A little below the belt

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A little below the belt
A little
below
the belt
1 A LITTLE BELOW THE BELT
AN ANZUP CANCER TRIALS GROUP PUBLICATION
Conducting clinical
trial research to
improve treatment
of bladder,
kidney, testicular
& prostate
cancer
ISSUE 2, DECEMBER 2014
Welcome
The Australian and New Zealand
Urogenital and Prostate (ANZUP)
Cancer Trials Group’s Consumer
magazine is written for patients, families,
carers, and supporters of those with testicular,
prostate, kidney and bladder cancers.
Below the Belt Consumer Magazine of ANZUP Cancer Trials group is proudly published twice a year.
Copyright ANZUP Cancer Trials Group December 2014
2 A LITTLE BELOW THE BELT
What’s inside
04
05
06
07
09
10
11
12
15
17
18
19
23
32
33
34
40
41
43
44
About ANZUP
Message from the Chair
Message from the Executive Officer
Message from the CAP Chair
Peter Stanford - bladder cancer
Chris Reason - testicular cancer
Paul Lovelace - kidney cancer
Simon Clarke - testicular cancer
Where to find safe information on the web
ANZUP clinical trials
Everyday Heroes
The Concept Development process – Dr Ben Tran
Inaugural Below the Belt Pedalthon
What does a donation look like?
Questions to ask your doctor
Current ANZUP clinical trials
Definitions and phases
Definitions and phases
Corporate sponsors
Annual Scientific Meeting 2015
ANZUP Cancer Trials Group
Level 6, Lifehouse Building
119-143 Missenden Road
CAMPERDOWN NSW 2050
Locked Bag 77
CAMPERDOWN
NSW 1450
Phone
+61 2 9562 5033
Email
[email protected]
Twitter
https://twitter.com/ANZUPtrials
Welcome to A Little Below the Belt,
our second issue of the ANZUP Cancer
Trials Group Consumer magazine.
In this issue, we meet two men who
confronted testicular and bladder
cancer head on. We also meet the
inspirational Simon Clarke. Simon
introduced himself to ANZUP a little
more than 12 months ago as a 25-yearold who had recently undergone
treatment for testicular cancer. He
wanted to create a vehicle that would
raise much-needed funds for ANZUP as
well as raise awareness of “below the
belt” cancers.
“Below the Belt Pedalthon” was
extraordinary. So too were the funds
and awareness he raised to support
ANZUP.
In this issue, we also explore the
journey taken by patients and their
families as they navigate the health
system after a diagnosis of cancer. We
hear from social media expert and
ANZUP employee Jenni Beattie who
provides insight into the best places to
find credible information online.
Every new treatment emerging from
ANZUP begins as a concept – an idea
developed when specialists identify
a gap or possible improvement in
treatment. In this issue, Dr Ben Tran,
medical oncologist, answers some
questions and provides a step-by-step
overview of how an idea becomes a
trial. This also ties in with the need for
independent funding that will allow
ANZUP to take these trials to concept
stage far more quickly than we can
now.
We hope you enjoy this issue of A Little
Below the Belt.
A LITTLE BELOW THE BELT 3
About ANZUP
The Australian and New Zealand Urogenital and
Prostate Cancer Trials Group was founded in 2008
and is a registered, not for profit charity.
ANZUP’s mission is to conduct clinical trial research
to improve the treatment of bladder, kidney,
testicular and prostate cancers.
ANZUP is a cooperative and multidisciplinary
organisation including collaborations within Australia,
New Zealand and international collaborations.
ANZUP was formed as a national cooperative clinical
trials group encompassing all urologic cancers
(prostate, kidney, bladder/urothelial, testis and other
related tumours).
ANZUP currently has members from Australia and
New Zealand from all relevant professional medical,
nursing, allied health, basic science and other
disciplines. The ANZUP Consumer Advisory Panel
(CAP) provides a mechanism for advice to be offered
across all ANZUP research activities as well as
ensuring community engagement.
Cancer Australia primarily funds ANZUP through its
Support for Clinical Trials program.
ANZUP is about the patient
and their families. It is about
evidence-based research that
changes the way these cancers
are treated in Australia and
around the world.
Ian Davis, ANZUP Chair
Research trials outcomes
Welcome to this edition of “A Little Below The Belt,” the
ANZUP Consumer magazine!
ANZUP is the Australian and New Zealand Urogenital and
Prostate Cancer Trials Group. ANZUP exists to improve
outcomes for people and their families affected by cancers
of the urinary system (prostate, kidney, bladder and
testicles). We represent all groups involved in the care of
people with these cancers, as well as the researchers who
are trying to understand why these cancers behave as they
do and how we can improve our treatments. A belt won’t
hold your trousers up if the loop is not closed. In the same
way, we cannot improve outcomes for these “below the
belt” cancers unless we close the loop of research. This
means taking the discoveries that have been made and
working out what they mean in terms of how best to treat
these cancers. ANZUP is the “belt buckle” in that process
and in another sense we are “braces” as well – we provide
support and systems to bring people together to do this
research that is so desperately needed.
How do we do this? Improvements in health outcomes
only come about when the right questions are asked and
answered. Here are some examples. If a scientist finds
that a particular gene is important in a certain type of
cancer, how do we take that information and turn it into
a treatment? How do we know which particular people
might benefit from those treatments? How do we know if
this treatment is better than what we had before? How do
we know what effects the treatment might have on that
person? How do we help people cope with the effects
of that cancer or its treatment? How do we take all that
information and get the health system to change to a
better way of doing things? How do we know that this
is cost effective, both economically and in terms of the
unseen costs and problems that our patients and their
families experience?
The only way to do this is through clinical trials. All the
4 A LITTLE BELOW THE BELT
Message from the Chair
IAN DAVIS
ANZUP provides
the opportunities
that health carers
and researchers
need to come
together and
share their ideas.
Ian Davis, ANZUP Chair
wonderful laboratory research done in Australia and
overseas is very important to provide us with the ideas we
need, but unless we prove that we are making a positive
difference to people then all that previous research counts
for very little. Doctors and other health practitioners need
to be able to rely on evidence in order to recommend
treatments and give them safely and appropriately. ANZUP
performs the clinical trials that generate that evidence.
What else do we do? ANZUP provides the opportunities
that health carers and researchers need to come together
and share their ideas. We need to be constantly on top
of all new (and old!) developments. We need to share
our clinical insights so that we can understand where the
gaps in our knowledge are. We need to train the next
generation of researchers, to continue the work and ensure
that this momentum is not lost.
A key part of this is how we communicate with the broader
community. ANZUP takes this very seriously. We have
connections with a wide range of stakeholders including
various advocacy groups. We are privileged to have a
wonderful Consumer Advisory Panel, comprised of people
who have been affected by the range of cancers we study
and who have strong links back into the community.
This means that ANZUP is constantly listening to what
the community sees as being important. Our Consumer
Advisory Panel members also participate directly in the
research we do, by helping us generate information that
is understandable, by being included on various grant
applications, and by helping us raise the funds we need to
do this important work. We are very grateful to all of them
for these fantastic contributions.
It also works in the other direction. ANZUP listens, but we
also have a responsibility to speak to the community to
inform them about these cancers and about the outcomes
of this research. This magazine is one way of doing that
and you will read about these things in the following
pages, but we also use our web site (www.anzup.org.au),
Community Forum meetings, and other special events. We
must never lose sight of why we are doing the work we do:
it is for our patients and their families.
This edition of the magazine is packed with information.
You will read about personal experiences with cancer.
You will get an idea of how ANZUP takes a concept and
develops it into a full grown research project. You will
see that ANZUP is deeply involved in supportive care,
including support groups and also looking at the role
of carers. You will get a snapshot of the research we are
currently doing or planning, and you will find links to more
information if you want it. You will see some amazing
work done by our supporters to raise funds for ANZUP’s
work, including our recent Pedalthon that exceeded all
our hopes in terms of raising awareness and additional
resources for our work.
I’m proud to be part of an organisation like this. It is hard
work though, and it takes a long time to do it properly
(much longer than any of us would like), and it is usually
very expensive (much more than most people realise), and
most of us have jobs and other responsibilities in the nonANZUP world too (hello to my wonderful wife – remember
me?) ANZUP is a not-for-profit charity and we rely on
various sources for our funding, including government
and other grants, but those only go so far. They certainly
do not extend to covering the costs we need actually
to do the trials we need to do. ANZUP is now moving
into the fundraising field, and you all know very well that
there seems to be constant requests to dip into your
pockets. We recognise and support the work that other
fundraising groups do but we do have an important point
of distinction: we are the only group actually doing the
clinical trials that make all the underlying research actually
mean something. Please do not hesitate to contact us if
you want further information about all this. We are grateful
for all your support and we know that this support goes
way beyond the financial. Every bit of it goes directly to
help us reach our goals of improving outcomes for our
patients.
Thanks for your interest in ANZUP. I’m sure you will find
much of interest in this magazine.
A LITTLE BELOW THE BELT 5
Message from the Executive Officer
MARG MCJANNETT
What a year we have had!
As the festive season is upon us, I think it’s worth taking a
moment to reflect on the some of the highlights of the past
12 months.
In March, we launched our inaugural Community magazine
“A Little Below the Belt”. It is our intention that this
publication will provide you with important, accessible and
accurate information on the work of ANZUP. We encourage
you to share it with friends and family.
The Annual Scientific Meeting (ASM), held over three days
in July, was once again a resounding success. Officially
opened by Victorian Parliamentary Secretary for Health,
Ms Georgie Crozier MLC, delegates were treated to a
scientific program of exceptional quality. Throughout the
meeting, our international faculty were extremely generous
with both their expertise and engagement. They were
ably supported by a superb line up of local speakers and a
record number of poster presentations. The broad range of
topics covered provided delegates with detail of the most
up-to-date management of urological cancers, as well as
the psychosocial aspects of treatments and the translation
of cutting-edge scientific discoveries. There were also
updates on current ANZUP trials, and the very interesting trial
concepts presented generated a large amount of discussion.
Hopefully they will lead to important trials in the future.
This regular event ensures we are on top of world class
information that ultimately translates into better outcomes
for patients
We are extremely grateful to our generous Consumer
Advisory Panel, chaired by Belinda Jago: Ray Allen,
Matthew Carr, Joe Esposito, Colin O’Brien, Tony Sonneveld
OAM, David Swallow, Max Shub, John Stubbs and Peter
Stanford and Bill McIlrath for their continued support and
collaboration during 2104. Their involvement in diseasespecific teleconferences and ASM planning is vital to
ensuring we continue to have a consumer voice at the table.
Our Community Engagement Forum at the ASM is another
opportunity to provide the community with information
about ANZUP, the importance of clinical trials, and the
impact a urogenital cancer diagnosis may have on a person
and family. We were joined by an experienced team of
ANZUP members who engaged and encouraged audience
participation. You will be able to read more about this in
Belinda Jago’s article on Page 7. Connecting with the
community can be quite a challenge and this year, largely
due to the extraordinary efforts of Liz Thorp, we saw a
significant increase on last year’s numbers with more than
65 community attending. Please consider promoting these
events to friends or families if you feel they would find them
beneficial.
We also launched our new ClinTrial Refer App (see p39)
which provides a current list of ANZUP clinical trials
underway in cancer centres in Australia and New Zealand.
Designed for patients, oncologists, general practitioners and
research unit staff, it offers searchable clinical research trial
details, hospital locations, inclusion and exclusion criteria,
and lay summaries. We hope this will help the broader
community identify trials that they may wish to discuss with
their doctor.
