Download PIS Treatment Part 3 Arm H v11.0 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 provides
more information on Treatment
Group H in STAMPEDE.
These men are going to receive
radiotherapy in addition to
standard treatment.
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
This sheet should be read with the
General Patient Information Sheet
Part 1 and General Patient
Information Sheet Part 2
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 STAMPEDE assessing
radiotherapy to the prostate?
2 Will my standard treatment change?
3 What are the possible side-effects of
radiotherapy
4 What to do I feel unwell during
treatment
5 Some things to read
6 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: XXXXX XXX XXX
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1
Why is STAMPEDE assessing
radiotherapy to the
prostate?
We know that radiotherapy to the
prostate benefits men with localised or
locally advanced prostate cancer, this
means the cancer is confined to the
prostate or nearby lymph nodes in the
pelvis and has not spread to other parts
of the body. Clinical trials have shown
that men with localised or locally
advanced disease who have
radiotherapy to the prostate live longer.
It is not yet known whether men whose
cancer has already spread to other parts
of the body (metastatic prostate cancer)
also benefit from prostate radiotherapy
and STAMPEDE will hopefully help
answer this question.
You will receive radiotherapy to the
prostate and your radiotherapy doctor
will be able to give you more details
about your treatment plan. A week or
two before the treatment can start you
will need a planning scan (usually a CT
scan) to map the area that will be
treated.
Two different treatment schedules are
being tested in the trial and your
radiotherapy doctor will choose which is
more appropriate for you. Depending
on your schedule you will need to visit
hospital for treatment either once a
week for 6 weeks or 5 times a week for
four weeks. It takes around 10 minutes
for the treatment to be given but often
extra time is needed to get you in the
right position.
2
Will my standard treatment
change?
No. As detailed in General Patient
The theory is that giving radiotherapy to
Information Sheet Part 1, your doctor
the prostate will slow the growth of the
will discuss which standard treatments
cancer elsewhere in the body (the
are recommended for you. All research
metastases). This has been shown to be
treatments are given in addition to
the case in other types of cancer.
standard treatments which remain
Results from clinical trials have shown
unaffected if you take part in
that giving radiotherapy to the primary
STAMPEDE.
tumour (where the cancer originally
started) slows the growth of distant
metastasis in both breast and kidney
Standard treatment will always include
cancer. This supports a long standing
a type of hormone treatment. Prostate
theory known as the “seed and soil”
cancers need the male testosterone to
hypothesis where an active primary
grow. Hormone treatments work by
tumour feeds the metastases by
stopping testosterone from reaching
providing the “seeds” of tumour that
prostate cancer cells. They can help to
could grow and preparing the
control the growth of the cancer
environment in which could grow (the
wherever it is in the body.
“soil”). Therefore treating the prostate
(site of the primary tumour) may
control the disease that has spread to
other parts of the body (metastases).
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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.
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
if chemotherapy is recommended for
you.
3
What are the possible
side-effects of
radiotherapy?
Radiotherapy has been used to manage
prostate cancer for many years and it is
a standard treatment for men with
localised or locally advanced prostate
cancer. Like all treatments, radiotherapy
can cause side effects which usually last
a few weeks or months, but some can
last longer.
It is common to feel tired whilst
receiving treatment. You might also get
erection problems which are common
with both hormone treatment and
prostate radiotherapy. Radiotherapy to
the prostate can irritate the nearby
bladder and bowel. In the short-term
this can cause urinary urgency and
sometimes blood or pain when passing
urine. You may also have problems with
control (urinary incontinence) during
and after radiotherapy. You may notice
your bowel habit changes, you might
get diarrhoea, urgency and occasionally
pain. You might also notice bleeding or
mucus or pus like discharge from the
back passage. Most urinary and bowel
symptoms settle a few weeks after
treatment finishes but some may last
longer. Longer term effects of
radiotherapy to the prostate can include
scarring of the urethra (the tube that
the urinary leaves the bladder through)
causing a narrowing (a stricture) or
blockage.
Your radiotherapy team will discuss the
details of your treatment with you
more. Please tell your doctor or nurse if
you get any side effects to make sure
you get support in managing these. You
will be monitored closely whilst you
receive radiotherapy. If you develop
side effects that are difficult to manage
or you wish to stop for another reason
you can. Radiotherapy will also stop if
your cancer starts to grow and your
doctor will discuss alternative treatment
with you.
4
What to do if I feel unwell
on treatment?
Please always tell your doctor, nurse or
radiographer 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.
Useful contacts and where to find out
more:
www.macmillian.org.uk
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www.prostatecanceruk.org/prostateinformation
5
Some things to read
This information sheet should be read
together with the General Patient
Information Sheet Part 1 and General
Patient Information Sheet Part 2 for
detailed information.
6
Further information
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]
More information is also available on
our website www.stampedetrial.org.
Thank you for taking the time to
consider taking part in this study.
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.
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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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