Download Active Monitoring

ProtecT Study
Your Guide to
Active Monitoring
This information booklet is designed for men receiving Active
Monitoring within the ProtecT study. By now you will have been
told that you have localised prostate cancer, that is, it is inside the
prostate gland, and have either chosen or been allocated Active
Monitoring as your treatment. Most people with localised prostate
cancer will never develop symptoms or problems from the
disorder. This is because in the majority of cases any tumour will
remain small and located within the Prostate. The aim of active
monitoring is:
a) To allow those whose condition remains stable to avoid
unnecessary treatment
b) To detect any change in the cancer as soon as possible if it does
occur
This booklet explains how you will be monitored and what the
options would be for the small number of men whose condition
changes while they are being monitored.
What is Active Monitoring?
Treatment details will be decided jointly by you and your urologist
but active monitoring is likely to involve:
 A Prostate Specific Antigen (PSA) test every three or six months
 Rapid appointments in the event of symptoms or other concerns
 A digital rectal examination (DRE) (if recommended by the
study urologist)
Active monitoring involves a plan of active follow-up. You will
have regular follow-up appointments with a specialist nurse who
will take blood for a PSA test. At each appointment your PSA
result will be plotted on a graph and the graph will be examined
for any evidence that the cancer is changing or growing. During
your appointments the specialist nurse will be able to discuss with
you any concerns or problems that you may have.
What will happen to men who are actively monitored?
At each visit the blood level of PSA will be compared with
previous levels. You and the nurse will look for any evidence of a
rise that might indicate that the cancer is growing. PSA is
produced by all men’s prostates and levels can vary between one
2
02/10/2003
test and another for a number of reasons unrelated to prostate
cancer. A growing cancer produces more prostate cancer cells and
therefore will produce a rise in PSA. If there were a rise in PSA
levels resulting from the cancer growing, this higher level would
be maintained over more than one blood test. Some people’s PSA
levels are also higher than others for reasons unrelated to prostate
cancer such as having a naturally larger prostate.
If your PSA blood test result rises by more than 20% from one
blood test to the next, you will be offered another blood test
straight away. This is to check whether there is a real rise in your
PSA or just a variation in the test that sometimes happens. If it is a
real rise, you will be asked to have another PSA blood test 3
months later to see if the rise has continued.
Most men’s PSA levels will either stay stable or show a temporary
rise from time to time. You do not need to do anything more if
this is the case. PSA levels may also rise slightly with age but this
has nothing to do with prostate cancer and should not cause you
concern. It is most likely that you will never need treatment for
prostate cancer or prostate cancer related symptoms.
How often will I be seen?
At first, men who receive active monitoring will probably be seen
every three months. If the PSA level remains stable you will be
able to have six monthly or yearly check-ups. However any
decisions about monitoring will be made jointly between you and
the urologist. If you would like to be seen more often, or if you
wish to be seen between regular appointments, you will be able to
do this by contacting the ProtecT study team.
Can I keep a record of my PSA results?
On page 8 of this booklet is a chart, which will be filled in each
time you have a PSA test result. This will provide a record of your
PSA results and any changes that have occurred.
The chart below shows three different patients’ PSA results over a
12 month period when the cancer remains stable.
3
02/10/2003
PSA level
Chart 1 - possible variations in PSA levels over a twelve
month period
1
2
3
4
5
PSA test
The aim of active monitoring is to identify any changes in the
cancer long before you experience any symptoms. The PSA test is
the most sensitive way to do this. We will be keeping a very close
eye on your PSA levels. The next section explains how we will
decide if the cancer is changing and what we would do if this does
happen.
It is important to remember that prostate cancer is slow growing
in most men and any change may happen over a long time
period. Treatment is unlikely to be necessary in most cases, but
may be needed if there is detectable change over a short time
period.
How can you tell that the cancer is changing or growing?
The ProtecT protocol guidelines set out levels of change in PSA
which may indicate that the cancer is growing and which would
then need further investigation. For example, if there were a rise
in PSA level over 20% in one three month period, the next PSA
result would be examined very carefully. If the next test showed a
continuation of the rise, or there were a rise in PSA level of 50% or
more in any 12 month period, you will be invited to a review
appointment with the study urologist.
4
02/10/2003
PSA level
A rise in PSA level which may indicate cancer growth
1
2
3
4
PSA test
Review appointment with the study urologist or nurse
At the review appointment the study urologist or nurse will
review the pattern of PSA levels and discuss them with you. This
will involve considering both your PSA level compared with what
would be expected in a man of your age and the pattern of change
in you as in individual. The nurse/urologist will also consider
two other factors:
a) Clinical stage
The clinical stage is an assessment of where the cancer is in the
prostate, particularly whether it is still inside the gland. Measures
are usually made using trans-rectal ultrasound (TRUS). You had
this when you had the biopsy. The urologist may ask you to have
a TRUS.
b) Grade
A Gleason grade score gives an indication of how fast the cancer is
likely to grow. The grade is assessed by examining tissue taken at
biopsy. A pathologist examines the tissue under a microscope and
gives each area of tissue a score from 1 to 5. A near-normal
appearance will be given a low score (1 or 2). In the case of more
active cancer, in which the structure of the tissue is very disrupted,
the cancer will be scored 3 to 5. To get a complete picture, a
number of samples of tissue are examined and each is scored. The
grades of the two most common types are then added together to
give a score with a maximum of 10. For example a Gleason grade
5
02/10/2003
score of 3 + 3 = 6 would indicate a medium grade cancer, a score
of 2 + 1 = 3 a low grade cancer and a score of 4 + 4 = 8, a higher
grade cancer.
