Download stampede: patient information sheet-general

STAMPEDE: PATIENT INFORMATION SHEET-GENERAL: PART 1
(to be printed on local hospital headed paper)
Version 9.0 (October 2012)
A LARGE PRINT VERSION IS AVAILABLE ON REQUEST
STAMPEDE: Systemic Therapy in Advancing or Metastatic Prostate Cancer Evaluation of Drug Efficacy
1. General Information
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 way.
This sheet should be read with the “General Patient Information Sheet - Part 2” and
treatment specific sheets.
2. Why is this research being done?
This study is called STAMPEDE and looks at the effect of combining one or two of
these newer treatments described above with standard hormone treatment.
Prostate cancer often depends upon the male hormone testosterone to grow. One
of the main ways of treating prostate cancer involves hormonal treatment to
reduce the level of testosterone in the body. This is achieved by using a range of
drugs which reduce the signals to the testicles so they do not make the hormone,
or by surgically removing the part of the testicles that produces testosterone. Some
men may also have RT as part of their standard therapy.
Hormone treatment is usually successful at first: further growth of the cancer is
prevented and it will usually cause the cancer to shrink. However, after a period of
time the cancer can begin to grow again. Nowadays, this type of prostate cancer is
usually called castrate-refractory prostate cancer and is often abbreviated to CRPC.
There are a number of treatments that are used for prostate cancer, either early in
the disease or once it has stopped responding to standard first-line hormone
treatment. We are testing these treatments in men starting long-term hormone
treatment for the first time to see if they are more effective if used earlier on in the
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disease rather than if they are saved for use later in the disease. These treatments
are listed in Table 1 below.
In addition to studying the effect of the treatment on the growth of your cancer, we
will also be asking how it has affected your quality of life. We will also be aiming to
find out more about how prostate cancer develops and grows. We would like your
consent to carry out a small number of additional tests to help us do this. Details of
these additional studies are covered in the information sheet entitled “Additional
Research” that you will have been given.
Table 1: The research treatments currently in this study
Zoledronic acid (marketed as Zometa®)
Prostate cancer cells can spread to bones and weaken them. Zoledronic acid is a
bisphosphonate, which is currently used in men when the cancer has spread to
the bones after the cancer has stopped responding to standard hormone
treatment. Zoledronic acid reduces bone destruction and hardens the normal
bone; this may make them more resistant to attack by cancer cells.
Docetaxel (marketed as Taxotere®)
This is a chemotherapy drug that stops cells dividing and multiplying. It is
currently used to treat prostate, lung, breast and ovarian cancers. Docetaxel, in
combination with a steroid (either prednisolone or prednisone), is approved by
regulatory authorities for the treatment of castrate-refractory prostate cancer
(cancer that is no longer responsive to standard first-line hormone treatment).
Abiraterone (marketed as Zytiga®)
This is a recently licensed hormone drug treatment, taken as a daily tablet
combined with a steroid (either prednisolone or prednisone). It acts on one of
the ways that prostate cancer cells use to bypass the standard hormone
therapies. It is approved for use in men whose cancer has stopped responding to
both hormone treatment and who have also previously received docetaxel
chemotherapy.
Prostate radiotherapy for men with metastatic disease
This is a standard treatment for men with localised prostate cancer that kills
cancer cells in the prostate using high energy x-rays. It acts by stopping cells
dividing and multiplying and destroying cancer cells in the treated area.
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3. How is the research done?
The best way of determining whether one treatment is more effective than another
is by carrying out a clinical trial called a “randomised controlled trial”. These studies
aim to make a fair comparison between new treatments and the existing treatment
to see which one works best. A controlled trial compares two or more groups of
people: a research group who receive the research treatment and a control group
who receive the standard treatment. This allows researchers to see whether the
treatment they are testing is any more or less effective than the existing
treatment.
If you join the study, the decision about which group you will join is random –
based on chance. A computer programme will allocate which treatment group you
would join, not you nor your study doctor. This is called randomisation and it
ensures that the groups of people in each group of the study are as similar as
possible, except for the treatment they receive. This is important because it means
that researchers can be sure that any differences in outcomes between the groups
are caused by the treatment. “Randomisation” is also the best way of ensuring that
the results of trials are not biased by the way treatments are selected which is key
to a fair test. You should be willing to accept whichever treatment you are allocated
if you choose to join the study.
We intend to include approximately 5,000 men like you in this study (Figure 1).
They will be treated at hospitals all over the UK and internationally. We expect to
take between 6 and 10 years to complete recruitment to the study.
4. Which treatment might I receive if I take part?
All men taking part in the trial will receive hormone treatment, which is standard
treatment for your type of prostate cancer. Men with newly diagnosed disease that
has not spread elsewhere (non-metastatic prostate cancer) may also have
radiotherapy as part of the standard-of-care. This is discussed in section 5 and
your study doctor will talk to you about this. We have called the men who receive
standard hormone treatment or standard hormone therapy with standard
radiotherapy Treatment Group A.