A little more than a year ago, I was approached by a
remarkable young man - Simon Clarke, a testicular cancer
survivor - who had decided during his treatment that
he wanted to create an event to build awareness and
raise funds for urogenital cancers. As a consequence he
established the Below the Belt Pedalthon. The inaugural
event was held at Eastern Creek on 16 September
2014. The rest, as they say, is history. Through Simon’s
extraordinary determination and commitment, ably and
tirelessly supported by Liz Thorp, the Pedalthon was, by
all measures, a HUGE success. It not only raised significant
funds to support ANZUP’s research activities but also
opened the door for us to better engage with the corporate
sector. Our sincere thanks go to Simon and his wonderful
family, Dad Andrew, Mum Sally, sister Rose and brothers
Cam and Will, and extended family and friends, for their
support and generosity. The funds raised will go towards
clinical trials research, and concept development meetings
to progress our research have already taken place. You can
read more about the Pedalthon throughout this magazine.
Thank you for your ongoing support.
ANZUP would not be able to achieve its high levels of
activity without the support, input and commitment of the
community.
Don’t forget to SAVE THE DATE for the Community
Engagement forum where you can meet the experts, 12 July
2015 at the Sofitel Sydney Wentworth. Admission is free,
registration on the ANZUP website. Look forward to seeing
you there.
I wish you and your family best wishes for the festive season.
6 A LITTLE BELOW THE BELT
A message from the ANZUP CAP Chair
BELINDA JAGO
The ANZUP Consumer Advisory Panel (CAP) plays a vital role in the provision of advice
and feedback from a consumer perspective on issues as diverse as the direction of general
research to community engagement and support. The CAP chair is Belinda Jago who brings
a particular knowledge base to the voluntary role through her own experiences as carer to
her daughter Bec, who succumbed to kidney cancer at the age of 19. Here she speaks of
the CAP’s involvement in the Annual Scientific Meeting, and panel plans for the year ahead.
The ANZUP Annual Scientific Meeting (ASM), which takes
place in mid-July, provides a key opportunity for CAP
members to take part in education sessions which help
them provide the most constructive input into ANZUP
clinical trial research from a consumer perspective.
It also gives CAP members, who through the rest of
the year work in small groups or via teleconference,
the chance to meet face to face as well as meet with
clinicians and researchers.
Each year, a Sunday session of the ASM is dedicated to
pre-meetings - mostly education sessions for specific
interest groups. These include:
l A master class for trainee medical clinicians and allied
health professionals, focusing on case studies
of different urology cancers;
l A community engagement
forum offering up-to-date
information on ANZUP clinical
trials and the benefits
of being a clinical trial
participant;
l Importantly, from my
perspective as Chair of the CAP, our half-day
education session for
all CAP members.
To be a member of the
CAP, you will have been
a cancer patient or carer
of a family member or
close friend, and will have
a keen interest in clinical
trial research and a passion for
advocating to the community the importance of
clinical trials.
The education sessions inform our personal experience
with knowledge about the clinical trial processes: how
they start as an idea and, hopefully, end up being the
newest and best standard treatment for cancer patients.
All the research at ANZUP is about improving outcomes
for cancer patients and their families.
We are fortunate that many expert researchers and
clinicians offer their time to the CAP at these meetings
through sessions on subjects such as funding for clinical
trials and the grant submission process, the role of ethics
in approving a clinical trial, the use of statistics, and the
different types of trials developed around proving
different theories.
These learning opportunities
ensure that we have the best
possible understanding of
the clinical trials process
including timing issues,
and complexities around
ethics and funding
approvals, to ensure we
can actively engage
and contribute to
ANZUPs research
activities. We also get
the chance to discuss
our own processes
for reviewing clinical
trial concepts, what
works best, and what
we can do to improve
our feedback to clinicians
and researchers. We
also consider the technical
A LITTLE BELOW THE BELT 7
language used by clinicians and researchers, and encourage
“lay” language summaries for all clinical trial proposals to make
sure they are understood.
Meeting face to face also means we meet with some of the
clinicians and researchers who sit via teleconference with CAP
members on the various disease subcommittees. Even just a
short meet and greet helps to make these meetings a more
successful experience.
These disease specific subcommittees are the engine room
for considering new ideas and for building concepts for future
clinical trials. It is essential for consumers to have input into the
design of these trials from a patient point of view. This ensures
it is more than likely there will be some benefit to the patient.
Quality of life is always a very important consideration.
It is essential for consumers to have
input into the design of these trials from a
patient point of view. This ensures it is more
than likely there will be some benefit to
the patient. Quality of life is always a very
important consideration.
The CAP is then given the opportunity to attend the next two
days of the scientific program. While this is more technical
in nature, the guest speakers, presenting a broad range of
information, are always of high calibre. There are probably
only ever one or two sessions that “fly” over our heads!
Support for, and inclusion of, the CAP by ANZUP ensures that
we are a committed and enthusiastic group, very interested in
assisting with input into ANZUP clinical trials.
As we head into December 2014, planning for the year ahead
and next year’s ASM has already begun. Our aim for the
coming year is to appoint a Deputy Chair of the CAP to assist
the Chair and provide cover for meetings if I am not available.
We also hope to have at least two CAP members for each
of the disease specific sub-committees and nominations for
these are normally sought through ANZUP clinicians. That is
how I ended up being connected to ANZUP.
We are now a more experienced CAP with most members
having been on board for two or more years. More clinical trial
research and more consumer involvement will be needed as
ANZUP continues to grow. As a CAP member, it is exciting to
be part of this successful and growing organisation.
The ANZUP Consumer Advisory Panel at the 2014 ASM: L-R Back row: John Stubbs, Ray Allen, Joe Esposito, Leonie Young, Max Shub, Colin
O'Brien, ANZUP EO Margaret McJannett, David Swallow, ANZUP Chair Ian Davis. Front Row: CAP Chair Belinda Jago and Tony Sonneveld OAM
8 A LITTLE BELOW THE BELT
The journey
A great story evokes emotion, persuades,
even compels. More importantly, people who
have felt something while being lost in a good
story want to share it.
(Adobe)
We hope you are touched by the following stories.
Open Communication
the key for Ostomy Support Group
Meet Peter Stanford, an Ostomy
Support Group facilitator at the
Cancer Support Centre, Jacaranda
Lodge, Sydney Adventist Hospital.
Peter joined the group in 2009
after he had bladder cancer
surgery and had a stoma fitted.
He had been a group member for 12 months when
Mike the facilitator asked him to be his 2-i-c.
Peter facilitates the Stoma peer support group run on
the first Wednesday of each month (details below).
The 15 members have a range of stoma (colostomy,
ileostomy and urostomy) resulting from either bowel or
bladder cancer. The support group session involves a
mix of peer group chat and professional presentation.
In the first hour, members talk about any issues from the
previous month while the second hour is given over to a
speaker. Speakers come from a wide range of expertise,
such as stoma appliance specialists, stoma nurses and
dieticians.
The hour dedicated to sharing thoughts and emotions
in an environment of trust is important and all members
know that what is said in the room stays in the room.
It is a chance to open up, share information and
feelings. Confidentiality is key and people know they
can share sometimes very personal issues and not be
judged. Some of the issues that come up regularly
include leaking appliances, wind, skin irritations and
relationships.
New members often hear about the support group
from GPs, stoma nurses, or from reading material. They
contact the Cancer Support Centre at Jacaranda Lodge
and are then introduced into the group. Members
are welcome to come alone or with a carer or family
member. Some members stay part of the group for
years while others may only attend a few sessions.
Peter listed the key benefits of the support group as:
Camaraderie: All members have stomas. Being part of
the group makes them feel less isolated and helps improve
coping skills and sense of adjustment.
Openness: The peer group is a very open and
supportive environment.
Information Sharing: From ostomy appliance suppliers to
dieticians and nurses – the ostomy area develops rapidly
so it is important members hear the latest information. This
gives them a sense of empowerment.
Peter’s final word about the support group is
‘communication’. In an age of online technology, good,
old-fashioned, face to face communication helps break down
barriers, forge friendships and strengthen trust and support.
Peter said “It is very satisfying to see a member come to
the group unsettled and stressed and leave with a smile
on their face”.
Cancer Support Centre, Jacaranda Lodge
Ostomy Support Group
Meet: 1st Wed. 10.00am – 11.30am monthly
Jacaranda Lodge, Sydney Adventist Hospital,
185 Fox Valley Road, Wahroonga. NSW
Contact: Nerolie. Phone: 02 9487 9061
Peter is a member of the ANZUP CAP and sits on
the bladder subcommittee.
Relevant Links
lAust Council of Stoma Associations
http://www.australianstoma.com.au
lCancer Council NSW http://www.cancercouncil.com.au/
lJacaranda Lodge http://www.sah.org.au/jacaranda-lodge
l Stoma Frequently asked questions and answers
http://www.australianstoma.com.au/index.php/facingostomy-surgery/2-uncategorised/25-frequently-askedquestions
lOther sources of information www.cancerresearchuk.org
A LITTLE BELOW THE BELT 9
The journey
Chris Reason
Just last year, I passed an important milestone.
Ten years in remission.
It was a day I honestly thought I’d never see, but every
day I thank the heavens I did – because so much has
come into my life in this disease-free decade:
A wonderful wife, two extraordinary children, great
friends, and some amazing life moments.
And I like to think that all of those moments feel so much
better – when you know how close you came to never
having any of them.
Cancer is evil on every level but it does have one benefit it teaches you the value of life.
Not that I was feeling any of that wisdom when I was first
diagnosed. I’ll never forget that moment. I was sitting in
my urologist’s surgery, he was flicking through his desk
diary, and asking about the best time for an operation. His
head was down and I honestly thought he was talking into
a hands-free phone. But then he looked up at me: “We
should operate tomorrow morning – are you available?”
he asked.
Ten minutes later, I was outside in the corridor, alone and
crying. I couldn’t believe that the breakneck-speed of my
life had suddenly come to this crashing halt.
Initially it was fairly simple and straightforward - I had one
testicle removed and some follow-up radiotherapy.
But the cancer returned – it spread up into my abdomen
and required intensive chemo and finally a marathon
operation (a RPLND - a Retroperitoneal Lymph Node
Dissection). That procedure not only took 9 hours to
perform and 57 metal stitches to repair - it also took the
tumours. We’d beaten it! What a feeling.
I say “we” of course because it was a team effort – my
urologist Dr Peter Nash, the oncology nurses at North
Shore Private Hospital, the surgery team at St George’s
Hospital, my family and my friends.
But one thing I noticed that was missing from the team
was outside support.
I was surprised that through all the months of the ordeal
there was little I could find that offered cancer fighting
advice, experience or wisdom. There was no ‘beenthere, done-that’ bloke that I could talk to. And as
accommodating as the nurses were, I didn’t think it fair
to ask them intimate questions about testicles, sperm
counts, sexual function! At times it felt pretty lonely. There
were no other blokes in my chemo ward with testicular
cancer. And outside the hospital, the subject was one that
people had difficulty talking about, understandably. It was
even awkward with family.
10 A LITTLE BELOW THE BELT
Chris Reason and Kathryn Robinson with twins Lucy and Sam.
Photo: Paul Lovelace
At times, the ordeal became a pretty isolating experience.
I remember at the very low point of the battle, when the
outlook wasn’t looking great, I was starting to spiral into
depression. The nurses booked me into a psychiatrist. It
was the first time in my life I’d had to see one.