Taken together the stage and grade of a cancer help to predict how
the cancer might behave. But the stage and grade are only guides
to what might happen and cancers do not always behave in the
way that might be expected from their stage and grade. While on
average a higher grade cancer is likely to grow more quickly than
a lower grade cancer, it is still not clear which treatment would be
best: active monitoring, surgery or radiotherapy.
If the urologist decides after examining these factors that the
cancer is changing, all the risks and possible outcomes of each of
the treatments available to you will be discussed with you again so
that you can decide what you would like to do. You will also be
able to discuss these issues with others if you would like to – for
example the specialist nurse or a radiotherapist.
What treatments would be available if the cancer starts to spread?
As we have indicated above, the aim of active monitoring is to
ensure that we are aware of any changes in the cancer at an early
stage and while it is still inside the prostate gland. In the majority
of cases, we believe that we will be able to detect any growth of the
cancer before it spreads outside the gland. However treatments
that attempt to eradicate or remove all the cancer are only possible
if the tumour remains within the prostate gland.
If the cancer remains within the prostate gland
If the cancer remains inside the prostate gland, you would be able
to consider having any of the three main treatments:
 Remaining on active monitoring
 Choosing either radical surgery or radical radiotherapy
The risks and benefits of each of these treatments would be
presented to you again and you would have as much time as you
liked to reach a decision.
If the cancer spreads outside the prostate gland
We expect that in the majority of cases, the cancer will still be
within the prostate gland and in this case you would be unlikely to
6
02/10/2003
have any symptoms. For a small number, the cancer may grow
more quickly and be found to have spread outside the prostate
gland. If this happens, it does not necessarily mean that you will
experience any symptoms, but over a long period some symptoms
relating to the growth of the cancer may occur. These may include
urinary symptoms or pain from the development of other tumours
(also called metastases), usually in the bones. It is important to
emphasise that the development of such symptoms among men in
the ProtecT study will be very rare – but it is possible and this is
why it is covered in this booklet.
If the cancer did spread outside the prostate, you would not be
able to have radical surgery or radical radiotherapy.
Your treatment options, if the cancer has spread, would be to
either remain on active monitoring with no immediate treatment,
have early hormone treatment and continued monitoring (see
below) or to have radiotherapy to the prostate.
Radiotherapy:
The purpose of radiotherapy treatment is to destroy cancerous
cells by use of radiation that is directed at the cancer from outside
the body (external beam radiotherapy). You would receive
treatment as an outpatient, usually over a period of 4-5 weeks.
The treatment is similar to having an x-ray and each session would
normally last a few minutes.
Early hormone treatment:
The purpose of hormone therapy is to shrink the prostate and the
cancer by stopping the production of male hormones (particularly
testosterone). This can be achieved by removing the testicles, or by
taking or injecting medication. It is possible that this treatment
may also limit the growth and spread of the prostate cancer.
Hormone therapies usually cause sexual impotence (the inability
to have an erection), can lead to weight-gain and other side effects
including tiredness, hot flushes and breast enlargement and
tenderness. Hormone therapy is also used to treat tumours that
have developed in the bones.
Again, we would explain to you in detail the advantages and
disadvantages of these treatments and give you as much time as
you want to reach a decision.
7
02/10/2003
As you get older
It is also important for you to know that urinary symptoms
become increasingly common in men (and women) as they grow
older. Symptoms include having difficulty passing urine, or
having to go often, including having to get up at night. Such
symptoms are usually caused by the normal growth of the prostate
that happens as men age. In a small number of cases, however,
such symptoms may be caused by the growth of the cancer. Other
symptoms such as blood in the urine may require further
investigation – if you experience this, you should go to your GP or
mention it to the urologist or specialist nurse when you see them.
There are drug treatments that can ease urinary symptoms. If they
become very troublesome, you might also be able to have an
operation – a transurethral resection of the prostate.
It is also important for you to remember that aches and pains in
your bones may also become more common as you get older. It is
unlikely that you will develop tumours in your bones, but if you
are worried about bone pains, contact your GP or ProtecT study
nurse.
All the time you are on active monitoring, you may request a fasttrack appointment with the ProtecT study nurse, to discuss any
symptoms that concern you.
Conclusion
This information booklet has outlined what active monitoring will
involve and what may happen in the future once you have
embarked upon this treatment. We have covered what the
treatment options may be if the cancer does spread. However it is
important to remember that most men having active monitoring
will get on with normal life without having to worry about
prostate cancer.
Some of the information provided in this booklet differs from that
provided by a number of cancer charities and other sources. This
is because at present the evidence surrounding the effectiveness of
prostate cancer treatments is uncertain – that is why we are
carrying out the ProtecT study. During the course of the study it is
possible that further information may become available which
8
02/10/2003
would allow us to advise you differently with regard to particular
treatments. If this happens we will arrange a special appointment
to let you know.
Approximately six months after you were allocated to or chose
your treatment, you will receive a follow-up questionnaire in the
post to complete. A pre-paid envelope will be provided. You will
then be seen once a year by the ProtecT study team to find out how
you are getting on and you will be asked to complete an annual
questionnaire. Please remember that at any time, if you have any
questions, worries or concerns, you are welcome to ask to see the
specialist nurse running the active monitoring treatment.
9
02/10/2003
PSA level
Record of PSA levels over a five year period
0
1
2
3
4
Years since first active monitoring appointment
5