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Medical Forum / Diseases and Disorders / Prostate Cancer / July 2008

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abiraterone - radio clip (Mike - will you get on this trial?)

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rosbif - 22 Jul 2008 08:44 GMT
Short radio clip from R4's 'today' prog...Nick Robinson ('prostrate'
cancer) is better at politics than medicine..

http://news.bbc.co.uk/today/hi/today/newsid_7518000/7518780.stm

Sounds good! - targeting aggressive PCa, trials underway, 3 years from
general availability.

Can you get this too, kh?
kh - 22 Jul 2008 11:29 GMT
> Short radio clip from R4's 'today' prog...Nick Robinson ('prostrate'
> cancer) is better at politics than medicine..
[quoted text clipped - 5 lines]
>
> Can you get this too, kh?

This sounds VERY good.

I figure that the Taxotere and CNTO (328) trial will give me at least
that much time.   I'm not stopping the trial as it is working well for
me.

I'm beginning to understand that this really is a maintenance, keep at
it, deal.

I'm guessing that abiraterone will move to the head of the list of
secondary treatments, maybe to the absolute front of the list if it
works long enough.    Could that be?  Newly diagnosed could go on
abiraterone and surgery and radiation would be held in reserve?

One striking thing in the articles is that they applied it to
advanced, aggressive cases and it gave good results.   I didn't see
anything about failures.  The articles did mention that abiraterone
didn't work for everyone.

Yeah, this is great news for all of us.

-kh
rosbif - 22 Jul 2008 16:12 GMT
>> Short radio clip from R4's 'today' prog...Nick Robinson ('prostrate'
>> cancer) is better at politics than medicine..
[quoted text clipped - 11 lines]
>that much time.   I'm not stopping the trial as it is working well for
>me.

Quite, ships mid-stream etc..

>I'm beginning to understand that this really is a maintenance, keep at
>it, deal.
[quoted text clipped - 3 lines]
>works long enough.    Could that be?  Newly diagnosed could go on
>abiraterone and surgery and radiation would be held in reserve?

That does look like a possibility.

>One striking thing in the articles is that they applied it to
>advanced, aggressive cases and it gave good results.   I didn't see
>anything about failures.  The articles did mention that abiraterone
>didn't work for everyone.
>
>Yeah, this is great news for all of us.

Think I'll celebrate by giving the £1 Normandy plonk a miss tonight
and open a half-decent shiraz to go with my honey-roasted duck-breast.

http://www.videojug.com/film/how-to-make-honey-roasted-duck-breast-salad

(recipe starts 20 secs in after ads)

I'll drink to your health.

>-kh
tarhoosier@carolina.rr.com - 22 Jul 2008 15:35 GMT
> Short radio clip from R4's 'today' prog...Nick Robinson ('prostrate'
> cancer) is better at politics than medicine..
[quoted text clipped - 5 lines]
>
> Can you get this too, kh?

Mike pointed us to this audio report a few months ago. Thank you,
Mike.

http://www.prostatecancerupdate.net/download-audio/pcu/2008/1/default.asp
or
http://tinyurl.com/2tngfa

Where Peter Scardino discusses Abiraterone and also MDV 3100, from
Medarex and Howard Scher. Note: in the listing of the Scardino
interview Track 5 is actually about MDV 3100 and Track 7 is AA, as
listed. Scardino believes that these two together, with chemo could
provide long lasting remission for men with metastatic prostate
cancer. I have a dream.

tarhoosier
rosbif - 22 Jul 2008 16:15 GMT
>Mike pointed us to this audio report a few months ago. Thank you,
>Mike.
[quoted text clipped - 11 lines]
>
>tarhoosier

Sorry, hadn't realised this was old news.  The radio clip was this
morning a.m.