So when I emerged from my ordeal, I decided I wanted
to try and help other blokes who might be about to go
through it all. The NSW Cancer Council had launched
a program called “Cancer Connect” – it was a phone
counselling service for cancer patients. They needed men
who had experienced testicular cancer – so I jumped
in to help. After a very basic introduction course on
counselling, I became part of the program and for the
next five years I took random calls from blokes old and
young battling testicular cancer in its various forms. I’m
not sure how much value I was to them, but I can certainly
say the experience was of enormous value to me.
I’ve left the program now – but I’ll never forget the guys I
met through the many, many phone calls.
They are among the many ways I will always remember
my own cancer survival - along with the 30cm scar on my
abdomen, my chemo-damaged lungs, and the threetimes a year testosterone shot in my backside!
That last one is literally a pain in the arse – but it’s better
than the alternative!
Chris Reason
Senior Reporter and Presenter, News. Channel 7
Paul Lovelace, a Sydney-based
professional photographer, shares his
family’s traumatic cancer story in support
of the need for ongoing clinical research
into better treatment – and the ultimate
goal of finding a cure.
Kathleen Lovelace
Photo: Paul Lovelace
Kathleen Lovelace
No one other than those who have experienced it can
understand the emotional pain, bafflement, even resentment, of losing someone close to a relentless cancer.
Doctors now moved on to a new mode of treatment. Paul said
that at the time clinical trials on cancers were underway with
the drug Interferon and it was recommended for Kathleen. The
trials had shown potential and Kathleen decided to go ahead.
Nurses taught her how to self-inject a dose of the drug which
she did at home each day for six months.
The impact can be even more poignant if there have been times
of hope sparked by apparently successful treatment regimens
and remissions.
It is this period that leaves Paul with the most questions about
his mother’s treatment.
For Paul Lovelace, the agony of losing his mother Kathleen to
cancer in England more than two decades ago is still raw, not
only because of the way she was affected by the disease but also
because he believes there are unanswered questions about her
treatment.
“There was no chemo or radiation therapy. I remember my
father saying later that the doctors had made a mistake – that
they should have followed the surgery with chemo,” he said.
“When you reflect on the treatment process you have to ask
why they didn’t follow up.”
But rather than focus on the negative, he has turned that
frustration into a trigger to strongly advocate for any clinical
research that may lead to a breakthrough in the cancer battle.
Despite great positivity from Kathleen and her family towards
Interferon it became obvious that the drug was failing. Sadly,
from that point on, deterioration in her condition was rapid.
His is the type of story that helps inspire anyone who works
with ANZUP to strive to develop new ways to tackle “below the
belt” cancers. It is also a stark reminder, should any be needed,
of the toll on those left behind and the importance of clarity of
treatment message and emotional support.
“After about two more months, she just got sicker,” Paul said.
“She went into hospital for a week or two to manage the
sickness symptoms and then a hospice nurse was allocated to
us at home for a week where she died.”
Kathleen was in her early 60s when a shock diagnosis confirmed
a kidney tumour.
The onset of the symptoms had been sudden. The first signs
appeared one afternoon, just before lunch with friends: pain,
nausea and a general feeling that something wasn’t quite right.
Over lunch the symptoms disappeared only to reappear later. It
was enough to prompt Kathleen to visit her GP who referred her
on for x-rays and scans.
The tests revealed the tumour, but there was some encouraging
news: her doctors said they believed that its removal through
removal of the kidney would eliminate the problem and allow
Kathleen to go on to lead a healthy life.
“You just feel so helpless. It hurts you so much.”
Some years after the death of his mother, Paul was again
touched by the cancer scourge. His father, who had been a
smoker, was diagnosed with lung cancer and succumbed to the
disease.
Losing both parents to cancer has added to Paul’s strength of
advocacy for any research that might lead to better treatment.
“The fact that both parents died of it is always at the back of
your mind,” he said. “I am all for any drug or clinical research
that can help people or find a cure.”
Despite the failure of the drug regimen to help his mother, Paul
also believes that the potential of the Interferon trial did have a
positive effect, albeit for a relatively short time.
After the surgery, the period of respite was short.
“She had the surgery, but three months later the tumour came
back – in the area where the kidney had been removed,” Paul
said.
Thanks to Paul Lovelace for providing the picture he took of Chris
Reason and family. http://www.paullovelacephotography.com.au
A LITTLE BELOW THE BELT 11
The journey
Below the Belt Pedalthon founder
Simon Clarke tells of his cancer
journey and just what set the
wheels in motion on a hugely
successful fund-raising venture.
As a young adult cancer was always an unknown and
ominous concept but one I felt I shouldn’t have to
consider “until I was older”. Yet in 2012, at the age of 24
- and on the cusp of completing my university degree - I
was diagnosed with testicular cancer.
With what felt like fairly innocuous symptoms, the
diagnosis was a huge shock - so much so that I didn’t
know what else to do but pretend nothing had happened
and to go back to work. I had never really heard of young
men having to deal with anything like this. But why should
I have? I’ve since come to realise that is half the problem.
Despite its limited public profile, testicular cancer is the
most common among young men yet so rarely spoken
of. For men, any discussion of what is going on below the
belt is often perceived as taboo or met with sniggers. As
I began my adventure through the hospital system and
waiting rooms I was amazed to find more and more stories
with this mentality.
Throughout treatment (and now a couple years into
remission), my initial shock turned into an overwhelming
desire to give back and to find a way to help others in a
situation like mine. Most of all I was touched by the impact
I had in telling my friends and family that it’s ok to talk
about these things. It is not embarrassing, or a stigma,
but something that I can actually be proud of - or perhaps
worth a good laugh (if only someone had told me that the
iPhone app Snapchat would be so popular before I made
the username cyclops-sim).
With this backdrop, I founded Pedalthon in 2013 - a
vehicle to promote awareness and raise critical funds to
enable ANZUP to improve the treatments and outcomes
of below the belt cancers. Pedalthon’s flagship event,
I founded Pedalthon in 2013 a vehicle to promote awareness and
raise critical funds to enable ANZUP
to improve the treatments and
outcomes of below the
belt cancers.
Simon Clarke
12 A LITTLE BELOW THE BELT
where teams competed for four hours to help defeat four
cancers, was held in September 2014. Through months
of hard work, and an incredible team, our inaugural event
attracted about 250 riders across 35 leading corporate and
community enterprises. Our combined efforts were able to
raise funds net $222,000 and also received recognition from
Prime Minister Tony Abbott. It is incredibly difficult to sum
up the level of overwhelming support Pedalthon received perhaps something that, initially, we could only dream of. I
have been incredibly touched by the way major corporate
firms responded to the call to arms. For mine, this target
market holds a critical key to unlocking public perception of
below the belt cancers and the camaraderie, esprit de corps
and sincerity to the cause that each and every one showed
was truly special.
While I’ll never forget the streams of beaming smiles, perhaps
the most moving success out of this year’s Pedalthon was in
two separate messages I received from people I had never
met before - one from the USA and the other closer to
home. Both had stumbled across our message and reached
out to say they had been inspired to seek medical advice
for themselves. Fundamentally this was the achievement
of one of our main goals: to change how we view, act and
respond to these cancers. It is for reasons such as these that I
believe Pedalthon was able to carve a niche in what is a quite
saturated market for charitable effort, and to touch everyone
it came across in a way that can only continue to make a
difference. Our aim is to grow the event in the coming years
– both in terms of participants and funds and, in doing so, to
continue to broaden the cycle of awareness.
I’m incredibly fortunate to have come across ANZUP and
its fantastic staff. I am constantly in awe of the work that
ANZUP’s member base is able to achieve and am excited
at the prospect of what is possible. I would like to take this
opportunity to thank the community for getting behind this
event and thank the staff of ANZUP for their support, patience
and most of all for their efforts in helping the lives of so many.
If you have any comments, questions or would like to
participate in next year’s event I would love to hear from
you at simon[email protected]
Far left:
Simon
Clarke with
his mother Sally
Jones on race day.
Photos: Getty
he was in the final period of exams for his commerce
and science degree at Sydney University and was also
working as an intern.
The ache was constant. “There was nothing to see and
initially the doctor told me not to worry about it. But it
still didn’t go away and so two weeks later I went back
and said ‘I just don’t feel right’.”
The pain was coming from his lower abdomen, towards
his right groin, and the doctor ran tests which showed
nothing. But Clarke persisted and his doctor upscaled
the tests. Within another two weeks he had a CT scan
and an MRI.
My life had changed
in 20 minutes
When testicular cancer
turns a young man’s head
Jill Margo Health editor,
The Australian Financial Review
As soon as he left the doctor’s con­sulting rooms, Simon
Clarke got into his car and opened Google. The shock
hadn’t quite hit him as he scrolled down and began
looking for information about testicular cancer.
At 23, he was entirely unprepared for the diagnosis he
had just received. Not only had he never met anyone
with this type of cancer, but he had only vaguely heard
of it and had e
­ rroneously assumed it was something that
affected older men.
Now, sitting outside the family ­doctor’s rooms on Sydney’s
north shore, he couldn’t absorb what he was reading and
he noticed his lunch break was almost over.
“I didn’t know what else to do so I drove back to work,“
says Simon, then an intern at corporate advisory firm
Gresham Partners. By evening, the news had sunk in and
he told his p
­ arents. Then he told others.
A few weeks earlier, in early Nov­ember 2012, he’d felt a
dull ache in his stomach. It was a stressful time because
Then he got the phone call and
slipped out to the appointment
during lunch. “I remember he looked
down and told me I have testicular
cancer. I didn’t even know [that possibility]
was on the table and there we were, discussing
an operation.
“In the space of 20 minutes my life had changed.”
And the change would be significant. It would shift
Clarke’s focus off himself. Rather than taking privilege
for granted, he would realise what he had and what he
could potentially do for others.
Born to Australian parents in New York, he had spent
part of his childhood there before the family
returned to Sydney and he went to Knox
­Grammar, where he excelled academ­ically
and at sport.
Apart from several sport-related broken bones, he had
been in excellent health. The world lay open before
him. He’d travelled widely and there had never been
cause for him to pause to consider where he was
going.
The diagnosis, however, stopped him in his tracks.
“Despite solid family support, it was a solitary time and
This story is reproduced with permission. Published 25 June 2014
A LITTLE BELOW THE BELT 13
Now an associate at Gresham, Simon has two personal
goals. He wants younger men to know about male
cancers so they don’t ­stumble into it the way he did. And
he wants to raise funds for research to understand more
about these “below-the-belt” male cancers.
The Below the Belt Pedalthon
Such research is conducted by ANZUP, Australian and
New Zealand Urogenital and Prostate Cancer Trials
Group. It is the kind of research that can’t be done by
drug companies.
Using his own funds, and with the support of ANZUP
and the help of friends, Simon has organised a cycling
challenge at The Sydney Motor Sport Park (Eastern
Creek) this September. Called the Below the Belt
Pedalthon, it challenges teams to complete the most
laps possible within four hours on the closed track.
Simon Clarke with NSWIS Development Cyclist
Nathan Bradshaw. Photo: Getty
Throughout the day there are also a series of mini
challenges. In true race style, garages in the main pit lane
will accommodate teams of up to eight cyclists each.
it gave me an opportunity for introspection I might not
otherwise have had.”
The teams – of men and women and of both avid and
recreational cyclists – will be drawn from the ­business
­community.
He spent Christmas in hospital having surgery to
remove his right testicle and during his recuperation he
began reordering his priorities.
Testicular cancer is a
younger man's disease
He’d noticed the impact his diag­nosis had on friends.
