trial can be a very difficult decision to make, yes I firmly believe it is lot easier
with a later/more aggressive diagnosis
of PC, to make the decision. You have also to make the decision for yourself,
that is the hope the drug is going to give you help. I admit I am probably
being a bit selfish in this regard but
that is the main reason I joined, as an offshoot I hope that I can help guys
following me in their journey with this horrific disease.
I think it also depends on the stage of the trial, Stage 1 and 2 trials could
be a lot riskier but I think generally these are offered to people with very
advanced disease and do not have a good prognosis. When it gets to stage 3
trials I feel these are getting to be not really risky. At this stage they are
trying to actually prove that the new drug outcome is better than an existing
treatment. Also to get a better view of any side effects.
I was Dx
with PC in July 2010 aged 66, my PSA was 254, my biopsy result was Gleason 9 in
50%, Gleason 8 from 40% and 1 negative from 12 cores. CT and Bone scans
confirmed Metastized PC in my bones and lymph nodes. So my PC was well advanced with limited treatment options and definately not curable.
I started Cosudex late July 2010 for 4 weeks and had my first Zoladex injection
mid August 2010. I am still on quarterly injections, my next is in November.
I am very
fortunate I am not in any pain, the only symptom I have is urinary frequency
(and this is not necessarily a symptom of PC). The only indicator I have of PC
is my PSA, Biopsy results and the evidence of my scans.
about 8 months my PSA was down to 3.2 (April 2011) this was as low as it got.
After April my PSA started to rise again and over the next 6 months my PSA
almost doubled. After getting over my cardiac surgery I thought more about my
PC and decided to do some research and find out more about this cancer. I was
shocked to see the information and the information I wasn’t told about. I also
discovered information about clinical trials and decided that I would join a
trial in the future when my cancer started to take off. Little did I know that
this was going to be sooner than later.
I had read
about MDV3100 and was impressed with the results of the Affirm trial and
decided that the Prevail trial sounded like the suitable trial for me, that is
if I was selected.
My reasoning for a clinical trial basically was what were my choices, be
proactive ? or be reactive ? If I chose the latter I would wait until my PC got
worse and then go down the radiation or chemotherapy roads, and perhaps suffer
the side effects of these earlier than later. Or if I was proactive, join the
MDV3100 Prevail trial. The Affirm stage 3 trial of MDV3100 showed a nearly 5
months extension of life after chemotherapy, I reasoned that the guys in this
trial were much further down the track in their PC journey compared to mine, I
should get better results. Naturally you will never know if you made the
follow up scans in November 2011 which confirmed the cancer in my bones had
progressed. My decision was wait and see or go with a trial. After much
agonising and reading I decided to try to postpone the chemo or radiation for
as long as possible and I felt that the Prevail trial gave me the greatest opportunity
of doing this. So I had my physical, blood tests, and medical reports assessed
and I was told I qualified. I think there were less than 10 positions available
at my hospital. I took all of 10 seconds to accept the offer. I started the
trial mid December 2011.
fully aware, but worried that I would get the placebo, however, was prepared to
take the risk. My PSA continued to go up and down over the next 5 months, my
bi-monthly scans indicated no change from the starting scans. In hindsight the
fact that the scans showed no change should have indicated something was
happening, but I think you expected a miracle and there would be an immediate
change. My human brain keep telling me placebo, placebo ! In these trials you can drop out at any time,
however, I felt I had made the commitment and would stick with it, it was my choice
to join and I would stay for the long haul.
I was getting depressed and worried that I had
made the wrong choice and had scored the Placebo. This was a very difficult
period psychologically for me, my PSA number was going up and down but overall trending
up, scans showing no change.
come June 2012 the scans still showed evidence of my PC but the cancer was now
classified as immeasurable. This is a miracle; my August scans showed no change
from June and again was classified as immeasurable. My October 2012 PSA is now
back to about the same as in October 2011. My PSA hasn’t showed the dramatic
drop in level that about 80% of the Affirm Trial participants enjoyed. I
obviously fall into the other 20%. The PSA number is difficult, your life
hinges around this number, if it is up you are down if the number is down you
are up. (a bit like an umbrella in wet weather !)
participants point of view having a placebo in the equation is very difficult
and could be very damaging psychologically, I know from a scientific angle the
need to demonstrate a distinct improvement over the standard treatment and also
that any improvement is actually due to the new drug, not due to other factors.
Overall the testing process is very complicated and costly, but the rewards can
be huge for the drug company if they can develop a better drug for a given
most of the drug companies when the trial finishes offer the “real thing” to
the people who were on the placebo. This would hopefully enable them to gain
some benefit from the new drug.
other hand I am probably getting better care being in the trial because of the
monthly visits to the hospital, monthly blood tests, bimonthly scans etc, and
other monitoring that you are undergo. My commitment is to go each month to the
hospital for these tests and also keep a diary of how you feel and what
medication you take each day. In my case this is all easy and I do not find the
requirements very onorous.
In my case
the side effects in addition to the ones from Zoladex, are some headaches, a
bit more fatigue , some diarrhoea and an increase in blood pressure.
Hope this gives an insight to my experience and thoughts on clinical trials and helps others who may be considering a trial.
Age at diagnosis 66 (July 2010), PSA 200, highest PSA 254, lowest PSA 3.2, Gleason Score 9, 50% 4+5, 40% 4+4, 1 core negative, treatment cosudex and Zoladex , PC metastized to lymph nodes and bones. Joined Prevail trial MDV3100 December 2011, CABG in August 2010 , 2010 was a hellava year !