Chapter 4
The Prostate
4.1
Submissions and other evidence taken by the committee concentrated
overwhelmingly on two matters - diseases of the prostate and depression. In
this chapter the committee considers the issues with regard to the prostate –
research and research funding, diagnosis (including testing and screening
issues), treatment and education and awareness.
4.2
The prostate gland is found only in males. It surrounds the urethra
where it leaves the bladder and produces a fluid which is a component of semen.
The prostate is vulnerable to a number of diseases – particularly acute and
chronic prostatitis, prostatic enlargement and cancer. Chronic prostatitis and
benign prostate enlargement are considered later in this chapter.
Prostate Cancer
4.3
Cancer of the prostate is a significant health problem and, with the ageing
of the population it is likely to become the leading cause of death from cancer
in men in the near future.[1]
Prostate cancer is the most commonly diagnosed cancer in Australia,[2]
the fifth largest cause of death among men, and, after lung cancer, the second
most common cause of death from cancer. It is predicted that the rate of
prostate cancer will rise by 3.1 per 100 000 males or 939 extra cases per annum.[3]
4.4
Over the age of 51 prostate cancer becomes the most common cancer for
the remainder of a man's life. [4]
Regrettably, despite the incidence of this disease there has been
a tendency to dismiss it as an inevitable part of the process of ageing:
...there is a concern amongst clinicians that treat prostate
cancer and researchers that because it can be labelled as a disease of old men
it is not as important. Firstly, younger men can develop prostate cancer, with
devastating consequences. That comment still occurs and it is an ageist
comment. ... As a practising clinician I do not consider anyone in their 70s to
be elderly but have an expectation that men will not lose years of their lives
or have the morbidity that can occur from disseminated prostate cancer.[5]
4.5
In this context it is important to remember that, for the purpose of
medical statistics, 75 is considered a 'normal' life span, that male life
expectancy is now 78 years and that a decision to raise the retirement age to
67 has just been announced. Thus prostate cancer is, and will remain, a
significant health issue for men of working age.
4.6
The committee believes that the case for secure long-term funding for
research into diseases of the prostate is beyond dispute. The incidence of prostate
cancer and its projected increasing incidence is sufficient justification in
itself for a considerable research effort and enhanced treatment and support
services.
4.7
The benefits that can flow from research which provides for a better
understanding of a disease and hence earlier diagnosis and better treatment can
be shown by the declining mortality rates for a number of 'common' cancers.
Colorectal cancer mortality has fallen by about 40% since the 1980s largely due
to improved early diagnosis and treatment; cervical cancer mortality has
declined by some 75% since the 1960s since the introduction of the pap smear
and deaths from lung cancer in males has fallen by nearly 40% from its peak
around 1980 as a result of the reduction in smoking and improved treatment.[6]
4.8
It is difficult to estimate the level of funding for research into
prostate cancer because it comes from a range of sources. Specifically with
regard to funding through the Commonwealth's principal funding body for medical
research, the National Health and Medical Research Council (NHMRC) prostate
cancer research has lagged behind breast cancer research. In the years
2000-2008 funding for prostate cancer was $44.5 million compared with $88.9
million for breast cancer.[7]
Given that the death rates from these two cancers are similar, that the
incidence of prostate cancer is actually greater and that projections for the
increased incidence are, by some margin, higher than for any other type of
cancer[8]
there is a very good case for an increase in funding in this area.
4.9
Prostate cancer remains relatively poorly understood and thus presents
particular problems of both diagnosis and treatment. As an internal organ,
changes to the prostate are not immediately obvious and, at present, no definitive
test short of a biopsy (which extracts tissue samples from the prostate for
examination) is available.
4.10
The committee was told by a number of witnesses at its hearings that, where
a cancer does exist, the nature of that cancer is also difficult to determine.
Prostate cancer can be largely passive or very slow growing and have no
noticeable affect on a patient (hence the saying that more men die with it than
of it). Alternatively the cancer can be aggressive and metastasise (grow beyond
the prostate itself) leading to serious illness and death.