While they joked about it and suggested he get an
upsized prosthesis and a specially tailored suit to show
it off, they were deeply shocked. They too didn’t know
that testicular cancer is a younger man’s disease and
that in Australia, the average age of diagnosis is the
mid-30s. It was so confronting, Simon wished he’d
been forewarned.
To safeguard his fertility he had banked sperm before
the operation and had then declined a prosthesis,
preferring to live with himself the way he now was.
But what to do next? The lack of ­consensus among
his specialists was worrying. “I was constantly trying to
learn more about my options, but what scared me was
that in the space of a couple of weeks, I saw multiple
­specialists and they all advised me to do slightly
different things. One said I should do chemo, one said
I should have radiation and another said I should do
nothing, just be in remission and have regular tests – if
it spread I could take further action then.”
Simon took comfort from the fact that testicular cancer
is highly treat­able, with relative survival higher than 97
per cent. While he prefers not to use the word “cure”,
he opted to watch and wait.
“It was a tough decision and now every quarter I have
scans and a series of tests to make sure there are no
signs of cancer.”
14 A LITTLE BELOW THE BELT
For his target market Simon is following a model set by
the JPMorgan Corporate Challenge, which began as a
modest fun run and is now a major international event.
Simon – who is not to be confused with the professional
Australian cyclist of the same name – devised, wrote and
published a sponsorship prospectus and has a target
profit of $100,000 in the first year.
All funds raised will go directly to ANZUP, apart from a
minor fee to the fund-raising platform. While the group’s
infrastructure is funded by ­Cancer Australia, each clinical
trial needs its own funding stream, so ap­plying for grants,
which it does, can take several years.
A pilot study to test the feasibility of a promising drug,
surgery or other supportive care might be able to be
done for smaller amounts of money depending on the
trial, around $50,000-$250,000. A meaningful clinical trial
usually requires more than $1 million to begin.
What to look for
Common symptoms of testicular cancer
l
l
l
l
l
Painless lump or swelling in either testicle
Change in how the testicle feels
Ache in the lower abdomen or groin area
Sudden build-up of fluid in the scrotum
Pain or discomfort in a testicle or in the scrotum
Several conditions may cause these symptoms,
but if you experience one of them see a doctor.
Source: Cancer Australia
The journey
Searching
for Credible
Health Information
Social media expert Jenni Beattie provides an insight into
how to find credible health information online.
The power of the internet means that today, more than ever, there is a wealth of
information available to help inform our health decisions. While this offers big
advantages, it can also leave us feeling overwhelmed. In this article, we hope to
provide some tips to help you navigate your way around this increasingly complex
information environment.
‘Social media’, ‘online media’, ‘websites’ .… the range of online health information is
dizzying! If you have ever searched for health information online you will appreciate
that, at times, making the best choices can be both time consuming and stressful.
Jenni is the Internal
Communications and
Projects Manager at ANZUP
Over the past five years, there has been a dramatic shift in patients playing a more
active role in decision making and searching for more health information. Patients
and carers are also sharing their own experiences via online blogs, Twitter or
Facebook, and online patient communities.
People are now equipped, engaged and empowered, but education is key to
ensuring they get the most reputable information. So let’s start!
A LITTLE BELOW THE BELT 15
BELT 15
The journey
Top 10 Tips for Finding
Credible Information
1. The URL (web address) is a good signpost
to a site’s credibility. Sites that have an address
containing these elements will be reputable:
.gov Government sites
.edu University/medical school/educational institutions
.org Not-for-profit groups with a focus
on research
2. Identify, follow and source respected institutions
in the relevant field (we have some cancer sites
listed for you at the end of this article).
3. Seek out and check references and citations
(basis of the research and sources). Make sure
material is ‘evidence-based’.
4. If possible, look for any ‘declarations of interest’
in relation to the source of any financial assistance
towards the production of the information.
5. Always remember to discuss the information
you have found with your GP and medical
specialist.
Websites and
Hashtags of Note
l
l
l
l
l
l
l
l
l
http://www.anzup.org.au
http://www.cancer.org.au
http://www.prostate.org.au/
http://canceraustralia.gov.au
http://www.cancercouncil.com.au
http://www.cancervic.org.au/
http://www.kidney.org.au/
http://www.cancerinstitute.org.au/
http://www.mskcc.org
If you are an active Twitter user, there are also
Twitter chats that you can follow. Please view
this website to see what is available
http://www.symplur.com/healthcare-hashtags/
tweet-chats/
The following hashtags can also be followed
on Twitter and are a useful way to aggregate
particular interest areas:
#blcsm
6. Beware of websites selling cures or health
Bladder cancer
remedies.
7. Is there a privacy policy on the website?
Ensure there is a privacy policy in place if a
site requires you to register otherwise provide
personal information such as your name or e-mail
address, Also ensure your personal information
and anonymity are protected and are not being
provided or sold to other companies.
#tscsm
Testicular cancer
8. Check the ‘currency’ of the material: what is the
date of publication; is it the most recent version?
#PCSM
Prostate cancer
9. Never divulge personal information online such
as phone numbers, date of birth and addresses.
10. Be careful when and where you comment
on information. Google archives everything! Be
sure you are happy with what is said before you
“publish”. Always re-read what you write and ask
yourself if you will be happy with your comments in
the future.
16 A LITTLE BELOW THE BELT
#kcsm
Kidney cancer
ANZUP clinical trials
The technical explanation of a clinical trial is: to work out
the effect of some form of intervention on a group of
people with a defined condition. That is, each study is
designed to answer scientific questions and find new or
better ways to help patients with testicular, kidney, bladder
or prostate cancer.
The following examples provide an overview of a clinical
trial. Perhaps you have a new drug that you think is going
to work in cancer. You want to know how safe it is, how
often it works and how often it shrinks the cancer. Does it
make people live longer? Is it safe? Does it make them feel
better? And how does it stack up against the treatments
that are already used?
ANZUP has a strong record of successful clinical trials.
Many of the trials we do don’t involve big blockbuster
drugs. As an example, in testicular cancer, we did a
clinical trial that showed giving the same drugs one way
was better than giving them another way. It doesn’t
sound very interesting but think about it like this; - this
is a common cancer, these drugs don’t bring in large
amounts of revenue for the drug company, so they won’t
want to investigate the question. ANZUP did a clinical trial
comparing the two types of treatments and we proved that
one way was better than the other.
This is now the standard way this
treatment is given around the world
If you are a patient involved in a clinical trial, you are going
to receive new treatments not yet available elsewhere.
All patients who sign up to a clinical trial are carefully
monitored throughout the trial and followed up after the
trial. You would more than likely be in a trial that is being
carried out in major cancer centres throughout Australia
and New Zealand. Throughout your trial, the ANZUP
members (doctors, nurses, researchers, radiologists and
others specialising in urogenital and prostate cancers) will
pull their knowledge and expertise together to design and
monitor the trial.
How can I find out more about a trial?
Before you and your doctor make a decision about your
treatment (whether it is in a clinical trial or not), your type
of cancer will be diagnosed and ‘staged.’ Staging tells
how far the disease has spread. Deciding on treatment
depends on many things, including the stage of the
disease and your general health. You would most likely be
referred to a trial by your own doctor or by a doctor who
knows your case. Some patients find out about trials from
other sources. In any case, you must have a reasonable
understanding of your role in a research study and be
freely willing to take part in it.
Every clinical trial is designed to answer a set of research
questions. There are guidelines for each trial that
determine whether it is safe and suitable for you. Each
study enrols patients with certain types and stages of
cancer, and a certain health status. A study that involves
two or more treatments can only yield reliable answers
if all the patient cases are the same, so they can be
compared with each other.
When you see your doctor ask them “Is there a clinical
trial that might be suitable for me?” There may not be
one available, but if there is, it might be useful for your
treatment.
Your doctor will then go through all the information
related to that clinical trial; what it involves in terms of your
time, the tests that are done, how many visits to hospital,
the possible side effects of treatment and any other
relevant information you may require. If you agree, you will
be asked to sign a consent form. The consent form means
you have given permission for a drug to be used in a way
that it is not ordinarily used, or to use an experimental
drug. You would then take part in the clinical trial. If, at any
time, you want to come off the trial, you can. You are not
locked in.
There are many types of clinical trials. Some involve you
having to go to hospital and others can be taken at home
and you may have to visit the hospital just to make sure
everything is going well, and there have been no side
effects.
Other clinical trials don’t involve a treatment. Some of
the trials we are doing involve supportive care questions.
In other words, how well are people managing with their
diagnosis of cancer and how can we support people
better through the process of treatment and after
treatment? In this case, there may be very few visits to the
hospital. Some of these trials are done online or over the
phone.
A LITTLE BELOW THE BELT 17
Everyday Heroes
Community Fundraising for ANZUP
Fundraisers take many shapes and forms and they do it for so many reasons; loved ones, friends,
personal goals. Two of our most recent Everyday Heroes raising more than $10,000 between them
are featured below.
Belinda Jago (ANZUP CAP Chair) started Bec’s Troops in
memory of her daughter who died from kidney cancer
at the age of 19. Belinda said recently, "Fundraising for
ANZUP is all about clinical trial research to improve cancer
patient outcomes in bladder, testicular, kidney and prostate
cancer. Bec's Troops supports and advocates for this cancer
research in memory of Bec who fought her kidney cancer
for 5 years and was involved in a clinical trial during that
time” Belinda together with Bec’s family and friends, more
than 80 runners, took part in The Sunday Age City2Sea to
raise over $9,000 for ANZUP in 2014 ($12,000 in 2013).
This type of community fundraising raises critical funds but
more importantly, provides a positive way to raise awareness
about clinical trial research.
Charise Alcock participated in perhaps the most
picturesque of charity runs, the Knight Frank Pinnacle to
Point in Tasmania. The Knight Frank Point to Pinnacle
is a 21.4km run or walk from Hobart's iconic Wrest Point
Casino to the Pinnacle of the city's majestic Mount
Wellington. The course includes 1,270m of climbing and
provides an achievable challenge for all levels of athlete
from elite runners to recreational joggers and walkers.
Charise’s husband Nick recently participated in a clinical
trial in Tasmania, and this is what motivated her to raise
close to $1,000 for ANZUP.
Thank you
Love a good fun run, a serious run, swim, walk or ride?
Did you know ANZUP is now a registered
charity with the Sydney Half Marathon?
If you prefer a run to a ride or love them
both, did you know you can select ANZUP
Cancer Trials Group as the recipient of
your fundraising efforts in the Sydney Half
Marathon.
We would love to see as many ANZUP
members, donors; friends and family
challenge themselves and their friends
to raise funds during the Sydney Half
Marathon on Sunday 17 May
around beautiful Sydney Harbour.
Register here
http://www.smhhalfmarathon.com.au/
and select ANZUP as your
chosen charity.
Thank you and have a great
time.
Don’t forget to tweet @ANZUPtrials
or send us your photos!
18 A LITTLE BELOW THE BELT
Dr Ben Tran explains why initial
concept development is so
important to developing new
treatments in testicular, bladder,
kidney and prostate cancer.
ANZUP Q&A with Dr Ben Tran,
Medical Oncologist, Royal Melbourne Hospital
ANZUP:
Ben, we recently held a very successful fundraising
event, the Below the Belt Pedalthon. From this,
our riders, supporters and donors raised $222,000.
These funds are going to ANZUP to create new
concepts. What does a concept development mean?
Ben Tran:
Concept development involves taking an idea and
brainstorming in order to develop it into something
strong enough for a grant application. At the
present time we don’t have enough money to
independently fund our concepts or trials and rely
on grants.