But I got the impression it was hoped that this would be a relatively
low toxicity replacement for chemo, rather than an addition to it.
Then again, I suppose there are those who will want to hit it with
everything.
MikeHi@anon.com - 22 Jul 2008 17:26 GMT
It's front page headline news in The Times today.

http://www.timesonline.co.uk/tol/life_and_style/men/article4375429.ece
or
http://tiny.cc/Oms01
EXCERPTS :
Advanced prostate cancer is typically treated with a form of chemical
or surgical castration to block production of the male hormones.
Abiraterone blocks the generation of these hormones in the testes *and
elsewhere in the body* (Mike's emphasis + Wow! Five little words),
including the generation of hormones in the cancer itself.
The pill decreased the size of tumours in 70 to 80 per cent of men
with advanced prostate cancer, the researchers said. Patients also
recorded large falls in prostate specific antigen levels in the blood
- a key indicator of prostate cancer.
"Current treatments can be horrible, and carry side-effects such as
loss of libido, but in some cases the cancer seems immune to therapy
and carries on accelerating," Dr de Bono said. "We believe that the
cancer cells can make their own hormone 'fuel' to grow and survive. We
believe we now have a drug that can block the ability of the cancer to
make that fuel."

Hi Tarhoosier. You refer to my original post:

http://www.prostatecancerupdate.net/download-audio/pcu/2008/1/default.asp
or
http://tinyurl.com/2tngfa

and you end …
>Scardino believes that these two together, with chemo could
>provide long lasting remission for men with metastatic prostate
>cancer. I have a dream.

Dr De Bono of the aberiterone study gives a (usually avoided) time.
According to The Times he… "said he hoped that the new drug could be
licensed and available for treatment of advanced disease within three
years. He suggested that it could eventually make chemotherapy
obsolete.'

Scarrdino was saying that hormone therapy is weak and will soon go out
of the window (my words, of course). Now de Bono's saying that about
chemo too!   So Tarhoosier: the other guy who had a dream saw it come
alive!  Yours ain't far-fetched any more. Keep smiling!

Hi Rosbif.
You asked if I could get on the trial - my new onco knows I want to be
on one.
The Times writes: 'An international study aims to recruit 1,200 men
with advanced prostate cancer.'

Rosbif - you can take that as 1,199 men. I see my new onco in only a
week. I'm a target candidate. I'll report back. I'll either be on it
or my onco will be walking with a permanent limp. (No, no, no - if the
political correct police are reading this too - I'm only joking…ha,
ha, ..well…...sort of….).

And alright, alright, I know all the ifs and buts. But I've been
signing off for ages as:

MikeHi
"Exponential lightspeed". Def: The discovery of the cure for Pca at a
speed which defies Einstein.

If it's not abiraterone it surely will be something similar, soon. The
writing is on the wall, has been all this year, right in our faces.

The little bit of a bugger tweaking in the back of my own little head
in all this is that, at this hopeful moment, I may be diagnosed, as
I've posted in recent days, with some non-treatable neurological
consequence of tumors. Neatly summed up in a response by Ronju:

>From my understanding from what my wife tells me if you did have
>myasthenia gravis, prostate cancer would be the least of your worries.

[Ronju, will send you my bills for the extra whisky botles..:-)  ]
I'm seeing that specialist three weeks after my onc. I think I'll keep
that quiet next week. I don't want the onc to say, "Well if you're
going to cough it anyway, no point wasting you on a trial!"

And kh, after all you've been through, we don't want you to go of
sunstroke just when the cavalry's appearing. Here's the best and
simplest and surest therapy you've ever been offered. You've got a
bald head. Wear a sun hat. Works wonders.

My best wishes to everybody - and they are hopeful best wishes.

Meanwhile  I remain, yours truly

Mike Hi
"Exponential lightspeed". Def: The discovery of the cure for Pca at a
speed which defies Einstein.   …
rosbif - 22 Jul 2008 18:23 GMT
>I'm a target candidate. I'll report back. I'll either be on it
>or my onco will be walking with a permanent limp.

