Conducting clinical trial research to improve the treatment of bladder, kidney, testicular & prostate

64 Pages·2015·6.3 MB·English

A little below
the belt
Conducting clinical trial research to improve the treatment
of bladder, kidney, testicular & prostate cancer
an anzup cancer trials group publication issue 4, December 2015
2 a little beloW tHe belt
Welcome
Welcome to the third issue of the ANZUP Cancer Trials Group
consumer magazine A Little Below the Belt. In this issue, exceptional
patients share their experience as we explore opportunities available
for regional and remote patients to participate in a clinical trial. At the
same time we examine some of the unique issues those patients face
What’s inside
compared with their city counterparts.
We also meet Dr Craig Underhill, a medical oncologist from Albury-
Wodonga. Craig is a champion of rural and remote patients, driving
their agenda and special needs at a local, state and national level. 04 ANZUP Chair Ian Davis
We continue to follow the journey taken by our patients and their 0W6 Thhe aANtZU’sP CiAnP side
families as they navigate the health system after a cancer diagnosis.
We also look at a new ANZUP trial that has just received first round
08 My Experience on the CAP
funding: The Pain Free TRUS B trial, created by Dr Jeremy Grummet, 03 Welcome
aims to reduce the pain and anxiety felt by men undergoing a
prostate biopsy. Jeremy also outlines his own journey in taking an 1004 CMoensssuamgee rf rToemst itnhge tCheh aPirICF
emerging idea through to a fully developed concept, as well as the
1026 TOhbei tJuoaurryney - Being on an ANZUP clinical trial
challenges he faced when his initial request for funding was declined.
Colin O’Brien is a prostate cancer survivor and a member of the 1047 TMhees Jsoaguren feryo m- T thhee OCnAeP SCthoapi rShop
ANZUPP eCodnsuamelrt Ahdviosorny P anreil.d Hee harss w osrkepd colostelty weithd 08 Rural health & overview - Dr Craig Underhill
Jeremy in developing the concept from the perspective of the 15 The Journey - The doctor’s perspective -
patient. Colin explains how he plays devil’s advocate on the potential 09 IBmrmianu nCoothoeprearp EyNZARAD trial patient
everywhere!
trial by putting himself in the patient’s shoes. 10 Steven Trigwell BCG MMC trial patient
16 What is Cancer Immunotherapy
In July each year, ANZUP hosts an Annual Scientific Conference for 11 From an idea to a trial
its mOemubre rBs aenldo mwe mthbeer sB oef tlht eP peudblaicl. t hA ofrene wpuabsli ca fonroumth weilrl be
held on Sunday, 11 July at the Wentworth Sofitel Sydney from 1pm- 1182 TDhaen Jieolu Tronbeiya s- C- tliensitciaclu Rlaers ceaanrcche rManager’s
hugely successful event and fundraiser.
4pm. World leading specialists in urogenital and prostate cancers perspective
15 Telehealth - a revolution in healthcare
will dOiscnuses tfhreie lantedst otref aAtmNenZtsU aPnd s cplinoictatle trdia lts.h Aisll Larieo wne lCcoom.e
to attreidnde, ra nind wteh een cSoyudrangee yyo uC tBo Dsha lroe nthgis ianffotremra ttiohne w ritihd yeo.u r 2108 TFhuen dJorauisrninegy c–h Taemstpiciounlasr Cancer
family and friends. More information can be found on the ANZUP
websWitee, hjtutps:t// wlowvwe.adnz uopu.orr gj.eaurseys this year. Thanks to 2119 CSoeraprcohraintge Sfopro cnresodrisb laen hde Ianl-tKhi nindfo Srumpaptoiornters
We aolsuo rlo sopk foonrwsaordr sto Gintrreodsuhcainmg y oaun tdo ATnhneo Wmaslloingnt oGn.e Aennr e 2220 TCreuarrtemnet nAt NfoZrU aPd vtraianlcsed prostate cancer
has bLeaewn ay leonrsg -tfiomre hsueplppoirntegr o uf AsN aZcUhP iaenvde ru onsu arn nguoalalyl isn. the 26 Current ANZUP innovatons
City2Sea and other community events in memory of ANZUP CAP
25 Current ANZUP Trials
Chair Belinda Jago’s daughter, Bec. 27 Ask the doctor
Testicular cancer is rarely funny. That said, we meet Melbourne actor 3288 BBeellooww tthhee BBeelltt PPeeddaalltthhoonn 2015
and comedian Daniel Tobias who has managed to put a comedic
spin on something that affects too many young Australian men in
their prime. Daniel was diagnosed with testicular cancer just about
the time that girls started to take an interest in him. A harrowing
regimen of chemo and a subsequent orchiectomy provided the AANNZZUUPP CCaanncceerr TTrriiaallss GGrroouupp
foundation for a hugely successful stage show of which he is both LLeevveell 66,, LLiiffeehhoouussee BBuuiillddiinngg
writer and producer. The Orchid and the Crow is an hilarious and
111199--114433 MMiisssseennddeenn RRooaadd
poignant musical and theatrical exploration of his journey into and
CCAAMMPPEERRDDOOWWNN NNSSWW 22005500
out of testicular cancer. It sounds an unlikely subject, but Daniel’s
show is so successful he is about to do a 26-show season at the
Edinburgh Fringe Festival.