There is a process to refine the idea/concept, detail
the objectives and study population. Essentially,
concept development involves considering if an
idea is good enough to take forward, and - if it is provide all the input necessary to take it forward.
Q: How might an ANZUP member come to think of a
new concept?
A: ANZUP members are intelligent and inquisitive
clinicians and health practitioners who encounter
problems in their clinical practice every day. A new
concept might simply arise from a clinician identifying
a problem in his/her practice that could be solved by a
clinical trial.
Q: What does it look like when ANZUP members
bring a concept to the table?
A: A short document, usually a one-pager, is generated
by ANZUP members. This would detail a title, objective
of the study and rationale behind the idea and possible
treatment outcomes.
Q: Who can bring an idea to the table?
A: Anyone with a concept can bring an idea to the
table, and this is one of the greatest values of being an
ANZUP member.
Q: Who says yes or no to the concept?
A: Concepts are generally discussed among a group
of experts, led by the chair of the particular subcommittee. After brainstorming the concept, it is up
to the committee to decide whether the concept has
enough merit to go ahead. By merit, I mean scientifically
interesting enough, potentially practice changing
and, most importantly, feasible.
A LITTLE BELOW THE BELT 19
Q: How does it progress from an idea to a pilot then
to a trial?
6.
A: 1. Presentation: A concept is presented by an ANZUP member to the relevant ANZUP subcommittee and other ANZUP members
7.Ethics: Ethics approves the protocol and trial
2.
Discussion: Group discusses the concept and
makes suggestions
3.
Endorsement: Group discusses the concept
and makes suggestions
4.
Letter of intent: A more detailed concept is
written as a letter of intent (this includes input from our Consumer Advisory Panel)
5.
Trial: A trial management committee is formed and a coordinating centre is appointed (either Clinical Trials Centre [CTC] or a Commercial Research Organisation
Research plan: A what, why and how research plan is submitted
8.
Protocol: The protocol is written
9.
Ethics approval: Ethics approves the protocol
and trial
1O.
Governance: Governance is established
11.
Trial opens: The trial is opened to patients
for recruitment
1
PRESENTATION
2
Input from
our Consumer
Advisory
Panel
4
LETTER
OF INTENT
7
ETHICS
20 A LITTLE BELOW THE BELT
3
ENDORSEMENT
DISCUSSION
8
PROTOCOL
5
TRIAL
9
ETHICS
APPROVAL
6
RESEARCH
PLAN
10
GOVERNANCE
11
TRIAL
OPENS
Funding wasn’t available
for the concept development
before the Pedalthon. These
meetings largely happened
via teleconference and each
participant volunteers their
time to be involved.
Q: What sources of funding would you look at in
each stage?
A: Funding wasn’t available for the concept
development before the Pedalthon. These meetings
largely happened via teleconference and each
participant volunteers their time to be involved.
Funding is required for the trial to go ahead, to pay
for drug trial management, per patient payments
etc… Generally, grants are written at the time of
concept is fully developed as a Letter of Intent (LOI).
focused on developing new and expensive
drugs. It has been the role of co-operative
groups such as ANZUP to conduct clinical trials
to answer clinically relevant questions that
don’t involve new drugs. Government money
is now scarce and conducting these studies is
becoming more difficult. Independent funding
is crucial to ensure we continue to ask clinical
questions that will help us better care for our
patients.
Q: What happens in a face to face meeting?
A: Concepts are discussed. The person bringing
the concept forward will give a short presentation
on the concept, including some background and
rationale. Committee members will ask questions
and diagrams/charts are drawn as the concept is
brainstormed. It is also easier to understand each
person’s perspective at a face to face meeting.
Q: What do you see as three possible
treatment changes that ANZUP could bring to
fruition in the next three years?
A: 1. Improve the treatment and prevention of
side effects in chemotherapy treated testicular
cancer.
2. Answer the question once and for all: what
is the best chemo regimen for muscle invasive
bladder cancer?
3. Determine if enzalutamide results in better
outcomes when given to castrate-sensitive
patients.
Q: Where might ANZUP members be coming
from for a face to face? For example, all over
Australia, or a particular centre, or anywhere
around the world?
A: Most ANZUP members are located within
Australia and come from both capital cities and
regional centres. Some ANZUP members also come
from New Zealand and other places around the
world such as the United States.
Q: Why does independent funding make a
difference to the progression of a concept from
concept to pilot?
A: Independent funding is crucial. In the current
financial climate, the pharmaceutical industry is
Ben is based in Melbourne at
The Royal Melbourne Hospital.
He is a specialist in medical oncology,
the DW Keir Research Fellow and the
ANZUP/Tolmar Research Fellow
He is also a clinician & translational
researcher in
l Urological cancers
l Drug Development
l Cancer Genomics/Molecular Profiling
A LITTLE BELOW THE BELT 21
Associate Professor Guy Toner,
ANZUP Deputy Chair provides an
overview of the recent Concept
Development Workshops.
The first Concept Development Workshops were held
following the Pedalthon fundraiser.
re-defining the concept with the help of newly identified
collaborators.
A new initiative for ANZUP in 2014 was the successful
introduction of two Concept Development Workshops
(CDW), recently held in Sydney. CDWs have been used
successfully by the ANZ Germ Cell (testicular and ovarian)
Trials Group (one of ANZUP’s forerunners) and other
cooperative trials groups to initiate and develop trial
concepts that subsequently resulted in successful and
important clinical trials. ANZUP has wanted to introduce
CDWs but has lacked the financial resources to do so
until this year.
3) An opportunity for the assembled group to brainstorm –
considering gaps in current knowledge and new opportunities
for studies.
There were three major components to these CDWs:
1) All members were invited to submit a brief concept
to be considered for discussion at the CDW. The aim is
to encourage members to consider new proposals and
submit an idea. This can be helpful for concepts that
require broad feedback or further refinement. Younger
members (trainees for example) can also find this process
rewarding.
2) Presentation of submitted concepts to a
multidisciplinary group at the CDW including senior
investigators, statisticians and before Clinical Trials Centre
(CTC) staff. The resulting discussion is often wide-ranging
but aims to define clear “next steps”, which might
include forming a working party to create a protocol or
At the start of the day we had
a couple of ideas. By the end
of the day we had 4-5 working
groups working up concepts to
take through the next steps then
through to funding
Professor Ian Davis
22 A LITTLE BELOW THE BELT
The CDWs are not intended to replace existing opportunities
to submit a concept to any of the sub-committees nor the
brain-storming sessions held at the Annual Scientific Meeting
(ASM). Rather, we hope that the CDWs will offer an additional
opportunity for concept development and encourage
participation from the breadth of our membership and also
foster multidisciplinary collaboration.
The first workshop was held on 5 November, with a prostate
cancer session in the morning and the afternoon devoted
to testicular cancer. The second workshop was held on 21
November and included sessions on bladder cancer and
kidney cancer.
ANZUP plans to hold future CDWs, hopefully as an annual
event. There are opportunities to expand the workshops, for
example by allowing a full day rather than half-day for each
type of cancer. Options to improve the workshop format will
be based on feedback from the membership after this year’s
inaugural events.
ANZUP wishes to acknowledge and thank the very
generous contribution of Mrs Ann Waterford.
Mrs Waterford has made an annual donation to ANZUP in
memory of her husband, Dr Waterford. This donation has
supported the inaugural bladder cancer CDW as well as
bringing ANZUP members to a bladder cancer meeting
immediately prior to this year’s Annual Scientific Meeting
in Melbourne.
It is only though the generosity of donors like Mrs
Waterford that ANZUP can support our members coming
together to work on concepts and ideas that will see us
improve treatments and outcomes for those affected by
bladder and other urogenital cancers.
Photo: Getty
The Inaugural
RIDING
FOR
UROGENIT AL
CANCERS
In 2014, ANZUP bit the major event bullet and we are so glad we did!
The Below the Belt Pedalthon, a four-hour ride to defeat our four cancers, was held on Tuesday, 16 September at
Sydney Motor Sport Park, Eastern Creek. It was a great example of sheer determination and absolute conviction
overriding inexperience and fear – not unlike the journey Pedalthon Founder Simon Clarke went through when first
diagnosed with testicular cancer.
We were both excited and terrified when Simon first approached ANZUP with his Pedalthon idea. We knew this could
be one way to speak directly to our key age groups affected by testicular, prostate, kidney and bladder cancer. We
wanted them to engage with Simon’s story and hoped they would support the ride and spread the word. In the first
few months, we hoped for a couple of sponsors and at best 20 teams providing 100 riders to raise an ambitious target
of $50,000. What we didn’t anticipate was the power of Simon’s story, the deep desire to help that it inspired and quite frankly - the level of commitment of the middle aged men and women in Lycra!
So how did we go?
35 teams
registered to ride,
including three
community teams.
248 riders took to the track
More than
$152,000
was raised by
individual
fundraisers
$100,000
197 completed the entire three
hours, plus the challenge races
through
sponsorship,
matched giving
and donations.
This money will go
directly towards
ANZUP research.
A LITTLE BELOW THE BELT 23
Simon was featured in the Australian Financial Review,
regional newspapers and on Studio 10 on Network 10. He
was interviewed on radio and our coverage on social media
rose rapidly.
Many of you reading this magazine will have felt the full
pain of those three hours on the track. We want to thank
you once again for your support and encourage you to keep
talking about clinical trials with your family and friends.
We met so many riders who shared their stories about family
members affected by these cancers. They shared stories of
heartbreak and inspiration, and their overwhelming desire
to raise funds for research that will change treatments and
outcomes. Simon and his family (mother Sally, sister Rose,
and brothers Will and Cam, along with his dad Andrew,
and his partner Louise) were the powerhouses behind the
Pedalthon. They called out to friends and businesses, they
donated and shared stories, and they were there on the day
to help Simon enjoy the magnificent event he had created.
Thanks to the Simon and the support of the teams and
corporations who gave so generously we have been able
bring the new ideas to the table and start the process of
developing new treatment concepts. We will continue with
Pedalthon in 2015. We will continue to tell our story, and
raise awareness, and hope that by doing so we will help
more people understand the importance of Australian
clinical trial research.
The success of an event such as Pedalthon belongs to
many. In particular, we wish to thank the many volunteers
who worked tirelessly for days and weeks to help us. To
everyone who gave up a day of work using annual leave,
or those who gave their free time to volunteer on the day,
we thank you! From the fabulous parking marshalls, to the
amazing supporters on the registration desk and the general
helpers and those who had the venue sparkling clean before
we left – thank you most sincerely.
Congratulations to the winning team, Custom Creative,
who rode the most number of laps on the day. To David
Cowling (Clayton Utz) and Jaidan Stevens, who were the
highest fundraisers. While Jaidan rode for the three hours,
he also raised more money for Pedalthon by having his 10year dreadlocks cut off. To Clayton Utz who had the highest
team fundraising effort and to all those who worked the
fundraising pages to achieve the magnificent total.
24 A LITTLE BELOW THE BELT
Above: Highest fundraising team Clayton Utz. Rolf Behrens, David Cowling,
Sonia Goumenis, Joshua Knuckey, Richard Mills, Peter Staciwa, Matthew Wilson.
Below: Simon Clarke, Jaidan Stevens and Jenny Sulicich as the first dread is cut off
RIDING
FOR
UROGENIT AL
CANCERS
The Results
Fundraising
Clayton Utz blew the fundraising off the track. Congratulations to David Cowling who raised $6,832 and the Clayton Utz team
who raised a phenomenal $19,730. Online individual fundraising stands at $153,168 (and growing). With donations, matched
funding and sponsorship Pedalthon will have raised net $222,000.