4.11
At present the ability to determine which type of cancer a patient has
is limited:
The disease is highly variable. You can have two cancers that
look alike down the microscope. One of them will be quite indolent and the
other one will be quite aggressive. ...and we have got no marker for that at all.[9]
4.12
This problem is compounded by the fact that cancer may be dispersed
throughout the prostate and have different characteristics:
The thing is that it is a multifocal disease. It is, to a
large degree, in the periphery of the prostate but there are different cancer
foci and it is believed that they probably arise independently and therefore
may have different propensities for aggressive progression of the disease.[10]
4.13
The difficulties associated with diagnosis flow on into treatment. At
present there are limited treatment options, particularly for non-invasive
therapies.
A diagnosis of prostate cancer
also impacts on quality of life, due
to the current inability to determine and
advise the sufferer on the likely course
of his disease. This leads then to a combination of
clinical and psychosocial impacts....[11]
Research Priorities
4.14
It was put to the committee by the Institute of Biomedical Research and
Innovation that the priority areas for research into prostate cancer are:
- Development
of new predictive and diagnostic tools to identify men at increased risk of
developing PC and enhance early detection of the disease;
- Development
of new prognostic markers to distinguish between aggressive and nonaggressive
cancers to inform treatment options and minimise impacts on patient quality of
life; and
- Development
of new therapeutic options that target the genetic and biomolecular factors
that underlie specific prostate cancer types.[12]
These priorities were reflected in other submissions from
professional groups.
4.15
If significant advances are to be made in the identification and
treatment of prostate cancer, research must be supported over the whole
spectrum of relevant activities. Professor James Best summarised these as:
...biomedical laboratory-based discovery research; clinical
research, which goes out of the laboratory to involve patients in the research;
population based research, where we might look at the prevalence of prostate
cancer and whether it is increasing, decreasing et cetera; and finally health
services research, which is how is prostate cancer treated and how might we
improve the treatment.[13]
4.16
The committee strongly supports continued and increased funding for
organisations engaged in research and other activities, such as health
promotion and public education across all these areas.
The Australian Prostate Cancer
BioResource
4.17
Underlying progress in all these areas is a need for research material,
specifically tissue collected from prostate cancers.
Medical researchers will undoubtedly
uncover the secrets of prostate cancer
variability that give rise to this
complex disease. Discoveries will come from
studying the biology, pathology and
clinical outcome of tissues from a large
number of men with the disease,... More
importantly, the more cases studied the
more likely we will unravel the full
spectrum of disease...[14]
4.18
Only by being able to examine a large number of tissue samples and
follow the progress of the disease over a period of ten to twenty years will
researchers be able to make progress:
... prostate cancer tissues
really form the basis for all of Australia’s prostate cancer research, into biomarkers
of diagnosis, prognosis—that is, outcomes—and therapeutic response.[15]
4.19
A further reason for the importance of human tissue in prostate cancer
research is that the use of laboratory animals does not provide a practical
alternative:
The reason that biobanks and specimens taken from men are so
important to a biomedical researcher in prostate cancer is that you do not have
mouse models to work with. Mice do not get prostate cancer. You can make them
do that if you genetically manipulate them, but it is not something that occurs
spontaneously.[16]
4.20
The importance of being able to follow the development of a disease in
individual patients is a product of the currently unpredictable nature of the
disease:
...approximately 30 per cent of men operated on will fail that
treatment. Their cancer will have already escaped the prostate by the time they
are operated on. We cannot pick these people. Those patients will relapse in
about three to seven years after the operation.[17]
4.21
The principal prostate tissue collection in Australia is the Australian
Prostate Cancer BioResource, established in 2004, which currently collects
tissue samples from more than 10 hospitals throughout Australia.[18]
The committee is particularly concerned to ensure that this BioResource
receives secure, long-term funding to enable it to carry out the full range of
activities in support of research. It was initially funded by the
Commonwealth Bank of Australia, Prostate
Cancer Foundation of Australia and Andrology
Australia and has received funding from the NHMRC. The NHMRC grant runs
until 2009 and renewal is currently under consideration.