LLoocckkeedd BBaagg 7777
ANZUP members and supporters work tirelessly to identify new and CCAAMMPPEERRDDOOWWNN
Watch the video
better treatments for patients affected by testicular, prostate, kidney
NNSSWW 11445500
and bladder cancer. However, we know cancer is cruel and, despite
our very best efforts, takes those we love. In the past six months,
ANZUP has said goodbye to two towers of our Consumer Advisory
Panel: Matthew Carr and Ian Roos OAM. We wish to acknowledge PPhhoonnee
their enormous contribution as patient advocates and salute their
++6611 22 99556622 55003333
bravery. Rest in peace with our thanks for your courage and support.
Without the generosity of our patients, their families, friends, and
carers, ANZUP would not be able to develop improved treatments.
We need to hear your stories to help others understand the EEmmaaiill
importance of clinical trial research in making real and substantial
aannzzuupp@@aannzzuupp..oorrgg..aauu
changes to patient outcomes. Please let us know if you know
someone whose story should be told. The contact details for ANZUP
are just to the left of this story.
We thank and acknowledge AstraZeneca
We wish to thank all our contributors to this issue. Their time and
commitmfeonrt itsh veeirry i nmvuaclhu aapbplere csiuaptepdo.rt in 2015 in TTwwiitttteerr
ensuring the dissemination of ANZUP’s @@AANNZZUUPPttrriiaallss
We hope you enjoy this issue of A Little Below the Belt. Don’t forget
to look oucto fonrs uusm oenrli nme,a agnadz tiankee “aA m loitmtleen tb teol orewad t hthero bueglht ”th. e
ANZUP website for all the latest news and trial information.
GPurabplishhice dd ebsyig AnN: gZeUoPr gCieagncireldr eTsriigalnss G@riocluopu dLt.cdo. m
Copyright. Editor Liz Thorp
Graphic design by Gen Spilsbury A LITTLE BELOW THE BELT 3
A LITTLE BELOW THE BELT 3
anzup who are we
& what do we do
By the Chair of ANZUP, Professor Ian Davis
Welcome to this edition of “A little below the belt,”
the magazine produced by ANZUP aimed specifically
for the general community!
We are here to improve outcomes for people and their a range of organisations including the pharmaceutical or
families affected by cancers of the urinary system (prostate, other health care industry partners, other groups like ours
kidney, bladder and testicles). these cancers affect large elsewhere in australia and new zealand or around the
numbers of people in australia; not only those who have world, or with the community or professional organisations.
the cancer but also all of those around them. anzup is this puts us in a very unique place.
the australian and new zealand urogenital and prostate
cancer trials group. anzup aims to improve outcomes there are many other organisations working in the area
for anyone affected by these cancers. We do so by of cancer, and many of them are involved in raising the
doing clinical trials so that we can understand these profile of their cancers of interest or in raising funds for
cancers better, work out better ways of treating them and various initiatives. We applaud them and support them
supporting people, and change clinical practice for the whenever we can. anzup has a key point of distinction:
better in australia, new zealand and around the world. we are actually doing the clinical trials that answer the
our members are people involved in the care of people key questions. clinical trials are the way to obtain the
with these cancers and who do research into them. information and evidence we need to improve what we
We come from a wide range of places, professions do and improve the outcomes for our patients. all types
and experiences but all with the same goal: we need to of research are important and need to be supported, but
make a difference. without the clinical trials to tell us whether we are doing
any good, then we would just be working blindly.