Kindly provide address of railings if you need me to chain myself up
in support of your demands for this.  If there's any self-hurling
under the Queen's horses......I might have to leave that to you....
tarhoosier@carolina.rr.com - 22 Jul 2008 22:25 GMT
> >I'm a target candidate. I'll report back. I'll either be on it
> >or my onco will be walking with a permanent limp.
>
> Kindly provide address of railings if you need me to chain myself up
> in support of your demands for this.  If there's any self-hurling
> under the Queen's horses......I might have to leave that to you....

Not really old news. The appearance and testing of AA and its promise
has been known for some time. The advancing to Phase III, the use of
chemo refractory patients as the first trial group, and the release of
the full Phase II results with patient anecdotes, and predictions(!)
from such an august voice as Dr de Bono is newly news.
J - 23 Jul 2008 08:11 GMT
> > >I'm a target candidate. I'll report back. I'll either be on it
> > >or my onco will be walking with a permanent limp.
[quoted text clipped - 7 lines]
> chemo refractory patients as the first trial group, and the release of
> the full Phase II results with patient anecdotes, and predictions(!)

The Phase III trial is in 37 locations
http://clinicaltrials.gov/ct2/show/NCT00638690
and it's not proven helpful for bone mets, so may help a small subset who
have other mets, but not brain mets.

"  A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of
Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic
Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based
Chemotherapy
Estimated Enrollment:     1158
Study Start Date:    April 2008
Estimated Study Completion Date:    June 2011
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator,
Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy
Study
Primary Outcome Measures:
   * Overall Survival [ Time Frame: During the Study ] [ Designated as
safety issue: No ]
Estimated Primary Completion Date:     June 2011 (Final data collection
date for primary outcome measure)
37 Study Locations

So it looks like it could be palliative, after Docetaxel, and before bone
or brain mets show up.
J
kh - 23 Jul 2008 01:12 GMT
On Jul 22, 12:26 pm, Mik...@anon.com wrote:

> And kh, after all you've been through, we don't want you to go of
> sunstroke just when the cavalry's appearing. Here's the best and
> simplest and surest therapy you've ever been offered. You've got a
> bald head. Wear a sun hat. Works wonders.

I must be a mad-dog to go out into the sun, only one type does that.

I was out there on purpose, trying to get the sides tanned to match
the top.  When my hair fell out, I discovered pale sides and a tan
top.  These are called the "White-sidewalls" look.   I was developing
the "Friar Tuck" look with heavy hair on the side and bald on the
tippy-top.

This abiraterone is great news but I'm not getting my hopes up....
Who am I kidding.  This is the news I've been waiting and watching
for.  My hopes are up. Wa-hooo!  You all read the articles and patient
experiences!

A couple pills once a day.

-kh compared to the half dozen I take now.
MikeHi@anon.com - 23 Jul 2008 12:58 GMT
What is maybe interesting is the speed of development. I first
highlighted abiraterone (we better get used to calling it AA) from
this Institute of Center Research site March 10.

http://www.icr.ac.uk/research/new_research_highlights/research_highlights/8727.shtml
or
http://tiny.cc/WRD7M
Dr de Bono then concluded the report: "Further evaluation of
abiraterone, with American collaborators, is now ongoing with a view
to pursuing, in the near future, the studies required for regulatory
approval of the drug so that it can ultimately be used routinely in
hospitals", concludes Dr de Bono.

So in four months it's gone from 'what might be' to what is now
happening. I've already mentioned that in the latest report Dr de Bono
forsees three years for likely hospital ready.

Here's a guess for kh and others. Available in two years.  If in
another year the studies continue to confirm the findings - these
trials too will be raced forward. Because if it does what it says on
the box, the clamour to get it out and save lives will be quite
something -and in the case of extreme sufferers, what's to lose?
If the kh's of this world say, 'Hey! I'll take it -and S/E's are down
to me' - who would stop them?