4.22
The committee is advised that the BioResource faces a number of limitations
imposed by resources which prevent it achieving its full potential. Financial
constraints act at both the collection and research stages. Consent of patients
to participate in the program has to be obtained and tissues have to be
collected and stored according to uniform procedures. At present the
BioResource relies,
...on the goodwill of the institutes, the medical schools that
are associated with the institutes and the pathologists who are doing things
for us gratis, although they are very busy.[19]
4.23
As a result of practical arrangements within hospitals, the scheduling
of operations and availability of pathologists for example, tissue is not collected
from a proportion, up to 30%, of men who have consented to participate in the
program.[20]
4.24
The BioResource needs to maintain the current rate of tissue collection
until at least 2014 to ensure that there is a sufficient number of tissue
samples and that these samples have been followed over a long period of time.
4.25
At the research stage the BioResource would be much more effective if it
could produce a greater range of blood and tissue products to supply to
researchers. As described in its submission the production of,
serum and plasma extracted from
blood, DNA from blood cells and prostate
cancer tissue, RNA from prostate cancer
tissue, and micro-arrays
of tissue cores of selected prostate
pathologies and disease outcomes. These materials
are used for the discovery of markers
of diagnosis, prognosis and therapeutic
response, and for determination of cancer-related
mutations and predictive genetic variations.[21]
4.26
In addition to these research activities the BioResource requires
an accessible web-linked database which would enable researchers to "...
view the collection on the database online
to determine which patient tissues are
relevant to their research study...".[22]
4.27
The committee is advised that the current level of funding,
...provides part of [the Project Manager's] salary and the
salaries of four tissue collectors, one at each node, and a small amount of
maintenance for each of those nodes. It is really only about half what we want.[23]
4.28
It should be noted that staffing of the BioResource has been delayed and
the National Project Manager only works part-time to try end ensure that
existing funding can be made to last until the end of 2009.[24]
4.29
The question of some element of self-funding of the BioResource through
cost-recovery was raised in the committee's hearings. This raises the conflict
between putting a price on a product to ensure that users value it
appropriately and discouraging its use by setting a price that is a
disincentive to use. The committee was advised that it does not charge
university and other non-profit institutions. At present it does not supply the
private biotechnology industry but should it do so in the future then the issue
of charging for tissue will be reviewed.[25]
4.30
The committee does not wish to make a recommendation with regard to a
precise level of funding for the BioResource; that is a matter for government
and the relevant professional funding bodies. However the committee would wish
to endorse the importance of the BioResource as fundamental to the conduct of
the very necessary research into prostate cancer.
The committee recommends that the Commonwealth Government ensure
that the Australian Prostate Cancer BioResource is provided with sustainable
funding at a level that would enable it to complete its tissue collection and
carry out the necessary work in support of prostate cancer research outlined in
this chapter.
4.31
An important aspect of research is the translation of that research into
better patient outcomes. It was explained to the committee that the
institutional pressures of attracting research funding and building a
professional reputation can come into conflict with the need to engage with the
general community either by publishing in non-specialist media, working through
groups such as Andrology Australia and the Prostate Cancer Foundation or
through community groups such as Rotary. At present the incentives, for example
the ranking of publications in journals, tend to favour the former activity.[26]
4.32
The committee has no ready answer to this problem. However it does
emphasise the need for continued support for organisations such as the prostate
Cancer Collaborations, Andrology Australia and the Prostate Cancer Foundation
as vehicles for bringing together researchers from different areas,
facilitating coordination of research and providing the lay reader with
accessible information on technical matters such as prostate cancer testing and
screening.
4.33
It would also be valuable if 'community outreach', which is encouraged
by research institutions, could also be given more weight in ranking
researchers and making funding decisions.
Screening and Testing[27]
4.34
This is a key area for research into prostate cancer. An effective
screening program can have a significant impact on the morbidity and mortality
of a disease. The three national cancer screening programs operating in
Australia at present are for breast cancer, cervical cancer and colorectal
cancer. Deaths from each of these diseases have been reduced considerably since
the introduction of screening programs - cervical cancer deaths have halved
from 4.0 deaths per 100,000 women in 1991 to 1.9 deaths per 100,000 women in
2006; deaths from breast cancer have decreased from 31 per 100,000 in 1991 to
22 per 100,000 in 2006.[28]
The national screening program for colorectal cancers is too recent to have
yielded significant results.
