Download stampede: patient information sheet-general

STAMPEDE: PATIENT INFORMATION SHEET-GENERAL: PART 1
(to be printed on local hospital headed paper)
Version 11.0 (January 2014)
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 newer
treatments 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 radiotherapy 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 referred to as hormone-refractory or, increasingly, as castrate-refractory
prostate cancer and is often abbreviated to CRPC. This latter term is unpopular with
patient groups due to its perceived negative overtones and hence the terminology
may yet change again in the future.
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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
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 being tested in this study
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.
Enzalutamide (marketed as Xtandi®)
This is a recently licenced drug treatment with potent anti-androgens action
(androgens are male hormones); it works by blocking the action of the male
hormone known as androgens, slowing down the growth of the prostate cancer.
Enzalutamide is already approved for men with later stages of metastatic
prostate cancer who have 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. This is key
to a fair test. You must be willing to accept whichever treatment you are allocated
if you choose to join the study.
We expect to include over around 7,000 men like you in this study. 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 H and J.
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For your information, STAMPEDE previously included recruitment to five other
Treatment Groups, B, C, D, E, F and G but as we already have enough men to
collect the necessary information on the drugs being studied we are no longer
recruiting to those arms. The results of these comparisons will not be known for
some time.
Details of the treatments are given in Table 2.
On average, from every 3 men with metastatic prostate cancer joining the trial, 1
will be allocated the control arm (Treatment Group A), 1 to the research
radiotherapy arm (Treatment Group H) and 1 to the enzalutamide + abiraterone
arm (Treatment Group J).
For all other men joining the trial who have prostate cancer that is not metastatic,
half will be allocated the control arm and half to the enzalutamide + abiraterone
arm (see Figure 1 for trial treatment allocations).
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.
Figure 1: Treatment groups in the study
1
Except pts not suitable for radiotherapy
2
All suitable patients with newly diagnosed locally advanced disease should also have radiotherapy to
the prostate
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Table 2: The Research Groups in the STAMPEDE Trial
Treatment Group A. Hormone Treatment
If you are in Treatment Group A, you will receive the standard treatment for men
with your type of prostate cancer which is hormone therapy plus, in some
instances, radiotherapy. 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.
If your cancer has not spread, your doctor will also give you radiotherapy, about
6 to 9 months after joining the trial. Treatment would typically take between 20
and 37 sessions according to local practice. (see Section 5).
Treatment Group H. Hormone treatment and prostate radiotherapy for
men with metastatic disease
If you are in Treatment Group H, you will receive the standard hormone
treatment as described in Treatment Group A plus radiotherapy to the prostate.
The radiotherapy would start within a few weeks of joining the study. It 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.
Treatment Group J. Hormone Treatment and Enzalutamide + Abiraterone
If you are in Treatment Group J, you will receive standard treatment, as described
in Treatment Group A plus the combination of enzalutamide and abiraterone. Both
enzalutamide and abiraterone will be given as a daily dose for up to 2 years.
Enzalutamide will be taken as four 40mg capsules once a day with or without food
whereas abiraterone will be taken as four 250 mg tables on an empty stomach. In
addition, one 5mg tablets of steroids (prednisolone or prednisone) will need to be
taken by mouth once a day. Treatments might be stopped sooner if your study
doctor feels they are no longer working.
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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 1).
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.
If given, standard radiotherapy should start around 6 months after starting
hormone treatment. 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.
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 1 shows which treatment groups
you might be allocated to. The radiotherapy would then take place as set out in
Table 2 above.
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.
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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 3 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 3: Possible unwanted side-effects from the research treatments
Abiraterone
Tiredness, raised blood pressure, fluid retention and low potassium levels in the
blood which therefore need regular monitoring. Other known side effects are
diarrhoea (very common), muscular weakness and damaged skeletal muscle
tissue (uncommon).
Enzalutamide
Tiredness (fatigue), diarrhoea, hot flushes, pain in joints and muscles,
headaches, dizziness, feeling weak, swollen feet and ankles due to fluid
retention, increased blood pressure and an increased risk of infection due to a
drop in the number of white blood cells. Some men have experienced seizures
and care is recommended in men who have a history of seizures, had a prior
head injury (such a stroke), have a secondary cancer in the brain or are
alcoholic; however men with a history of seizures, prior head injury or secondary
brain cancer will not be included in the trial.
There are no known interactions between enzalutamide and abiraterone.
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.
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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 enzalutamide and 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 your
treatment sessions as set out in the detail of Treatment Groups A or H.
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 enzalutamide + abiraterone (Treatment Group J) 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 2 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 receive 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 3). 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 PIS as relevant
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