Overall team results
No. of laps Team Name
Team Time
Trials
219
210 205 201 179 175 175 165 159 157 153 153 150 147 146 143 141 139 133 13
128 127
121
111
108
101
95
91
89
87
79
78
36
35
1
2
3
4
SUBC
Custom Creative.com.au
The Origin Power Racers
Norton Rose Fulbright
Racers
Johnson Winter & Slattery
Fire & Rescue
New South Wales
Herbert Smith Freehills
Adrian Amer
International Towers Sydney
Allens
Pfizer Pedal Pushers
NSW POLICE
Baker & McKenzie
Gilbert and Tobin Lawyers
Cyclops #nochance
Origin Spokespeople
Tour De Rews
Clayton Utz
HasBeans
The Origin Power House
Sparke Helmore Lawyers
Herbert Smith Freehills
Mark Currell
Kemp Strang
Skid Marks
Pedal-Files
Beer Coasters
Custom Creative
Norton Rose Fulbright Racers
SUBC
Johnson Winter & Slattery
Origin The Origin Power Racers
RBS
Baker & McKenzie
Herbert Smith Freehills Mark Currell
Allens
Fire and Rescue New South Wales
Origin The Origin Power House
Sydney Markets Foundation
Clayton Utz
International Towers Sydney
Designcycle
Pfizer Pedal Pushers
Gilbert and Tobin Lawyers
Cyclops #nochance
Sparke Helmore Lawyers
Herbert Smith Freehills 2
Bank of America Merrill Lynch
Origin Spokespeople
Kemp Strang
Team Gresham
HasBeans
Beer Coasters
NSW POLICE
HPC Global
Congratulations to
K&L Gates
our inaugural Champions
and winners of the
ANZUP
BTB Pedalthon
Pedal-Files
Perpetual Trophy,
Specshots & Termimesh
Custom Creative.
Tour De Rews
Skid Marks
00:04:56.000
00:05:11.000
00:05:21.000
00:05:23.000
5
00:05:25.000
6
00:05:33.000
7
00:05:34.000
8 00:05:45.000
9 00:05:47.000
10 00:05:59.000
11 00:06:04.000
12 00:06:22.000
13 00:06:34.000
14 00:06:49.000
15 00:07:07.000
16 00:07:15.000
17 00:07:23.000
18 00:07:23.000
19 00:07:24.000
20 00:07:34.000
21 00:07:48.000
22
00:08:12.000
23 00:08:23.000
24 00:08:30.000
25 00:08:31.000
A LITTLE BELOW THE BELT 25
Thank you to our sponsors
Gold
sponsors
Silver
sponsor
As an ANZUP project manager and regular commuter cyclist I was
very excited to ride in the inaugural Below the Belt Pedalthon. In the
weeks and months leading up to the event I registered our team,
talked 4 work colleagues into riding with me and started fundraising.
However, as the big day drew closer I started to feel less sure of my
riding ability. Would the rest of the teams be made up of ‘proper’
cyclists with clip in shoes and scarily-defined calf muscles?
The atmosphere at the event briefing was electric and we couldn’t
wait to get out on the track. On the start line, the sound of hundreds
of shoes being clicked into cleats filled me with excitement and
adrenalin. We were off! After one slow lap (it wasn’t really that slow!)
it was time to put the pedal to the metal and race. By then the main
peloton was far in front of me but in the middle and back of the
pack the atmosphere was fun and friendly. We chatted to the other
teams and complained together that the ‘flat’ course was not nearly
as flat as we had been expecting. The hours flew by and our laps
mounted quickly. It was only in the last 30 minutes of the 3 hour
event that I started to feel really tired but by then I was determined
to finish the 16 laps (64km) I’d been aiming for. I finished my 16th
lap with just a minute or two to spare, coincidentally crossing
the line with the main peloton. Cruising into the pit lane I felt
sweaty and sore but also elated. The event had been an amazing
opportunity to challenge myself and to raise much-needed funds for
a cause close to my heart.
Now I am ‘in training’ for next year’s event. I can’t wait and I am
already window-shopping for some drop bars and clip in shoes of
my own!
Karen Bracken, Trial Project Manager, Clinical Trial Centre
Kit
sponsor
Colla
sponteral
sor
The Herbert Smith Freehills team enjoyed an awesome training ride
through the eastern suburbs beaches with Brad McGee in monsoon
conditions on 29 August. Brad’s climbing class was clear for all to
see through the famous cols of Vaucluse (Col de Water Tower)
and Dover Heights (Col de Military Rd). Flooding on the Coogee Malabar Road (and general softness in the HSF team) saw the ride
shortened in exchange for an extended breakfast. Over bacon and
eggs rolls and confit duck and hash browns (it was in the eastern
suburbs after all), Brad held the HSF team transfixed with tales from
his time as a pro in Europe. It was a fantastic morning enjoyed by
all. Brad gave generously of his time and was a gentleman - a true
credit to Australian cycling. Thank you BTB for organising - the
experience was worth the sponsorship money alone!
Mark Currell, Freehills from Ball-e-tin
We also received
unbelievable
support from
the NSWIS Road
Cycling Team –
Brad McGee OAM
and Ben Kersten.
They rode with our
sponsors and all
cyclists on the day.
Photo: Getty
26 A LITTLE BELOW THE BELT
Photo: Getty
Far left: Brad McGee OAM,
Margaret McJannett ANZUP EO,
Simon Clarke
Left: Ben Kersten and Simon Clarke
RIDING
FOR
UROGENIT AL
CANCERS
Ben rode two super laps with very generous
donations from Sydney Markets Foundation
($4,000) and Kemp Strang Lawyers ($500). We
are also truly grateful to Origin Energy who
quietly provided donations, teams and support
staff on the day.
We look forward to welcoming everyone to the
Below the Belt Pedalthon 2015 on Tuesday 1
September. We have tweaked the format a little
to offer plenty more opportunities for our keen
cyclists to race with patrons Brad and Ben.
We hope you enjoy a few photos from race day.
A LITTLE BELOW THE BELT 27
28 A LITTLE BELOW THE BELT
A LITTLE BELOW THE BELT 29
Simon Clarke
with his specialist
Dr Peter
Grimison
30 A LITTLE BELOW THE BELT
Ms Fiona Scott MP
representing
the PM
See you all at
BTB Pedalthon
Tuesday
1 September
2015
A LITTLE BELOW THE BELT 31
WHAT DOES A DONATION
LOOK LIKE?
We are so grateful to those who have already put their hands up for ANZUP.
We would also like to thank the many people who have made personal
donations directly to ANZUP. Your contributions are making a difference.
$50k - $250k
Kick off a
pilot study
Invest in a pilot
study to test the
feasibility of promising
drug therapies,
surgical methods,
postoperative care
and palliative care
options.
$10k - $500k
Give a grant
or fund a
scholarship
Inspire our culture of
research by providing
a grant or scholarship
to clinicians involved
in the care of patients
with urogenital and
prostate cancer.
$1m - $5m
Support a
clinical trial
Invest in a clinical
trial to test the
effectiveness, side
effects and best dose
of potential treatments
for urogenital cancers.
WOULD YOU LIKE TO HELP US?
Any donation to ANZUP over $2 is fully tax deductible. If you
would like to donate to ANZUP, you can donate through our
website www.anzup.org.au or by calling ANZUP on +61 2
9562 5033.
If you are interested in holding an event to support ANZUP
or are considering joining an event such as the City 2 Surf,
City 2 Sea, Sydney Marathon, Walk to Work Day or any other
community event, please let us know and we will help you
find the fundraising pages on GoFundraise and Everyday
Hero.
100% of every donation made to ANZUP goes towards
producing a clinical trial to improve the treatment of
bladder, kidney, testicular and prostate cancers.
DONATE NOW
32 A LITTLE BELOW THE BELT
Be kind in kind
Why in kind
makes a
difference?
Investment and support
can come in all shapes and
sizes. In kind donations
include providing the
budget for a specific staff
member, meeting room
use, auctionable goods
for fundraising, advertising
support and creative
support, and can help us
deliver more interesting &
educational information.
Current
ANZUP trials
If you would like to know more
about any of these trials please
discuss it with your GP or
specialist
Ask questions
Questions you may
consider if you participate
in a clinical trial
If you are thinking about taking part in
a clinical trial, here are some important
questions to ask:
l What is the purpose of the study?
l What does the study involve? What kinds of tests
and treatments? (Find out what is done and how
it is done)
l What is likely to happen to me with or without this
new research treatment? What could the cancer do
and what could this treatment do?
l What are my options and what are their advantages and disadvantages?
l Are there standard treatments for my case and
how does the study compare with them?
l How could the study affect my daily life?
l What side effects could I expect from the study?
(There can also be side effects from standard treatments and from the disease itself)
l How long will the study last? Will it require an extra time commitment on my part?
l Will I have to be hospitalised? If so, how often and
for how long?
l Will I have any costs? Will any of the treatment be free?
l If I am harmed as a result of the research, what
treatment would I receive?
l What type of long-term follow-up care is part
of the study?
A LITTLE BELOW THE BELT 33
Testicular Cancer/Germ Cell* Tumours
PHASE III Accelerated BEP Trial
The current standard practice for the treatment of germ
cell tumours is the use of the chemotherapy combination
called BEP, which consists of three chemotherapy agents
– Blemycin, Etoposide and Cisplatin – administered
on a 3-weekly cycle. BEP is given with a drug called
pegylated G-CSF (or pegfligrastim) that stimulates white
blood cell production.
The purpose of this study is to determine whether giving
the same dose of BEP on a 2 weekly schedule will be
more effective than a 3 weekly schedule and will be well
tolerated. The 2 weekly schedule is called “accelerated
BEP” and the 3 weekly schedule is called “standard
BEP”.
Up to 500 patients will be enrolled in the study in
Australia, New Zealand and other countries. To date 23
sites have been activated with another 6 ANZ sites in the
process of being activated.
This study is currently active and recruiting. If this is
something you or someone you know is interested in
please speak with your doctor.
For more information please go to the trials page on
the ANZUP website http://www.anzup.org.au/content.
aspx?page=trials-p3bep
All of the research, all of the
hard work, all the money that
has been spent up until that point
means nothing unless we can
close that loop. Unless we can
say we know this now, what does
that actually mean for improving
treatment for our patients because
it is only by closing that loop and
taking that final step that we actually
work out, “Are we doing things
better? Can we improve on what
we are doing?
Professor Ian Davis, ANZUP Chair
34 A LITTLE BELOW THE BELT
ANZUP collaborates with the University of Sydney through
the National Health and Medical Research Council Clinical
Trials Centre (NHMRC CTC).
Current site locations for the BCG+MMC
ANZUP Clinical Trial
ACT
• Canberra Hospital
NSW
• Calvary Mater Newcastle
• Concord Repatriation General Hospital
• Macquarie Cancer Clinical Trials
• Nepean Hospital
• Prince of Wales Hospital
• Royal North Shore Hospital
• Sydney Adventist Hospital
• The Tweed Hospital
• Westmead Hospital
QLD
• Icon Cancer Centre (HOCA Wesley)
• Princess Alexandra Hospital
• Royal Brisbane & Women’s Hospital
SA
• Royal Adelaide Hospital
TAS
• Royal Hobart Hospital
VIC
• Austin Health
• Box Hill (Eastern Health)
• Peter MacCallum Cancer Centre
• Royal Melbourne Hospital
*Germ Cells are the
cells in the body that
develop into sperm
or eggs
WA
• Royal Perth Hospital
NZ
• Christchurch Hospital
• Palmerston North Hospital
ANUP have been successfully awarded funding from the
Sydney Catalyst Translational Cancer Research Centre
for the Phase III Accelerated BEP translational sub-study.
