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A Personal Experience with
Clinical Trials
Introduction
Ian Liston has provided an informative perspective on
joining clinical trials. He lives in the United Kingdom. The trials he has been on are many:
In addition to the above four, he's taken part in a
couple of other trials that did not involve medications.
he also provides blood
samples to try to determine the effect of hormone therapy on established
bone metastases (on-going with bone scans) and another one evaluating the
usefulness of circulating tumor cells (CTCs) which has been going on for
over 2 years.
Essentially, he is doing sequential clinical trials as
opposed to sequential second line hormone therapy or sequential
chemotherapy. This provides another option for some men fighting HRPC.
Ian Liston - a Patient's Perspective on Clinical
Trials.
This is an edited version of
the speech I gave to The Royal Society of Medicine conference on Prostate
Cancer in London on 16th July 2007. –
I addressed the topic of Prostate Cancer from the patient’s perspective with
an emphasis on taking part in medical trials.
In January 2003, I had been showing a few
distressingly common problems with the waterworks and my GP (General
Practitioner = MD in the USA), at my annual check-up, found my prostate to
be hard and enlarged. A blood sample showed my PSA was 78.00.
By co-incidence a few days previously I’d read an
article in The Times newspaper by Dr Tom Stuttaford on Prostate Cancer and
it reminded me in no uncertain terms that my father had died in 1985, slowly
and painfully - of Prostate cancer.
In February 2003, after referral for biopsy and
further blood tests, my urologist confirmed I had Prostate Cancer. The
biopsy indicated a Gleason Grade 7. The ‘staging’ was T3b, N1 M1.–
it was too late for a radical prostatectomy, brachytherapy, cryosurgery or
even then the very new technique of three dimensional conformal
radiotherapy. HIFU had barely been heard of.
A course of hormone therapy: Casodex (150 mg/day) lasted 12 months and Zoladex (3.6 mg implant monthly and still
continuing) was the only viable option and I took it willingly in the hope
that it would give me some precious time.
This is an indeterminate but finite therapy and
after nearly two years I began to show signs of being hormone refractory /
castrate refractory / androgen independent
–
call it what you will.
My oncologist referred me to the Royal Marsden
Hospital in Sutton, Surrey, UK to see if I might be suitable for a
clinical trial …. and my luck was in. I was offered a Phase 1 trial for a
new drug called CP671,871, an Insulin-like growth factor receptor inhibitor
which theoretically interfered with the growth of prostate cancer cells, and
which was to be given in conjunction with Taxotere, a new chemotherapy drug
not then available in the UK but rapidly assuming ‘gold-standard’ status in
the USA.
I was assured that I could withdraw from the trial
at any time and this would not affect my standing with the hospital. I would
continue to be treated come what may, even if I decided
– without giving any reason –
to withdraw from the trial. I could also continue after the trial with the
drug, if risk and side effects did not outweigh overall benefit. These are
common attributes with most medical trials in the UK. A stringent trial
protocol, approved by the Medical Research Council Ethics Committee and the
Medicines and Healthcare Regulatory Authority, was in place and my later
experience showed that the protocol was followed to the letter.
I began the trial in May 2005. Within a few months
my PSA had dropped from 17.8 to 6.8. The side effects were unpleasant but
bearable and I completed nine cycles of taxotere and 13 of CP671,871. They had a demonstrable and beneficial effect and stabilised my
prostate cancer.
By late
March 2006, close monitoring on a monthly basis showed that my PSA was
beginning to rise again and I was offered another trial -
Halichondrin B
(E7389)
– a
substance derived from sea sponges that had shown great promise in the
laboratory.
After 4 months, Halichondrin B didn’t seem to be
giving me much benefit. The side effects weren’t as severe as with Taxotere
but it wasn’t a particularly pleasant experience, even more so as my PSA was
still rising and there was some evidence of increased activity in my bones.
So, as part of a multi-disciplinary approach where different medical
specialities combine together to seek new treatments, we went to the next
trial: Alpharadin - an isotope of Radium 223 injected once a month.
At the end of that three month trial, CT and MRI
scans showed there was a significant change for the better in bone and
tumour markers, although it didn’t have any effect on my PSA, which was 11.3
at the start and 13.8 at the end of that particular trial.
Again, I was monitored on a regular basis so the
fact that my PSA was on a fairly rapid rise again was a warning signal.
Luckily at that time, Nov 2006, approval was given for a protocol for
patients such as myself with previous experience of chemotherapy (Taxotere)
to take part in the trial of a drug which is now causing a great deal of
interest worldwide.
Abiraterone Acetate. Developed in the UK at the
Institute of Cancer Research, it had shown considerable promise in early
trials with significant and sustained PSA reduction in a large majority of
patients. Prior to the start of the trial on Dec 15 2006 my PSA was 33.3.
Just 14 days later it had dropped 14 points to 19.3. On July 3rd 2007 - it
had shown a seventh decrease in as many consecutive months … to 1.3.
Of the five trials in which I’ve so far
participated, it’s the only one without any significant side effects apart
from slight fatigue. Four pills each morning before breakfast and that’s it.
Results in the UK are being reflected by those at Memorial Sloan Kettering
in the USA and I understand that from early 2008 the trial will be extended
on a world-wide basis.
When I started the first trial with taxotere and
CP671,871 I was convinced that I was on the first step of a journey that
would take me from being caught with a terminal disease to being someone
with a chronic illness.
That feeling is even stronger today than it ever
was. Trials have paid off for me by buying time during which it is becoming
increasingly clear that there are hugely significant advances in the
pipeline which are being converted rapidly into practical reality.
One must also remember that all men are different,
their cancers are different and they react in different ways. Our own unique
cancer cells didn’t go to medical school: they don’t read the medical
literature … or participate in internet groups!
Of course there can be no guarantees but, such is
the state of current research, it’s a fair bet that a trial will hopefully
give a significantly increased survival benefit, whatever the stage of one’s
prostate cancer.
To those uncertain about participating in trials I
can only say that it was the best decision I ever made. I fceel healthier
than I have for years and, at this moment in time, my condition has stabilised. I perish the thought of what might have been if I had not
embarked on this adventure.
I wouldn’t deny for one minute that I’ve been lucky
enough to live close to a world leading cancer hospital. Thankfully I also
have in free and unlimited doses, the greatest medicines I’ve ever heard of:
PMA –
positive mental attitude and, in my case, tloagw the love of a good woman.
I believe we are close to turning the corner with
Prostate Cancer from terminal to chronic. Where, instead of treating
palliatively towards an inevitable end of life scenario, we are being
treated for long term benefit. I for one intend to celebrate the occasion
when the corner is turned and am more than happy to play a part, no matter
how small, in achieving that goal.
© Ian Liston - July 2007
No reproduction please without authorisation
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