the sorts of trials we do are just as varied. When people
think of clinical trials, they think of a new drug compared to clinical trials are hard work and not just for the people
an old drug. We do those sorts of trials but we also do far who take part in them! they often involve large numbers
more than that. We look at all types of cancer treatment: of people working behind the scenes, to ensure the science
not just drug treatment, but surgery, radiation treatment, is strong, the research is ethical, the research questions are
hormone treatment, immune treatments, psychology and important, the trial is well-designed and can answer those
supportive care, information needs and others. We try important questions, the people taking part are looked
wherever possible to “add value” to these clinical trials by after with the highest quality of care, the information we
linking in other experts: the lab scientists, the public health generate is clear, the results are communicated effectively
experts, the health economists and again many others. to all stakeholders (that means you!), and that practice does
We are not restricted to using a treatment developed by indeed change and improve. it takes time, lots of it; money,
just one company; we are able to work with and between lots of it; and patience, and i think you know where this is
4 a little beloW tHe belt
heading. there is no cutting of corners, though: if we tried to encourage you to look at all of these things and to
do that, then the whole process is compromised and wasted. consider talking to your treating doctors about whether
it is a great privilege to be part of this and to work with so a clinical trial might be appropriate for you.
many people dedicated to the same goal. i am immensely
proud of what we all collectively do and humbled at the Once again this edition of the newsletter is overflowing
generosity of everyone who contributes their time, energy with interest. You will hear about how the consumer
and resources. advisory panel works with anzup. We have some stories
from people who are involved in our trials, and we would
We are also looking to the future. every time we do a trial love to hear from you as well. the stories continue with
we know that there will always be more questions to be contributions from nurses or trial coordinators involved
answered, so we need to plan for what the next trials will in running the clinical trials. this edition has some
be even before the first one has finished. ANZUP has robust information on treating cancers by boosting the immune
processes to “scan the horizon” for what will be coming system including the “ron Walker” treatment, something
up and to develop new trial concepts to answer those of great interest to us and i am sure to many of you. We
questions. We run concept Development Workshops to have information on some great initiatives in bladder and
fast-track the development of trial ideas. We have an annual prostate cancer; advice on where to find good health
scientific meeting where we share information and expertise information and how to understand it; details of our trials;
in a fantastic atmosphere of collaboration and friendship. and some of the fundraising activities we undertake to
the meeting also includes a community engagement forum try to support our work, including stories from some of
that is a great opportunity for the general community to the key participants in our below the belt pedalthon held
learn more about these cancers, clinical trials and specifically in september. see if you can spot the one most likely to
about what we do. We have a masterclass at this meeting bring home a gold medal from rio next year!
where we run an intensive educational program aimed
mainly at trainees, nurses and allied health professionals ANZUP is a not-for-profit charity registered in Australia
although we often find many senior people attending as and New Zealand. We must find the financial resources
well. this year we ran a very intense “preceptorship” course for every trial we do: we do not have any reliable funding
in prostate cancer again aimed at people early in their sources to do the actual trials. We have to compete for
careers. We are very conscious that we need to foster and grant funding or other sources of funding and this is
grow the next generation of clinician-researchers because sloooowww and very unreliable, especially when the rate
the work will never stop until these diseases are finally of successful grant funding this year from nHmrc is at
eradicated. its lowest level ever and only likely to get worse. You can
help by contributing to our fundraising activities, and
anzup has great connections with other key groups there are many ways to do so: not only by donating, but
including other cooperative trials groups, community and also by participating in our events, raising our profile in
advocacy groups and various professional bodies. We have the community, showing where we are distinct (we do the
valuable support from cancer australia and also in recent trials!), and demanding that more resources be provided
years from cancer institute nsW. We have links with industry to do this important work. You will find information in here
but not in such a way that we lose our autonomy and about how you can help, or you can visit our website.