This will involve the collection of blood and tissue from
participants for future correlative studies.
Current
ANZUP trials
Bladder Cancer
Bladder Cancer
BCG + MMC Trial
BL12
Non-muscle invasive bladder cancer is common and
causes substantial suffering. It requires removal or
irradiation of the bladder within 5 years in over 30%
of people with high risk tumours despite best current
treatment.
Urothelial cancer is a type of cancer which typically
occurs in the urinary system: the kidney, the bladder and
associated structures such as the ureters which connect
the kidneys to the bladder. A new treatment drug for
urothelial cancer is being studied called nab-paclitaxel
which will be compared with paclitaxel, which is a
chemotherapy drug that is most often used.
Recent preliminary studies show promising results
from adding MMC, a chemotherapy drug, to current
treatment with BCG. Medicines have to be approved
for use by Australia’s Therapeutic Goods Administration.
BCG is approved in Australia to treat bladder cancer.
MMC is approved in Australia as a treatment of early
bladder cancer. Before it is approved as a treatment for
early bladder cancer, it needs to be tested to see if it is
effective.
This randomised trial will determine the effects of adding
MMC on cure rates, survival, side effects and quality of
life.
It is anticipated that 500 patients will be enrolled in this
study in Australia and New Zealand. To date, 22 patients
have been recruited from 6 sites with an addition 6 other
sites in the process of being activated.
This study is currently active and recruiting. If this is
something you or someone you know is interested in
please speak with your doctor.
For more information please go to the trials page on
the ANZUP website http://www.anzup.org.au/content.
aspx?page=trials-bcgmmc
ANZUP collaborates with the University of Sydney
through the National Health and Medical Research
Council Clinical Trials Centre (NHMRC CTC).
Current site locations for the BCG+MMC ANZUP Clinical
Trial
This research is being done because we need to identify
more effective treatments for urothelial cancer that has
progressed after prior chemotherapy. Nab-paclitaxel is
a formulation of the chemotherapeutic drug paclitaxel
that is combined with a human protein called albumin.
Nab-paclitaxel has been tested in other cancers and has
shown promising activity in lung cancer, melanoma and
pancreatic cancer. Information from research suggests that
nab-paclitaxel may be a useful treatment for urothelial
cancer.
Nab-paclitaxel and paclitaxel are approved in Australia
to treat breast cancer and non-small cell lung cancer and
paclitaxel is also approved to treat ovarian cancer. Neither
of these two drugs is approved in Australia for use in
urothelial cancer.
The aim of the study is to see if nab-paclitaxel can improve
outcomes for patients with urothelial cancer that has now
progressed.
This study will be conducted in collaboration with the
NCIC Clinical Trials Group (NCIC CTG) in Canada. The
NCIC CTG is a non-profit research group. About 200
people from Canada, Australia and New Zealand will take
part in this study.
Approximately 100 participants from 27 Australian sites
will take part.
NSW
• Concord Repatriation General Hospital
• Northern Cancer Institute
At present, this study is in the startup phase, with the
study submitted for ethics approval and trials staff working
closely with the sites in preparation for study recruitment.
VIC
• Footscray Hospital
• Royal Melbourne Hospital
• The Alfred Hospital
This trial is in development
WA
• Fremantle Hospital and Health Service
ANZUP collaborates with the University of Sydney through
the National Health and Medical Research Council Clinical
Trials Centre (NHMRC CTC).
For more information please go to the trials page on the
ANZUP website www.anzup.org.au
A LITTLE BELOW THE BELT 35
Current
ANZUP trials
Prostate Cancer
ENZAMET
The treatment of metastatic prostate cancer (prostate
cancer that has spread beyond the prostate gland to other
parts of the body), starts with medications that manipulate
the hormone levels in the body. Hormonal manipulation
occurs in the form of injections called LHRHA (luteinizing
hormone releasing hormone analogues) and are often
combined with tablets called anti-androgens. These
treatments are generally used initially. However, men
with metastatic prostate cancer do develop resistance to
hormonal manipulation (i.e. so-called “castrate resistant
prostate cancer”) and are subsequently treated with
chemotherapy.
This study has been designed to assess a new antiandrogen tablet called Enzalutamide. Enzalutamide is much
stronger than older anti-androgens and has been shown to
improve outcomes for men with metastatic prostate cancer.
Recent clinical trials of the use of Enzalutamide in men
with castrate resistant prostate cancer and those who have
previously been treated with chemotherapy have shown
that Enzalutamide can decrease PSA levels and shrink or
stabilise cancer that has spread to other parts of the body
such as bones or lymph nodes. Further, quality of life for
men on Enzalutamide was significantly better.
The purpose of the ENZAMET trial is to find out if the
use of Enzalutamide earlier in the course of treatment for
metastatic prostate cancer, may be of more benefit in terms
of life expectancy and Quality of life compared to older
anti-androgens?
We do not yet know if Enzalutamide used in this way will be
helpful. The comparison arm is the current standard way of
using treatments. We have no reason at this stage to think
people will be disadvantaged if they receive that treatment,
as it is similar to what they would get if they were not on the
trial. Treatment will continue until the cancer starts to grow
or there is some other reason to stop treatment. All men
will continue to be followed up even after trial treatment
finishes.
ENZAMET will be an international trial run by ANZUP in
multiple centres in Australia, New Zealand, Canada, Ireland
and the UK. The aim is to have 1100 participants from
these countries. Participants will stay on the study drug
until there is evidence of progression and will be followed
for a minimum of 3 ½ years from entering the trial.
This study is currently active and recruiting. If this is
something you or someone you know is interested in please
speak with your doctor.
For more information please go to the trials page on
the ANZUP website http://www.anzup.org.au/content.
aspx?page=trials-enzamet
36 A LITTLE BELOW THE BELT
ANZUP collaborates with the University of Sydney through
the National Health and Medical Research Council Clinical
Trials Centre (NHMRC CTC).
To date, 29 sites have been activated with another 9
ANZ sites in the process of being activated. 72 patients
recruited to date. We have started submission to ethics
and regulatory bodies in Europe lead by the collaborative
group, Ireland Cooperative Oncology Research Group
(ICORG).
NSW
• Central West Cancer Services
• Chris O'Brien Lifehouse
• Concord Cancer Centre
• Nepean Cancer Care Centre
• Northern Cancer Institute
• Port Macquarie Base Hospital - NCCI
• Prince of Wales Hospital
• Riverina Cancer Centre
• St George Hospital
• St Vincent's Hospital Sydney
• Sydney Adventist Hospital
• Wollongong Hospital
QLD
• Gold Coast Hospital
• Nambour General Hospital
• Princess Alexandra Hospital Brisbane
SA
• Ashford Cancer Centre
• Flinders Medical Centre
• Royal Adelaide Hospital
TAS
• Royal Hobart Hospital
VIC
• Austin Hospital
• Australian Urology Associates
• Box Hill (Eastern Health)
• Goulburn Valley Health
• Monash Cancer Centre - Moorabbin
• Peninsula South Eastern Haematology
& Oncology Group (PSEHOG)
• Peter MacCallum Cancer Centre - East Melbourne
• St Vincent's Hospital Melbourne
WA
• Royal Perth Hospital
NT
• Royal Darwin Hospital
Prostate Cancer
ENZARAD
Prostate cancer is often treated with powerful X-rays
(radiotherapy) instead of surgery. The reasons for
choosing radiotherapy or surgery are complex and this
is a discussion that men should have with their treating
doctors. We will specifically look at men whose cancers
have higher risks of coming back after treatment but
have not shown any evidence yet of spread outside
the prostate. In this situation we are aiming for a
cure if possible and the evidence shows that this
is more likely when radiotherapy is combined with
hormone treatment. This treatment is called Androgen
Deprivation Therapy (ADT). ADT is often in the form of
injections called LHRHA (luteinizing hormone releasing
hormone analogues) and often combined with tablets
called anti-androgens. Enzalutamide is a new and
stronger anti-androgen that has also been shown to
work against prostate cancers that are resistant to
other antiandrogens.
This is not an alternative treatment to radical
prostatectomy. If you are offered a radical
prostatectomy you will not be eligible for this trial.
ENZARAD is a clinical trial for men with this type of
prostate cancer where a decision has been made that
radiotherapy is the best treatment. That is this trial
is for those men who cannot or are not suitable for
radical prostatectomy due to their pathology or core
morbidities. ENZARAD will answer this question: will
men with prostate cancer apparently confined to the
prostate but at high risk of coming back elsewhere
benefit, in terms of living longer, from adding
Enzalutamide to radiotherapy plus ADT?
Clinical trials are the evidence
that drive clinical practice. Our
trials are run by investigators
to answer important clinical
questions in terms of improving
outcomes for our patients with
urological cancers.
Associate Professor Guy Toner,
ANZUP Deputy Chair
ENZARAD will be an international trial run by
ANZUP in multiple centres in Australia, New
Zealand, Canada, Ireland and the UK. The aim
is to have 800 participants from these countries.
Participants will stay on study drug until there is
evidence of progression and will be followed for a
minimum of 3 ½ years from entering the trial.
This study is currently active and recruiting. If this is
something you or someone you know is interested
in please speak with your doctor.
For more information please go to the trials page
on the ANZUP website http://www.anzup.org.au/
content.aspx?page=trials-enzarad
This trial is conducted in collaboration with All
Ireland Cooperative Cancer Research Group
(ICORG) and the Trans Tasman Radiation Oncology
Group (TROG).
To date, 14 sites have been activated with 27
patients have been recruited. An additional 11 ANZ
sites in the process of being activated. We have
started submission to ethics and regulatory bodies
in Europe lead by the collaborative group, Ireland
Cooperative Oncology Research Group (ICORG).
NSW
• Calvary Mater Newcastle
• Campbelltown Hospital
• Central West Cancer Services
• Chris O'Brien Lifehouse
• Liverpool Hospital
• Westmead Hospital
QLD
• Mater Adult Hospital Radiation Oncology Services
• Princess Alexandra Hospital Brisbane
• Royal Brisbane & Womens hospital
TAS
• Royal Hobart Hospital
VIC
• Box Hill (Eastern Health)
• Peter MacCallum Cancer Centre
(East Melbourne)
• Peter MacCallum Cancer Centre
(Moorabbin Campus)
A LITTLE BELOW THE BELT 37
Prostate Cancer
RAVES Trial
Radical prostatectomy is the most common curative
approach offered to men with newly-diagnosed
prostate cancer. Unfortunately, up to half of these
patients will have factors placing them at high risk
of cancer reoccurring. Having radiotherapy after an
operation is known to improve care rates but what is
not known is whether it should be given immediately
after the operation or only if PSA rises after surgery
– indicating active cancer. Immediate radiotherapy
may not benefit all men and can cause serious side
effects such as bladder problems and impotence.
International lack of consensus on the optimal timing
of radiotherapy has resulted in varied clinical practice.
This Trans Tasman Radiation Oncology Group (TROG)
led Phase III trial will compare the two approaches.
If radiotherapy at recurrence results in equivalent
outcomes and improved quality of life, it would
become the standard treatment.
A total of 470 men from Australia and New Zealand
will participate.
