Hi all,
I am a candidate for the UK trial as I meet all the critera and should
be starting in the next few weeks. In the UK it is "Phase 3,
Randomized, Double-blind, Placebo-Controlled Study of Abiraterone
Aceate (SB7630) Plus Prednisone in Patients With Metastatic Castration-
Resitant Prostate Cancer Who Have Failed Docetaxel-Based
Chemotherapy".
Sure I accept that I will be a "lab rat" but this trial at least
offers me a glimmer of hope as everything else (RT,Chemo,DES) has
failed. [I just hope that I am not one of the 33% who get the
placebo!]
I am looking for anyone who has been on any of the Phase 1 or 2 trails
to get their experiences. Please contact me via the group, email or
via bollocks-to-pca.org on which I am the webmaster.
Cheers
Bernie
rosbif - 26 Jul 2008 10:08 GMT
>Hi all,
>
[quoted text clipped - 16 lines]
>Cheers
>Bernie
Best of luck Bernie! Damn that placebo.
I hope you'll pop back and let us know how it's going.
kh - 26 Jul 2008 13:21 GMT
> Sure I accept that I will be a "lab rat" but this trial at least
> offers me a glimmer of hope as everything else (RT,Chemo,DES) has
> failed. [I just hope that I am not one of the 33% who get the
> placebo!]
Bernieboy, my fellow Lab Rat,
Please post your experiences here. How is your health? PSA, pain,
mets, etc?
I'm keeping my fingers crossed for you, that you get the Abiraterone,
that it works great for you, and that the side effects are nominal.
Let us know everything about the trial.
Thanks for leading the way,
-kh
Bob C. - 26 Jul 2008 14:04 GMT
> Hi all,
>
[quoted text clipped - 16 lines]
> Cheers
> Bernie
Bernieboy, I sure do hope that you post your experiences here, there are
a lot of us that will be watching your progress and praying for you. KH
seems to be our current Pathfinder, as another poster has referred to
him, and I am sure that kh especially will be happy to share that role.
Even though you might get the placebo at first, you should still be
placed on fast track to get the real thing should the trials prove the
drugs to be effective. The very best of luck to you, and you will be in
our prayers.
MikeHi@anon.com - 27 Jul 2008 10:07 GMT
>I am a candidate for the UK trial as I meet all the critera and should
>be starting in the next few weeks. In the UK it is "Phase 3,
[quoted text clipped - 7 lines]
>failed. [I just hope that I am not one of the 33% who get the
>placebo!]
Hi Bernie
Very best of luck with getting on the trial. It certainly appears to
be a great hope.
As someone with lots of negative Pca prognostics, but who has not
'Failed Docetaxel-Based Chemotherapy', I don't qualify. But it's
surely right that your category, guys who've been through everything
with no positive result, should get priority. It should then become
available to all with poor pognostics.
Sorry to sound one note of caution. The study is apparently seeking
2,000 trialists internationally. That doesn't sound like very many, to
put it mildly.
There's plenty to cheer about anyway. White cell immunotherapy looks
outstanding and the researchers' aim is that we should know about it
in a positive way by the turn of the year.
The very best of luck to you for getting in the trial..
My best wishes and lots of hope to everybody.
MikeHi
"Exponential lightspeed". Def: The discovery of the cure for Pca at a
speed which defies Einstein.
(Q. for Alan - why so few AA trialists? What's the science? Like a
poll of 2,000 to accurately represent a nation's opinion?)
Alan Meyer - 27 Jul 2008 20:51 GMT
> ...
> (Q. for Alan - why so few AA trialists? What's the science?
> Like a poll of 2,000 to accurately represent a nation's
> opinion?)
Our mathematicians (len, chasjac, others?) could give you a
better answer, but I think a sample size of 2,000 in a well
designed trial is actually quite large.
It's been years since I studied this stuff and I don't remember
enough, but there is a formula that can be used to relate sample
size and confidence in the conclusions drawn from the sample. I
remember one rule of thumb in use many years ago was that samples
above 250 were considered very good.
The required sample size is also related to the study design. If
you have tight control of all variables, you can use a smaller
sample. If you don't have tight control, you need a larger
sample in order to drown out more of the possibly non-random
variations.
As you can imagine, running a trial is very expensive. Sometimes
the drug itself is very expensive - especially given that the
inventor of the drug does not yet have a production line in place
to produce it and is working with small batches made by hand.
But even apart from the drug cost, and often much more than that,
there is the cost of recruiting the patients, counseling them,
administering the treatment, performing tests before and after
treatment, paying for time on expensive scanners or other
equipment, following up, correlating results, writing them up,
getting them reviewed, and so on. So there is a great incentive
to keep sample sizes as low as possible and still get results in
which we have high confidence.
It can also be difficult and time consuming to recruit patients.
You need a lot of publicity to stir up interest. You need to
recruit a lot of geographically disbursed study sites - and get
the interest and participation of the doctors in those sites.
Doctors don't always have time to take on new things, and
patients are often skeptical about being "lab rats". Most
patients couldn't give a hoot about research. Most want everyone
else to try the new drugs. For themselves, they want the proven
cure.
The Phase II trial I was in was hoping for a sample of 30 men and
considered that 18 would be enough to get a minimally valid
result. In the event, they were only able to recruit 11 men, in
spite of the fact that the trial was run in a large metropolitan
area (Bethesda, MD, in the environs of Washington DC) and that
all costs were paid for by the researchers.
The abiraterone trial can probably recruit men more easily
because they are looking for men who really have few or no other
options.
Alan
Bernieboy - 28 Jul 2008 16:52 GMT
> Mik...@anon.com wrote:
The abiraterone trial can probably recruit men more easily
because they are looking for men who really have few or no other
options.
Too true Alan - that's why I am on it :-)
Cheers
"Lab rat" Bernie
PS
RT, Chemo and diethylstilbestrol although reducing PSA had no lasting
effects so not a lot left in the tool box.
Steve Kramer - 27 Jul 2008 18:30 GMT
> Hi all,
>
[quoted text clipped - 4 lines]
> Resitant Prostate Cancer Who Have Failed Docetaxel-Based
> Chemotherapy".
Good luck with that, Bernie. Please keep in touch.
I don't know if you read the earlier email, but several here exclaimed how
much we appreciate "the lab rats" in the U.K. on these trials.

Signature
PSA 16 10/17/2000 @ 46
Biopsy 11/01/2000 G7 (3+4), T2c
RRP 12/15/2000 G7 (3+4), T3cN0M0 Neg margins
PSA <.1 <.1 <.1 .27 .37 .75 PSAD 0.19 years
EBRT 05-07/2002 @ 47
PSA .34 .22 .15 .21 .32 PSAD .056 years
Lupron 07/03 (1 mo) 8/03 and every 4 months there after
PSA .07 .05 .06 .09 .08 .132 .145 PSAD 1.4 years
Casodex added daily 07/06
PSA <0.04, <0.05, <0.04, <0.04, <0.1 2/12/08
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