4.35
As indicated above prostate cancer can take a number of forms with
widely varying prognoses. The ability to diagnose the disease at an early stage
and to distinguish the various types of cancer and treat them appropriately is
vital. The current inability to do so leads to a situation where,
...men [are] being over-treated for cancers that they do not
need to be treated for, but we have at least 3,000 men a year who are not
getting treated, because they are dying from it. They probably could have been
saved if we knew more about what sort of cancer they had and that they needed
radical treatment. That is the number one need...[29]
4.36
The question of population based screening for prostate cancer using the
Prostate Specific Antigen (PSA) has been the subject of considerable research
and debate both in Australia and internationally. An editorial in the Medical
Journal of Australia (MJA) commented "A particular characteristic of
the debate has been the polarisation of views...to the point where, at times,
constructive debate has been constrained".[30]
4.37
Tests which provide a reliable indicator of the presence of cancer and
enable clinicians to distinguish aggressive from indolent cancers would have a
significant impact on prostate cancer treatment. To be effective the method of
screening should have a high level of sensitivity, meaning that it indicates
positive results with a high level of reliability (and yields a low level of
'false negatives' which result in cases of the disease being missed). The
method should, ideally, also have a high level of specificity; that is it
should identify those who do not have the disease with high reliability and
thus avoid 'false positives' – indicating that people who are in fact disease
free have the disease which may lead to further, unnecessary invasive testing
or treatment.
4.38
The MJA editorial referred to above identified the problems as arising
from,
...the fact that PSA is not a test for prostate cancer and has
no threshold level providing a high sensitivity and specificity...a raised PSA
level often commits men to the invasive procedure of transrectal ultrasound
(TRUS) guided biopsies.
and concluded that,
If the diagnostic process were non-invasive and treatments
with curative intent were not associated with significant unwanted effects, few
would quibble about whether it is appropriate to be tested.[31]
4.39
Two recent studies, one in the United States and the other in Europe,
have produced conflicting results and interpretations and as a consequence, did
not provide conclusive results that might have settled the debate.[32]
Andrology Australia drew three conclusions from the results of these studies:
- The results of these studies are relevant to Australian clinical
practice and provide the best evidence to date that there is a significant
level of uncertainty about the use of PSA test as a population-wide screening
marker for prostate cancer;
- Both studies highlighted the issue of over diagnosis as a result
of screening and the consequent interventions (and side effects) that would not
occur otherwise;
- The studies highlight that newer and more specific prostate
cancer markers are needed before an effective population-wide prostate cancer
screening program could be recommended or implemented.[33]
4.40
As will be discussed further below, treatment for prostate cancer can be
invasive and carries with it a number of risks. Thus when evaluating the
utility of a screening program it is necessary to compare the outcomes of
unnecessary treatment, which may result either from false positive results or
from over-treatment in the absence of a clear understanding of the particular
cancer being treated, with the benefits of mass screening.
4.41
At present it is the general consensus among medical scientists and the
Cancer Councils in Australia is that the PSA does not meet these criteria and
that, consequently, population screening using the PSA would not be justified.
4.42
Developing a better understanding of the relationship between PSA
results and prostate cancer was given as an example of the sort of research
that would be facilitated by the proposed longitudinal study on men's health.