• Peter MacCallum Cancer Centre
QLD
• Mater Centre
• Premion
• Princess Alexandra Hospital
• Toowoomba Cancer Research Centre
• Townsville Hospital
• Royal Brisbane & Women’s Hospital
WA
• Perth Radiation Oncology Centre
• Royal Perth Hospital
• Sir Charles Gairdner Hospital
NZ
• Auckland Hospital
• Auckland Radiation Oncology
• Christchurch Hospital
• Dunedin Hospital
• Palmerston North Hospital
• Waikato Hospital
• Wellington Hospital
This study is currently active and recruiting. If this is
something you or someone you know is interested in
please speak with your doctor.
For more information please go to the trials page on
the ANZUP website
Recruiting sites
NSW
• Calvary Mater Newcastle
• Campbelltown Hospital
• Central West Cancer Services
• Nepean Hospital
• Port Macquarie Base Hospital
• Riverina Cancer Care Centre
• Royal North Shore Hospital
• Royal Prince Alfred Hospital
• St George Hospital
• St Vincent’s Hospital Sydney
• Westmead Hospital
VIC
• The William Buckland Radiotherapy Centre
The Alfred
• Austin Hospital
38 A LITTLE BELOW THE BELT
Many people when
confronted with a clinical trial
for the first time, may think
they are being treated as a
guinea pig, but all the evidence
shows that people who are
participating in clinical trials
are receiving the best level of
clinical care and have in general
better outcomes than those
who are not participating.
Associate Professor Guy Toner,
ANZUP Deputy Chair
Current
ANZUP trials
Prostate Cancer
ClinTrial App
Living Well with Prostate Cancer
In July 2014 ANZUP released its first trial based App. This application was designed for the specialists but
will also be a very useful tool for consumers. If you are
looking for a trial for your particular cancer you can refer
to either the ANZUP website or the new ClinTrial Refer.
Prostate cancer is the most common male cancer
in developed countries. There are approximately
22,000 men living with advanced prostate cancer
today. Research into the impact of advance prostate
cancers shows that men report higher levels of
psychological distress, poorer quality of life and have
an increased risk of suicide compared to men with
localised disease. Additionally, many men report
they do not receive enough support after their
diagnosis. This project is trialling a professionallyled telephone session delivering mindfulness-based
cognitive therapy group intervention for men with
advance prostate cancer.
This program is designed to assist men with stress
management and improve their psychological
wellbeing. Its effectiveness will be compared to an
educational program consisting of the best available
resources for men with advanced prostate cancer.
This trial is active and recruiting until the end of 2014.
If this is something you or someone you know is
interested in please speak with your doctor.
ANZUP collaborates with Griffith University and
Cancer Council Queensland.
The ClinTrial Refer ANZUP app
provides a current list of all ANZUP and ANZUP
co-badged clinical research
trials conducted in cancer
centres in Australia and
New Zealand.
Designed for oncologists,
general practitioners,
research unit staff and
patients, ClinTrial Refer
ANZUP has searchable
clinical research trial
details, hospital locations
and contacts, and
inclusion and exclusion
criteria.
We hope this will help
the community to identify
trials that might be
suitable.
To download the free app, please visit:
ANZUP really values the
involvement of consumers in
clinical trials. The reason for
that is that while we may think
it is important to do a clinical
trial, really it is the consumer
who has the best judgement
about the importance of the
clinical trial.
• Apple iTunes: https://itunes.apple.com/au/app/
clintrial-refer-anzup/id894317413?mt=8
• Google Play: https://play.google.com/store/apps/
details?id=com.lps.anzup
Or go to the App/Android store and type in ANZUP
Associate Professor Guy Toner,
ANZUP Deputy Chair
A LITTLE BELOW THE BELT 39
BY WAY OF DEFINITION
Each magazine, we will be exploring a few terms that you may
have come across regarding clinical trials.
What is a clinical trial?
The information below is provided on the
National Health and Medical Research Council
website www.australianclinicaltrials.gov.au.
Information was accessed 23 January, 2014.
Clinical trials are research investigations in
which people volunteer to test new treatments,
interventions or tests as a means to prevent,
detect, treat or manage various diseases or medical
conditions. Some investigations look at how people
respond to a new intervention and what side
effects might occur. This helps determine if a new
intervention works, if it is safe, and if it is better
than the interventions that are already available.
Clinical trials might also compare existing
interventions, test new ways to use or combine
existing interventions or observe how people
respond to other factors that might affect their
health (such as dietary changes).
The World Health Organization (WHO)
definition for a clinical trial is:
Clinical trial interventions include but
are not restricted to:
• experimental drugs
• cells and other biological products
Any research study that
prospectively assigns human
participants or groups of humans
to one or more health-related
interventions to evaluate the
effects on health outcomes.
40 A LITTLE BELOW THE BELT
• vaccines
• medical devices
• surgical and other medical treatments
and procedures
• psychotherapeutic and behavioural therapies
• health service changes
• preventive care strategies
• educational interventions
Researchers may also conduct clinical trials to
evaluate diagnostic or screening tests and new
ways to detect and treat disease.
What does translational mean?
Dr Peter Grimison explains
“This activity aims to facilitate a “personalised
medicine” approach to the treatment of
individuals with advanced testicular cancer. We
want to determine whether a person’s genetic
make-up can tell us reasons why 100% of
individuals with advanced testicular cancer are
not curable with best standard chemotherapy.
We will try and identify genetic variants within
an individual that alter how a person’s body
processes chemotherapy, and genetic variants
within testicular cancer that make it inherently
resistant to standard chemotherapy. Results
could lead to the design of tailored treatments
for such individuals, for example treatments that
incorporate a higher dose of or an
alternative form of chemotherapy.
We will also establish the first national biobank
for advanced testicular cancer, which can
be used in future collaborative international
research.
Our ultimate goal is to try and cure 100% of
patients with testicular cancer.”
DEFINITIONS
Blinded Trial
Off-Label Use
A blinded clinical trial is one where the participants are
not told which treatment they are receiving.
Off-label use occurs when a drug is prescribed for
conditions not approved by the Therapeutics Goods
Administration (TGA).
Clinical Trial
A clinical trial is a scientific and medical study using human subjects to test the safety and benefit of new drugs
or medical treatments.
Phase I Clinical Trials
Phase I clinical trials are initial studies using a small test
group to see if a drug is safe for use in humans.
Control Group
Phase II Clinical Trials
In clinical trials, the control group is given a standard
treatment (or placebo), which is a different treatment
given to the test group, in order to compare the results
of the two.
Phase II clinical trials are secondary studies that evaluate
the efficacy of drugs and their side effects on humans.
Double Blind
A double blind clinical trial is one where both the participants and the investigators of the trial do not know
which participants are receiving which treatment.
Dose Finding Study
Clinical trial where different doses of drugs are given
to different groups of participants to determine which
dose is most beneficial.
Efficacy
Efficacy is the ability to produce results. In cancer clinical
trials, it means the ability of the treatment being tested
to control or eradicate a cancer, or to help someone feel
better or liver longer.
Phase III Clinical Trials
Phase III clinical trials are expanded clinical trials usually
involving a large number of participants often across
many facilities or locations. Phase III testing looks at
the benefit/risk relationship of new medications. They
often study whether the new drug is better than current
treatments.
Phase IV Clinical Trials
Phase IV clinical trials are when drugs that have been
approved for sale to the general public, either over the
counter or by prescription, are continually studied in a
larger population for rare or unexpected side effects.
Placebo
A placebo is an ineffective treatment given in clinical
trials to compare to a new medication.
Ethics Committee
Placebo Effect
An institutional review board is made up of physicians,
medical personnel, community advocates, and others. It
is their job to ensure that participants in clinical trials are
protected and being treated ethically.
The placebo effect describes physical or emotional
changes a clinical trial participant experiences based
on their expectations, and not because they have been
given a new medication.
Exclusion criteria
Preclinical Testing
Criteria that will make a potential participant ineligible
to participate in a clinical trial. This might include age,
overall health, and abnormal kidney or liver function.
Preclinical testing is testing done prior to clinical trials
and prior to any testing on humans. It usually involves
research and testing on animals or cells.
Inclusion criteria
Randomised
Inclusion criteria are the criteria that participants must
meet in order to qualify for participation in a clinical
trial. This might include type of cancer, extent of the
disease, and former treatments received.
Randomised clinical trials are when participants are chosen at random to receive different treatments so that
the effects of each can be compared.
Informed consent
Informed consent is the process for clinical trials participants to be made aware of all aspects of what they
can expect during the clinical study before deciding
whether to participate. This includes treatments, time
and travel commitments and potential risks. Participants
must sign a document confirming their consent.
Recruiting
Recruiting refers to the phase of a clinical trial where
participants are screened for eligibility and invited to
participate.
Side effects
Side effects are unwanted, often negative results of a
treatment.
A LITTLE BELOW THE BELT 41
The National Health and
Medical Research Council
defines the phases
of trials as:
PHASE I
clinical trials are
done to test a
new biomedical
intervention for the
first time in a small
group of people
(20-80) to evaluate
safety (e.g. to
determine a safe
dosage range and
identify side effects).
42 A LITTLE BELOW THE BELT
PHASE II
clinical trials are
done to study an
intervention in a larger
group of people
(several hundred) to
determine efficacy
(whether it works
as intended) and to
further evaluate its
safety.
PHASE III
studies are done to
study the efficacy
of an intervention in
large groups of trial
participants (from
several hundred to
several thousand)
by comparing
the intervention
to other standard
or experimental
interventions (or to
non-interventional
standard care) as well
as to monitor adverse
effects and to collect
information that will
allow the intervention
to be used safely.
PHASE
ll lll lV
PHASE
l
PHASE
PHASE
INCREASING
SIZE AND COST
PHASE IV
studies are done
after an intervention
has been marketed.
These studies are
designed to monitor
the effectiveness
of the approved
intervention in the
general population
and to collect
information about
any adverse effects
associated with
widespread use over
longer periods of
time.
ANZUP welcomes
as the official travel Partner
Members of ANZUP in New Zealand will
be pleased to hear their travel costs will be
supported by a new relationship with
Air New Zealand.
In an agreement recently announced, Air New
Zealand will provide a number (10) of return
economy airfares between New Zealand and
Australia. This partnership will provide ANZUP
with a significant cost saving and will enable
members to travel for face-to-face meetings in
Australia.
ANZUP Board Member and Chair of the
Fundraising and Promotions sub-committee
Joe Esposito said recently “this type of in-kind
support helps us meet our goals while reducing
the costs otherwise associated with these
meetings”.
Executive Officer Margaret McJannett said,
“This is the start of what we hope will be a longterm partnership with Air New Zealand. Travel
costs for the ASM and face-to-face meetings
are significant and having access to this kind
of travel support allows us to bring our NZ
members across so they can participate in our
research activities helps our bottom line while
also helping us progress trial concepts. ”.
The partnership is in place for twelve months
and we look forward to continued discussions
with Air New Zealand regarding subsequent
years.
Medical Oncologist, Dr Nicola Lawrence from
Auckland was able to attend the recent concept
development workshop for bladder and renal
cancer through the generous sponsorship provided
by Air New Zealand.
If you are travelling for business or pleasure to NZ
or the US we ask you to keep Air New Zealand’s
support in mind when booking your fares.
ANZUP wishes to thank
our corporate supporters for 2014
A LITTLE BELOW THE BELT 43
IN THIS FIGHT
THERE ARE NO
RULES.
Hear from ANZUP's experts about your below
the belt cancer and the latest clinical trials
available to you.
Sunday 12 July 2015. Sofitel Sydney Wentworth. Free entry but bookings essential. www.anzup.org.au
FIGHT CANCER
BELOW THE BELT
• TESTICULAR • PROSTATE • BLADDER • KIDNEY •
44 A LITTLE BELOW THE BELT

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