The other groups of men will also receive the standard therapy, plus one or two of
the research treatments. We have called these Treatment Groups B, C, E, G and H.
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For your information, STAMPEDE previously included two further Treatment
Groups, D and F, but as we already have enough men to collect the necessary
information on the drug being studied in these arms, we are no longer recruiting to
those arms.
Details of the treatments are given in Table 2. From every 9 men with metastatic
prostate cancer joining the trial, 2 will be allocated the control arm (Treatment
Group A), 1 each to docetaxel, zoledronic acid and the combination arms
(Treatment Groups B, C and E), 2 to the abiraterone arm (Treatment Group G) and
2 to the research radiotherapy arm (Treatment Group H). For all other men joining
trial, from every 7 men with non-metastatic disease, 2 will be allocated the control
arm, 1 each to docetaxel, zoledronic acid and the combination arms, and 2 to the
abiraterone arm. These are broad average figures for the STAMPEDE trial at the
moment. There are separate information sheets for each treatment group that give
more details about both standard treatments and the research treatments. If you
choose to join the trial you will definitely be given the sheet for the treatment
group you are allocated at that time, but you are very welcome to read all of these
at any time, including now.
Table 2: The Research Groups in the STAMPEDE Trial
Group A. Hormone Treatment
If you are in Treatment Group A, you will receive hormone treatment only. This is
the standard treatment for patients with your type of prostate cancer. Hormone
treatment reduces the testosterone level in the body. It is sometimes called
androgen suppression or androgen deprivation therapy. Your study doctor will
discuss the different types of hormone treatment and together you can decide on
the most suitable way for you. The two approaches to hormone treatment you
can choose within the trial are:
(i) Chemically, by injections. These are usually administered once a
month or once every three months, though longer acting
preparations are becoming available
(ii) Surgically, by an operation. The functioning parts of both testicles are
removed. This called an orchidectomy and is sometimes called
bilateral orchidectomy.
Group B. Hormone Treatment and Zoledronic Acid
If you are in Treatment Group B, you will receive hormone treatment as described
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in Treatment Group A plus zoledronic acid. Zoledronic acid will be given as an
injection into a vein once every three weeks, for 6 injections, and then once every
four weeks for up to two years.
Group C. Hormone Treatment and Docetaxel
If you are in Treatment Group C, you will receive hormone treatment as described
in Treatment Group A plus docetaxel. Docetaxel will be given as an injection into
a vein once every three weeks, for a total of 6 injections. You will also be given
steroid tablets (prednisolone in the UK) to take while you are on docetaxel.
Group E. Hormone Treatment and Zoledronic Acid and Docetaxel
If you are in Treatment Group E, you will receive hormone treatment as described
in Treatment Group A plus both zoledronic acid and docetaxel. Zoledronic acid and
docetaxel will be given as separate injections into a vein once every three weeks
for the first 6 injections. Then only zoledronic acid will continue to be given, once
every four weeks, for up to two years. You will also be given steroid tablets to
take while you are on docetaxel.
Group G. Hormone Treatment and Abiraterone
If you are in Treatment Group G, you will receive hormone treatment, as
described in Treatment Group A plus Abiraterone. Abiraterone will be given as a
daily dose. of 1g (four tablets) for up to 2 years. The tablets need to be taken on
an empty stomach. In addition, you will need to take either prednisolone or
prednisone (which are steroid tablets) daily while you are on abiraterone.
Group H. Hormone treatment and prostate radiotherapy for men with
metastatic disease
If you are in Treatment Group H, you will receive hormone treatment as described
in Treatment Group A plus radiotherapy to the prostate. The radiotherapy would
require a visit to a CT scanner for radiotherapy planning soon after joining the
trial. Treatment would commence a few weeks later and would comprise sessions
of about 10 minutes. These sessions will either be once a week for 6 weeks, or 5
times a week for 4 weeks.
The possible study treatment that you could receive differs slightly, depending on
your situation.
If you have newly diagnosed metastatic disease, you could be
allocated to any of the study treatments.
If not, you will not be randomised to
Treatment Group H (see Figure 3).
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Figure 3: Treatment groups in the study
Patients eligible for STAMPEDE
NEWLY DIAGNOSED M1 PATIENTS1
ALL OTHER PATIENTS2
RANDOMISATION
RANDOMISATION
A
ADT
A
ADT
B
ADT + zoledronic acid
B
ADT + zoledronic acid
C
ADT + docetaxel
C
ADT + docetaxel
E
ADT + ZA + docetaxel
E
ADT + ZA + docetaxel
G
ADT + abiraterone
G
ADT + abiraterone
H
ADT + RT to prostate
1 except
2 all
pts with a contra-indication to RT
suitable pts with newly diagnosed locally advanced disease should also have RT1
5. Can I also receive standard-of-care radiotherapy?
Recent controlled trials like this one have shown us that there are some groups of
men who we know should receive radiotherapy as part of their standard care.
