Download PIS Treatment Part 3 Arm K v1.0 Mar-2016 - clean

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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 K in STAMPEDE.
You will receive standard hormone
treatment as well as metformin.
Your doctor will also discuss whether
your standard treatment will include
chemotherapy.
Please take your time reading this
information. Discuss it with friends and
relatives if you wish.
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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This sheet should be read with the
General Patient Information Sheet Part
1 and General Patient Information
Sheet Part 2
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In this information sheet, the term
“study” and “clinical trial” will be used
interchangeably and they are intended
to mean the same thing.
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Contents
1 Why is metformin being tested as a
treatment for prostate cancer?
2 Will my standard treatment change?
3 How is metformin given?
4 What if I miss a dose?
5 What are the possible side effects?
6 How long will I be on treatment for?
7 Situations when I should pause
metformin
8 Will metformin interact with other
medications?
9 What to do if I feel unwell
10 Where can I find out more?
11 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
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1
Why is metformin being
tested as a treatment for
prostate cancer?
Metformin is a tablet treatment
currently used in the management of
Type 2 diabetes.
Metformin affects the metabolism of
sugars and fats. It is thought that
metformin may prevent some of the
metabolic effects of hormone
treatment. These include weight gain
and insulin resistance which may lead to
diabetes and increase the risk of heart
disease. Studies have also shown that
metformin may prevent prostate cancer
growth and progression.
We are testing whether adding
metformin to the current standard
treatment enables men to live longer.
We will also assess the effects on
weight, glucose control and whether it
prevents the development of diabetes
and heart disease.
2
Will my standard treatment
change?
No. As detailed in the patient
Information Sheet Part 1, your doctor
will discuss which standard treatments
are recommended for you. All research
treatments are given in addition to
standard treatments which remain
unaffected if you take part in
STAMPEDE.
Standard treatment will always include
a type of hormone treatment. Prostate
cancers need the male testosterone to
grow. Hormone treatments work by
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stopping testosterone from reaching
prostate cancer cells. They can help to
control the growth of the cancer
wherever it is in the body.
All men joining the study will be starting
long-term hormone treatment
(treatment lasting for at least 2 years).
If you have advanced prostate cancer
that has spread to other parts of the
body (metastatic prostate cancer)
hormone treatment is continued lifelong.
If you have localised prostate cancer
(confined to the prostate and nearby
lymph nodes) you will remain on
hormone treatment for a minimum of 2
years.
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 nearby lymph glands in the
pelvis
Your clinical oncologist (radiotherapy
doctor) will discuss whether this is
suitable for you.
Recent results from STAMPEDE and
another clinical 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 studies, men who
received chemotherapy live longer. You
and your doctor should have discussed
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if chemotherapy is recommended for
you.
3
How is metformin given?
Metformin is a tablet treatment. The
starting dose is one 850mg tablet taken
once a day with or after food. After 4
weeks of treatment and having
reviewed any side effects, your research
team will discuss increasing the dose to
850mg twice a day. You should aim to
take your tablets at the same time each
day, a minimum of 8 hours apart, for
example with or after breakfast and
your evening meal.
You will always receive your
prescription for metformin from your
oncology research team.
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What are the possible side
effects of metformin?
What if I miss a dose?
It is very important that you tell your
research doctor or nurse if you miss any
doses or take the wrong number of
tablets. If you forget to take your
metformin tablets 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. Please try and make a note of any
doses that you miss as your research
team will ask you this at each clinic visit.
It is helpful if you record the dates of
any treatment pauses.
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Metformin can cause mild abdominal
cramps and diarrhoea. Some people
also notice a change in appetite and
taste and feel sick. Taking your
metformin with or after food can help
reduce these side effects. Please tell
your research nurse or doctor if this
continues to be a problem as changing
the type of tablet or reducing the dose
may help.
6
How long will I be on
treatment for?
How long you remain on treatment with
metformin depends on the stage of your
prostate cancer when you join the
study.
If your prostate cancer has spread to
other the body (metastatic prostate
cancer) you should remain on
metformin life-long providing you are
able and willing to take it.
If you have localised prostate cancer
you should continue to take metformin
for a minimum of 3 years after you join
the study and whilst you are receiving
long-term standard hormone treatment
(whichever is longer). If your standard
hormone treatment stops you should
continue metformin for a further 12
months after your last LHRH injection or
implant was given to allow sufficient
time for your testosterone level to
return to normal. If hormone treatment
is re-started whilst you remain on
metformin (i.e. within 12 months of
stopping) then metformin should
continue whilst you are on standard
hormone treatment.
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You can also choose to stop metformin
at any point should you wish but please
discuss this more with your research
nurse or doctor so they are aware and
know why. You will require monitoring
with blood tests every 3-6 months
whilst on metformin to confirm that it is
safe for you to continue.
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Important situations when
metformin needs to be
paused
Always make sure your doctors, nurses
and pharmacist are aware that you are
taking metformin. There are some
circumstances where you should pause
metformin. These include:
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CT scans with contrast: stop
metformin the day before the scan
and re-start 2 days afterwards.
Surgery or procedures requiring a
general anaesthetic: stop treatment
the day before and re-start 2 days
afterwards providing you are eating
and drinking normally
Severe diarrhoea, vomiting or
unable to eat and drink: stop
metformin and seek medical advice.
Only re-start once eating and
drinking normally.
8
Will metformin interact with
my other medications?
Metformin can be safely taken with all
other treatments for prostate cancer.
You should tell your research team
about all your current medications to
check for any interactions. You should
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always tell your doctor or pharmacist
that you are taking metformin especially
when starting tablets to treat high blood
pressure. Non-steroidal pain killers such
as ibuprofen should be avoided if
possible.
9
What do I do if I feel
unwell?
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.
Please update your research team if you
attend your GP or hospital for problems
relating to your prostate cancer.
10
Some things to read
This information sheet should be read
together with General Patient
Information Sheet- Part 1 and General
Patient Information Sheet- Part 2 for
detailed information.
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.
11
Further information
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If you want further information about
the STAMPEDE study, contact your
study doctor or nurse (see below).
[Insert address and telephone number
of study doctor and/or nurse]
Useful contacts and where to find out
more:
www.macmillian.org.uk
www.prostatecanceruk.org/prostateinformation
More information is also available on
our website www.stampedetrial.org.
Thank you for taking the time to
consider taking part in this study
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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, H 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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