independence. We also have very strong connections to the
broader community and are very conscious that ultimately You are most likely reading this because these cancers
we must answer to you. our consumer advisory panel gives have already touched you or your family in some way,
us great advice and guidance to help us in all these areas. as they do for so many people. You understand how
important it is that we do better, and the only way to
i hope you enjoy this newsletter. it is just one of the ways that make a difference is to show the evidence that things can
we promote what it is we do and how we do it. You can also be done better. that is what clinical trials are for. that is
get more information from our website (www.anzup.org.au). why we must keep talking about all this and why the work
the anzup clintrials refer app is generally available for must go on. that is why we are here.
mobile devices and will tell you what trials are running,
what they are about and where they are open. We certainly thanks for your interest in anzup.
Did you know anzup is now tweeting
to more than 1000 followers?
our community is sharing trial updates and news across the twitter
network. We are always interested in retweeting your thoughts, stories
and insights. at our asm in July, #anzup15 threads made more than
1.2 million impressions in four days. Follow @ANZUPtrials and start
communicating with leading professionals today.
a little beloW tHe belt 5
the anzup cap
scientific meeting and attended by some of the world’s leading
experts in urogenital and prostate cancer clinical trials. more than
it’s all about you 140 members of the public joined us in sydney this year to hear
from leading cancer experts including:
ANZUP Consumer Advisory Panel (CAP) Education • Professor Ian Davis, ANZUP Chair and medical oncologist,
Session, 2015 ASM provided an overview of anzup and the importance of clinical
trial research;
L-R Belinda Jago (CAP Chair), Leonie Yong, Colin O’Brien,
David Swallow, John Stubbs, Max Shub, Peter Stanford, • Associate Professor Shomik Sengupta, ANZUP Board member
Ray Allen (CAP Deputy Chair), Jason Grey, Joe Esposito, and urologist, gave an overview of our current clinical trial
Associate Professor Guy Toner, Les Land, Risto Doneski, research portfolio across the four cancers we focus on;
Tony Sonneveld, Margaret McJannett (ANZUP CEO)
• Professor Suzanne Chambers, ANZUP’s Quality of Life and
supportive care committee chair, rn and health
psychologist, gave an especially engaging presentation on
on behalf of the anzup consumer advisory panel (cap),
the impact of life after a cancer diagnosis. she spoke about
thank you for your support throughout 2015 through events
quality of life issues such as sexual functioning and ways of
such as your participation at the community engagement
coping post diagnosis and treatment;
Forum, fundraising activities such as the below the belt
pedalthon, city2surf and city2sea. thanks also to those
• Annabel Childs, a Clinical Trials Nurse Consultant, provided
who have helped raise ANZUP’s profile in the community
some insight into the role of the clincal trial nurse, how they
through the twitter handle @anzuptrials as well as your
provide information, support and help the patient and their
other, varied personal networks.
family navigate through the clinical trial process .
as you will see from ray allen’s story on page 8, the cap’s
• Denis Cubis, gave a moving and very personal account
role is to provide a consumer voice to anzup members as
from a patient perspective. Denis is currently participating
they build new trial concepts. Your voice, fostered through
in anzup’s enzamet clinical trial and gave the audience
the cap members lived experience of their own “below the
a heartfelt assessment of his life on a trial. His closing
belt” cancer journey, ensures that once an anzup trial has
undergone scientific rigor, it also goes through the “what statement was: “You have to give yourself every chance,
about me?” question process. and a clinical trial is the best chance”. every member of the
audience appreciated his approach and honesty.
thanks to grants and the funds raised through the
pedalthon, anzup has had the opportunity to bring • Dr Deme Karikios, a part time medical oncologist and
members together to discuss and explore more concepts currently undertaking his phD spoke about the cost of cancer
this year than in any other. it is a privilege to have been care and cancer drugs is on the rise. Deme examined the
involved both personally and as a cap member in these “side effects” for patients and doctors as costs increase.
exciting new developments.
• Dr Haryana Dillon, Deputy Chair of ANZUP’s Quality of Life
a highlight of our year was the unprecedented success and supportive care committee and psychologist presented
of the anzup asm community engagement Forum. the audience with an excellent guide to sourcing credible health
this free event open to the public, is a feature at the information online. You can read more about this in this edition.
