effects.
What are the possible side-effects
of abiraterone?
Abiraterone can cause some side
effects. These may include feeling tired
and noticing hot flushes becoming more
of a problem. Some medical problems
can be made worse by abiraterone and
it is important that you talk with your
doctor if you are affected by any of
these conditions before you start
treatment. Abiraterone can cause high
blood pressure and heart problems,
including an irregular heart beat and
worsening of angina (chest pain) or
heart failure. Abiraterone can also cause
a build-up of fluid causing ankle
swelling, low potassium levels and
anaemia. The liver can be affected by
abiraterone and you will need regular
blood tests to monitor this. You may
notice a change in your bowel habit and
feeling sick or less hungry are both
common side effects.
Women who are pregnant or who may
be pregnant should wear gloves if they
need to touch abiraterone acetate
tablets. You should make sure any cares
or family members know this before
handling your tablets.
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It is important that you do not stop
steroids suddenly. Always discuss this
with your doctor first as you will likely
need to reduce the dose slowly.
8
Enzalutamide
What do we know about
enzalutamide already?
Enzalutamide is an androgen receptor
inhibitor. It works by blocking the
action of the male hormone
testosterone and other male hormones
known as androgens, and slowing down
the growth of the prostate cancer.
Enzalutamide is approved for use in
men with advanced metastatic prostate
cancer after hormone therapy has
stopped working (castration-resistant
prostate cancer). Several clinical trials
are testing whether enzalutamide can
benefit men with earlier stage prostate
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cancer including STAMPEDE which is
testing it in combination with
abiraterone.
How and when do I take
enzalutamide?
Four 40mg capsules of enzalutamide
(160 mg) should be taken by mouth
once a day, with or without food.
What are the possible side-effects
of enzalutamide?
Enzalutamide can cause some side
effects. These include tiredness,
worsening hot flushes and high blood
pressure. You may notice that your
bowel habit changes; you may feel sick,
less hungry and experience abdominal
pain. Occasionally men experience
breast swelling and tenderness.
Headaches are also more common. In
clinical trials men treated with
enzalutamide were slightly more likely
to have a seizure; for this reason we do
not recommend anyone joins the trial
who has had a previous seizure or head
injury.
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How long will I be on
treatment for?
This depends on how far your prostate
cancer has spread. If your prostate
cancer has spread to other the body
(metastatic prostate cancer) you will be
on hormone treatment life-long.
Enzalutamide and abiraterone will also
be continued for as long as your cancer
is controlled. If the cancer begins to
grow, enzalutamide and abiraterone will
be stopped and your doctor will discuss
alternative treatment with you.
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If your cancer is confined to the
prostate and nearby lymph nodes in the
pelvis (locally advanced prostate cancer)
and you are receiving radiotherapy as
part of your treatment then you will be
given enzalutamide and abiraterone for
a maximum of 2 years. Your treatment
may stop sooner than that if your
cancer begins to grow.
You can also choose to stop
enzalutamide and abiraterone at any
point should you wish; your doctor may
also recommend you stop if you
develop severe side-effects.
What if I miss a dose?
It is very important that you tell the
study staff if you miss any doses or take
the wrong number of capsules/tablets.
If you forget to take your drugs at the
regular time, you can take them as soon
as you remember that day. However, if
you forget to take your drugs for the
whole day, just take your normal doses
at your regular time the next day. Do
not try to make up for a missed dose by
taking a double dose or extra dose on
the next day. If you forget or are unable
to take your prednisolone, you should
contact your doctor immediately as
steroids should not be stopped
suddenly.
10
Will this treatment interact
with my current medications?
Both enzalutamide and abiraterone can
interact with some medicines. This can
mean enzalutamide and abiraterone are
maybe less effective and can increase
the risk of severe side effects. Both
treatments can also interact with other
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drugs and make them less likely to work
or cause more severe side effects.
that you are taking your trial medication
(including the steroid, prednisolone)
It is very important to tell your doctor
about all the medicines you take,
including prescription and nonprescription medicines, vitamins, and
herbal supplements and including any
new medicines you need to take. You
need to know all the medicines you
take. Keep a list of them with you to
show your study doctor and pharmacist.
You should not start or stop taking any
medicine before you talk with the study
doctor.
Useful contacts and where to find out
more:
Be sure to tell your study doctor if you
are taking:
[Insert address and telephone number
of study doctor and/or nurse]
www.macmillian.org.uk
www.prostatecanceruk.org/prostateinformation
12
Contacts for further
information
If you want further information about
the STAMPEDE study, contact your
study doctor or nurse (see below).
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Anti-coagulation e.g. Warfarin,
dabigatran
More information is also available on
our website www.stampedetrial.org.
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Drugs for heart disease or high
blood pressure e.g. metoprolol,
flecanide, nifedipine, ivabradine
Thank you for taking the time to
consider taking part in this study.
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Pain killers e.g. tramadol,
codeine, fentanyl or oxycodone
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Anti-depressants including St
Johns Wart
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Treatment for gout e.g.
colchicine
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What if I feel unwell on
treatment?
Please always tell your doctor or nurse
about any new symptoms you
experience whilst on treatment. If you
become unwell between hospital visits,
please seek advice immediately, either
from your hospital or from your GP.
Always tell your treating medical team
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