(i) If you have disease that is confined to the prostate, we recommend that
radiotherapy be given unless there are specific reasons not to give it (for
example, certain bowel problems). The trial includes recommended
guidelines for giving radiotherapy but these can be modified to fit local
practice in your hospital.
(ii) If your disease is confined to the prostate gland and lymph glands nearby in
the pelvis, we also recommend that radiotherapy be included as part of
your standard care, if your doctor thinks it is feasible in your case.
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If you have newly-diagnosed metastatic disease, radiotherapy to the prostate is not
part of standard care. Therefore, we are testing whether this would be helpful in
the men allocated to Treatment Group H. Figure 3 shows which treatment groups
you might be allocated to.
If given, standard radiotherapy should start around 6 months after starting
hormone treatment and, for men in Research Groups C and E, after chemotherapy
has finished, since receiving radiotherapy and chemotherapy at the same time can
cause additional unwanted side-effects. During and after the radiotherapy you
would continue with hormone treatment. Treatment would typically take between
20 and 37 sessions according to local practice. Further detailed information will be
given by your cancer doctor.
6. What are the unwanted side-effects?
All men joining the study will be given hormone therapy which is standard
treatment. It works by reducing the level of testosterone in the body. The
unwanted side-effects associated with the reduction of testosterone levels might
include: impotence, decreased sex drive (loss of libido), hot flushes and,
occasionally, a small amount of swelling of breast tissue.
Long-term hormone treatment based on reduction of testosterone in the body can
reduce bone density in some men, leading to an increased risk of osteoporosis
(bone thinning). In most men, this does not lead to any clinical symptoms. There is
no generally agreed way of dealing with this potential problem.
Table 4 outlines the most common unwanted side-effects that can occur with the
newer treatments. More details on the potential unwanted side-effects from the
research treatments are given in the arm-specific Patient Information Sheets.
You will be given the treatment specific PIS after you are randomised, but you are
very welcome to read them all now. Just ask your study doctor.
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Table 4: Possible unwanted side-effects from the research treatments
Zoledronic acid
Flu-like symptoms, e.g. raised temperature and body aches. Uncommonly,
zoledronic acid can cause breakdown (osteonecrosis) of the jaw. This is
associated with long-term use of zoledronic acid (usually over 36 months),
particularly in patients who have dental disease. Zoledronic acid should be
discontinued if you need a tooth extraction.
Docetaxel
Hair loss, allergic reactions, fluid retention, sickness, anaemia. Also it may lower
the level of other blood cells making you more susceptible to bruising, bleeding
and infections.
Abiraterone
Tiredness, raised blood pressure, fluid retention and low potassium levels in the
blood which therefore need regular monitoring).
Prostate radiotherapy for men with metastatic disease
Frequent or urgent bowel movements, rectal bleeding, increased urinary
frequency.
More information is given in the treatment specific information sheets.
7. Do I have to take part in the study?
Your participation in the STAMPEDE study 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 way. The standard treatment for your type of
prostate cancer is hormone treatment. All men taking part in the trial will receive a
form of hormone treatment as well as radiotherapy, if appropriate. If you agree to
take part you are free to stop the trial treatment without giving your reasons and
without affecting your future care.
8. What will happen to me if I take part in the study?
Whether you receive your treatment in hospital or at home will depend on the
treatment group you are in. If you are to receive docetaxel, it will be given to you
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in a specialised ward or unit: <insert where this would be>. If you are to receive
zoledronic acid you will also need to make extra visits to your hospital for
treatment: <insert where this would be>. If you are to receive abiraterone, the
tablets will be taken daily at home but you will need some extra blood tests,
particularly in the first few weeks, to be sure there aren’t any problems. If you are
to receive prostate radiotherapy, you will need to visit the hospital for up to 20
treatment sessions.
If you agree to take part in the trial, there will be some additional blood tests to
measure the progress of your cancer (approximately 6 in the first 2 years). If you
are to receive zoledronic acid, docetaxel or abiraterone (Treatment Groups B, C, E
or G) there will be some more blood tests to monitor the safety of your treatment.
Your study doctor will see you at least every 3 months for 3 years, then at least
every 6 months as part of this trial.
9. What are the possible advantages of taking part in the study?
There are a number of treatments that have proved effective in the treatment of
prostate cancer that has stopped responding to hormone treatment, as described
above. We don’t know whether using these treatments earlier in the disease and in
combination with standard hormone treatment will be better than hormone
treatment alone. Therefore, your participation may not be of direct benefit to you.
Your participation will, however, help to answer these questions and help us to
improve treatment for men like you in the future.
10. What are the possible disadvantages?
In this trial you may be asked to take additional treatment(s) as well as the
hormone treatment. We do not expect there to be any disadvantage to you in
terms of how your cancer responds but the additional treatments may have some
additional side-effects (Table 2). 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.
End of PIS Part 1
Please read PIS Part 2 for detailed information
Please read treatment specific PISs as relevant
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