"One of the biomedical parameters that we would undoubtedly collect in
that longitudinal study could be PSA levels from these men. Then that would
give you exactly the information that you would need and it would be
informative for people to know what does happen to people’s PSA levels and what
did happen to those men in terms of their tumour".[34]
4.43
However testing for prostate cancer where a man has general symptoms or
a family history or simply a desire to monitor their own health status should
be encouraged. Testing currently relies on a combination of a PSA test and
digital rectal examination. Should these tests indicate the presence of an
abnormality of the prostate then the patient would be referred for a biopsy,
which is the only definitive test for prostate cancer that is currently
available. The Prostate Cancer Foundation recommends that all men,
...from [age] 50 onwards would go to his GP and have a
conversation about prostate cancer. If they are concerned about prostate
cancer, they should have the blood test, the PSA, and they should also have a
physical digital rectal examination to feel whether there is any growth on the
prostate.[35]
4.44
The committee endorses the efforts of the Cancer Councils, Andrology
Australia and the Prostate Cancer Foundation to make men aware of the
importance of seeking medical advice should they have an indication of a problem
with their prostate or any of the risk factors, such as family history, which
might suggest an elevated risk.
Treatment
4.45
The significant variations in the behaviour of prostate cancer and the
difficulty in identifying the probable behaviour of the cancer in the
individual patient lead to considerable difficulties with treatment; "The
issue for prostate cancer is that we do not know which men to treat..., because
we do not have markers that are prognostic."[36]
This can lead to confusion and anxiety for patients and their families and may
contribute to people undergoing unnecessary or inappropriate treatment.
...we were seeing too many patients coming into our clinics not
knowing what their treatment options are. We work in a urology department, so
we offer surgery and that is all we offer. Unfortunately, men were coming into
the clinic and not being aware that they could have a whole plethora of other
treatment options, including radiotherapy and cryoablation—a whole range of
different things.[37]
4.46
The committee is not qualified to canvass the relative merits of various
treatment options. However it did receive a considerable volume of evidence
about the impact on patients of having to make decisions on treatment when
faced with a range of options and in many cases insufficient support and
advice:
...there are a large number of treatment options available for
prostate cancer patients and, from a psychological point of view, this can be a
very daunting task. Patients are often asked to make their treatment decision
themselves, so without specific guidance from their treating urologist or
doctor. Often patients and their families can feel a sense of paralysis around
which decision to make.[38]
4.47
A second source of anxiety is the range of morbidities which can result
from treatment including:
failed cancer control, incontinence of the bladder or the
bowel, sexual dysfunction and psychological trauma. These morbidities seem to
have a very big impact in terms of patient quality of life later on down the
track and also how they cope with these difficulties psychologically.[39]
4.48
In evidence to the committee representatives of beyondblue made a
similar but more general point:
We are now doing a lot more work in the areas of cancer, such
as prostate cancer, and major operations....The surgeon does a good job but
no-one is looking after the mind of the person. ...We are not very sophisticated
in the holistic medical approach as opposed to dealing with specific individual
issues. I think that is an area where we have to make a great deal of inroad in
the years to come.[40]
4.49
This is a major health issue. The committee heard that a large survey of
patients in NSW found that over 50% of patients had some psychological support
need and that just under 50% had a need for support relating specifically to changed
sexual functioning after treatment for prostate cancer.[41]
Prostate cancer sufferers also suffer from depression at 2 to 3 times the
community average and general psychological disorders are present in between
25% and 47% of cases. Some studies also indicate that suicide is more prevalent
among older men with prostate cancer, perhaps as much as four times more
common.[42]
4.50
Support for patients and their families both at the time of a diagnosis
of prostate cancer and in the longer term as they undergo treatment and live
with the results of it is clearly an area requiring much greater attention.
...in our work running support groups for men with prostate
cancer that there was consistent feedback from men saying that they did not
have enough support around the time of diagnosis, they did not know about the
different support agencies, they did not know that there were different
treatment options, they did not know that there were treatment options for
sexual dysfunction or where to get pads—a whole range of different things that
they just felt they were not being provided information about.[43]
4.51
The efforts of the various organisations which seek to promote public
awareness of all these problems have made a significant difference. The quality
of information that is available is excellent as are the links to support
groups. However more needs to be done to reach all prostate cancer patients and
to maintain contact with them.
4.52
During its hearings the committee was advised that a pilot project to
test a National Prostate Cancer Information Pack was underway. This is an
initiative of the Prostate Cancer Foundation and of practitioners in the field.