6 a little beloW tHe belt
ANZUP volunteers Lesley Tinkler and Jo Stubbs
• Finally Sophie Scott, renowned ABC medical reporter, We couldn’t do it without you…
treated the audience to how journalists filter information
about current “breakthroughs” in medical science.
she explained her processes and the checks and
balances journalists must put in place to ensure a story For the past four years, two amazing women
does not cause inappropriate hope or heighten anxiety. have volunteered their time and extraordinary
administrative skills to help staff at the anzup
We were fortunate to have two of our most recognised and
well regarded cap members leonie Young and John stubbs Sydney office and the wider ANZUP membership.
fascinated the closing Q&A session. They did a superb job
facilitating what was a most engaging and robust discussion Jo stubbs and lesley tinkler are treasures we wish we
that saw good audience participation and engagement from
could replicate many times over.. their commitment
multiple perspectives.
to ANZUP is exceptional, and their selflessness
the community engagement Forum for 2016 will be humbling.
held in brisbane on sunday, 10 July. i encourage you to
consider joining us – or at least share this invitation with your When you receive a printed copy of this magazine,
Queensland friends. To find our more information go to our
it is because Jo and lesley have printed, folded and
website www.anzup.org.au.
stuffed envelopes for us.
When my daughter bec died from kidney cancer in 2012,
i was determined not to waste the opportunities that We wish to thank Jo and lesley for the hours of work,
unwanted experience that my family and me experienced.
good humour and assistance they have provided to
each member of the anzup cap brings with them their
lived experience – and a dogged determination to help anzup over this time. We are truly grateful - and still
anzup achieve its mission to improve the treatment and can’t believe they turn up week after week and never
outcomes for those affected by urogenital and prostate
receive a cent!
cancer. each day we commit, each story we tell, every trial
we review, we do it for the greater good of cancer patients
both here and around the world. i am grateful for the
dedication and support of my fellow cap members and in
awe of the anzup members who volunteer their time on top
of their day jobs to achieve anzup’s mission.
the one way we can continue to help other patients,
carers, family members and friends is to create awareness.
by reading my story, and the stories of everyone in this
magazine, you are helping to spread the incredibly important
work being done by anzup and co-operative trials groups.
i hope you pass this magazine around. i hope you never
need to have more than knowledge, but if you do need
more you know where to come for the most up to date
information on world-class clinical trials research.
a little beloW tHe belt 7
my experience.
ray allen, anzup cap Deputy chair
ANZUP CAP Deputy Chair, Ray Allen (centre), Dickon Hayne (Chair of Bladder Cancer
Subcommittee) and David Pook presenting at the ANZUP ASM, July 2015
insiDe tHe cap
the anzup consumer advisory the cap reports to the anzup right to make a personal, informed
panel (cap) provides a mechanism board via the cap chair. the cap choice. as consumer advisers, we are
for offering advice from a consumer Chair is a member of the Scientific not asked to provide, or expected
perspective on specific studies, advisor committee (sac) by their to have, specific expertise about the
general research directions and appointment. cap members are scientific or medical merits of a trial.
priorities. invited to participate and provide cap members are asked to provide
input to the anzup sac sub- the perspective of someone who
its key activities cover the committees. the cap is currently has been through a similar or related
consumer-orientated review of specific chaired by belinda Jago, (renal cell experience. their role is to advise
clinical trial concepts, including trial participant’s parent) and ray anzup on the issues likely to affect
validity of overall trial questions, allen, (prostate cancer survivor), is the potential participants in a trial.
comments and suggestions regarding deputy chair.
the protocol, lay summary, patient all anzup cap members undergo
information and consent Form (picF), anzup’s mission is to conduct clinical appropriate training specific
and other issues as requested. trial research to improve the treatment to their role within the panel
of bladder, kidney, testicular and on how to identify research priorities
members of the cap may also prostate cancers. and better understand and contribute
become involved in other activities to our clinical
such as advising on ways to increase Working with our clincal collegues trials research.
the public profile and awareness of we are committed to supporting and
urogenital cancers and the importance promoting each person’s right to
of associated clinical trials. information concerning trials, and their
8 a little beloW tHe belt
ANZUP CAP Deputy
Chair Ray Allen
was asked to provide
an overview of his
involvement as a CAP
member in the Patient
Information Consent
Form (PICF). Ray details
his experience in
reviewing PICF’s from a
patient’s perspective.
roles and responsibilities of the anzup cap
The primary focus of the CAP is to provide ANZUP with a consumer perspective on clinical trials issues including:
• The relevance and focus of new trial concepts and protocols • Advocating for urogenital cancer clinical trials and the
under consideration by the sac and sub-committees; anzup research program;
• Ensuring the PICF is easily understood by participants; • Attending CAP meetings during the year and attending the
ANZUP Annual Scientific Meeting (ASM);
• Identifying gaps in research;
• Contributing to the ANZUP ASM and Community
• Advising on patient recruitment strategies; engagement Forum;
• Leveraging their networks to promote ANZUP and our • Working with ANZUP to improve community understanding.
trial activities;
if you are interested in being involved with the anzup cap,
please contact ANZUP Chief Executive Officer, Margaret McJannett: [e-mail]
a little beloW tHe belt 9
consumer testing the picF
the medical and health sectors love their acronyms and my experience reviewing a patient
abbreviations, and no wonder when you see some of the
scientific terms and drug names. Many are longer and harder information consent Form
to pronounce than the names of certain Welsh towns.
Like a detailed set of plans, specifications and engineering as a member of the cap, i have been personally
drawings for a bridge or a city building, the working manual involved in the review of a broad range of trials across
for a clinical trial, known as the protocol, is a complex the different disease groups. beginning with the picF,
document, prepared by a multi-disciplinary team of health i place myself in the position of a potential trial
professionals which sets out every aspect of the conduct of participant and make a note of the questions that
a trial. it will contain detail on the rationale and objectives, arise as i read the document. i will try to look at the
participant suitability, precise details of dosage, attendance picF both from the perspective of a participant with
requirements, risks, and outcomes. the protocol is written in little or no knowledge and experience of their disease
technical language aimed squarely at the highly skilled clinician or the trial process, and a participant who might have
who will implement the trial, often in multi-centre locations, and many years of wearying involvement. i look to see if my
is not generally in a format useful to most trial participants (the questions are adequately answered in the picF. i check
patients). For example, i recently reviewed a trial protocol and to see if the treatment schedule is correctly calculated
counted 45 abbreviations used throughout the document! and conveyed in the document. i look for wording that
may be counter to the participant’s self-esteem; nobody
an integral component of a clinical trial protocol is the wants to be thought of as a lab-rat.
requirement for informed consent. in a nutshell, this is a
requirement that the trial participant is given sufficient relevant Where a question is not adequately answered,
information about the objectives, methodology, risks and at least to my satisfaction, i look to the protocol.
potential outcomes so that they can make an informed decision the answers are usually there but, often for good
on whether or not to proceed. the picF is a form designed to reasons, have not been included in the picF. i’m not
provide comprehensive information to the potential participant there to review the Protocol. For a start, I’m not qualified
and to provide written confirmation that informed consent has to do so. and, more importantly, there are many levels
been obtained. it must be obtained for every trial participant. of review within anzup that will deal with the concept,
aims, and procedures. the fact that the protocol has got
anzup’s cap plays the important role of reviewing the this far means that it has gone through a very
picF as a trial proposal moves towards implementation. robust process of review.
the cap review is an integral step in the approval process.
in the end, each member of the acap review team
a team of three to four experienced cap members will needs to be able to say that they understood the
be assigned to a typical picF review. each will conduct an information contained within the picF and would be
independent review, with findings and suggestions brought happy to enter the trial based on that. the review
together via teleconference. members possess a wide process ends with the review team making a set
range of individual skills and experience. the review of recommendations encompassing suggested
team will seek a clear and definitive answer to the changes and additions for return to the protocol
question of whether sufficient information is being author(s). i am happy to say that, in my
provided in a clear and understandable form to experience, suggestions emanating from the
assist the prospective participant to make a cap are seen as a constructive and valuable
decision about entering the trial - and that contribution to the final form of the trial.
the patient understands the risks and
potential benefits.
1100 aa lliittttllee bbeellooWW ttHHee bbeelltt