The pack was modelled on the Breast Cancer Foundation's My Journey kit
which is distributed to all patients at the time of a diagnosis of breast
cancer. The purpose of the pack is to provide "...credible, non-biased and
consistent information about treatment options and ongoing quality of life
issues in the context of localised prostate cancer".[44]
4.53
The report of the pilot project indicates almost unanimous support for
the pack among patients and a strong support for the major components. To be
effective approximately 18 000 Packs would have to be distributed every year.[45]
The committee recommends that the Commonwealth Government provide
funding to the Prostate Cancer Foundation to ensure that the Prostate Cancer
Information Pack program proceeds.
4.54
Outcomes for patients diagnosed with prostate cancer vary considerably
depending on place of residence and income. Patients in rural and regional
areas have a 21% greater mortality than those in capital cities. Mortality is
also related to income, with significantly higher mortality rates from prostate
cancer among socially disadvantaged men.[46]
These figures reinforce the need for improved services to be provided
throughout Australia.
4.55
Health services in regional and remote Australia generally suffer from
"...larger client capture areas, smaller populations, fewer general and
specialist medical professionals per population, and fewer services".[47]
While the provision of advanced hospital based services can only be addressed
by improving patient transport and support services to ensure that they receive
high quality treatment, local services providing education and awareness
programs to encourage men to seek medical advice and better support services,
post-diagnosis should be provided through regional hospitals, health centres or
general practice.
4.56
The committee notes, and fully supports, the Commonwealth Government's
support for a program to place specialist breast cancer nurses in health
centres predominantly in rural and regional Australia. The program, developed
in collaboration with the McGrath Foundation, is to provide:
...specially trained registered nurses...[to] provide vital
information, care and practical and emotional support to women diagnosed with
breast cancer, their families and carers.[48]
4.57
The Prostate Cancer Foundation has been providing scholarships to nurses
undertaking training in the treatment and support of prostate cancer patients
for some years but there is no program to appoint prostate cancer nurses
nationwide. The committee is advised that PCFA is undertaking a study of the
viability of such a program.
4.58
In view of the various factors discussed in this chapter; incidence,
mortality, difficulties surrounding diagnosis and treatment, the psychological
impact on patients and their families and regional variations in outcomes, it
is clear that a similar need exists among prostate cancer sufferers and their
families. A program to appoint specialist prostate cancer nurses should be
established.
The committee recommends that the Commonwealth Government expedite
funding for the provision of specialist prostate cancer nurses, particularly in
rural and regional Australia.
Non-cancerous diseases of the prostate
4.59
Benign prostate enlargement is a very common but not life-threatening
condition. It is estimated to affect 25% of men in their 40s increasing to some
75% in their 70s. It can be little more than a source of discomfort but if left
untreated may affect the functioning of the bladder and, in extreme cases,
kidneys.[49]
Various treatments are available, ranging from drug therapies to surgery
depending on severity. Bacterial prostatitis is the result of infection and,
again, can be treated with drugs or surgery depending on the severity of the
condition.
4.60
Chronic prostatitis, non-bacterial inflammation of the prostate, is
poorly understood in Australia, even by doctors and is certainly under-reported.
Evidence to the committee suggests that "...awareness of the condition and
its treatment is still poor, despite its prevalence and severity"[50]
and affects between 10 and 20% of men in Australia.[51]
4.61
In extreme cases it can be the cause of severe pain and leave its
sufferers leading 'lives of quiet desperation'. It may be a result of
inflammation of the prostate or of muscle tension in the pelvic area and can be
alleviated to some extent by anti-inflammatory drugs or physiotherapy.
4.62
All of these conditions are susceptible to treatment and benign prostate
enlargement and bacterial prostatitis can become serious problems if left
untreated. They are much more common than prostate cancer. However men may be
discouraged from seeking medical advice when experiencing symptoms because of a
fear of a cancer diagnosis. This emphasises the importance of greater awareness
of the various diseases that may affect the prostate both among the general
public and general practitioners and of encouraging men to seek medical advice
at an early stage.
The committee wishes to thank all those who made submissions to
this inquiry and participated in the committee's public hearings.
Senator Cory Bernardi
Chair
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