(Note for ng purists. A'guess' ranks even lower than 'anecdotal' by
way of evidence.)

>J writes: So it looks like it could be palliative, after Docetaxel,
> and before bone or brain mets show up.

J, it's right the clinical research said Docetaxel had to have been
used and failed on trialists.  That's the fatal, uncurable, type the
research has focussed on.
But I do not think that is  *only* when it is going to work - if this
phrase from the ICR research means anything:

    'Abiraterone blocks the generation of these hormones in the
testes and elsewhere in the body, including the generation of hormones
in the cancer itself. '

So it should surely block the cancer when it is present, at whatever
stage. Even if the Pca becomes high risk metastatic before the use of
any HT or chemos (like me). But for those who have become hormone
resistant (and we know that then *new* pathways for the cancer are
opened up) it is the BIG white hope.  

>Rosbif wrote:
>I got the impression it was hoped that this would be a relatively
>low toxicity replacement for chemo, rather than an addition to it.
That's certainly how I read the ICR report. The AA pill. Few side
effects.

(Chain yourself to the railings? Nahh. You gotta be a woman and do
that and get noticed. ..I'd only have to come and feed you..)

My very best wishes and big hopes for all.

MikeHi
"Exponential lightspeed". Def: The discovery of the cure for Pca at a
speed which defies Einstein.
kh - 23 Jul 2008 13:42 GMT
On Jul 23, 7:58 am, Mik...@anon.com wrote:

> J, it's right the clinical research said Docetaxel had to have been
> used and failed on trialists.  That's the fatal, uncurable, type the
> research has focussed on.

Even at Stage 3, abiraterone is "experimental".  Of course, the trial
is limited to "labrats" (like me), everything else has failed them,
they have nothing to lose.   I'm sure they're all hoping that it works
for them but these are guys who are in pain, with mets, having failed
Lupron, Taxotere, and are looking at a bleak future.

Taxotere plus CNTO(328) is working well for me, so I'm not a candidate
for abiraterone, not yet.

> So it should surely block the cancer when it is present, at whatever
> stage.

I'm guessing that this one gets fast-tracked, they stop the trials,
and open it up before 2 years.    They won't have the long-term stats
in but who cares.

I agree with Mike, they're doing advanced cases because the advanced
have nothing to lose.  Give us some hope and we'll sign up for the
"human trials".

If abiraterone works anything like the reports, it will replace Lupron
in 2 or 3 years and probably make Watchful Waiting, with intermittent
abiraterone, the treatment of choice in 5 years.    This is way
optimistic but why go for radiation or surgery?

Imagine a future where this disease is controlled by a couple
pills.     It could happen.

-kh
tarhoosier@carolina.rr.com - 23 Jul 2008 14:31 GMT
> On Jul 23, 7:58 am, Mik...@anon.com wrote:
>
[quoted text clipped - 31 lines]
>
> -kh

According to Dr. Lam in the U. S., director of one of the sites for
the Phase III trial, there are plans for another Phase III open before
the end of this year for men who are docetaxel naive. I believe that
targeting tax failures first puts the medicine into those most in need
and also means that the opposing placebo arm of the trial is unlikely
to compete against AA. There is currently no approved therapy for tax
failed PCa patients, thus the bar is "low" for AA in this setting. And
results for tax failures will be in a short time line, unlike for
others who have an overall survival measured in years
J - 23 Jul 2008 23:05 GMT
> On Jul 23, 7:58 am, Mik...@anon.com wrote:
>
[quoted text clipped - 15 lines]
> in 2 or 3 years and probably make Watchful Waiting, with intermittent
> abiraterone, the treatment of choice in 5 years.

Or if it's not better than what's currently available, they'll have used
up the medicine they've produced for the clinical trials and that'll be
the end of it.
J
Steve Jordan - 23 Jul 2008 21:23 GMT
(snip popular press article)

This was a Phase One trial, the purpose of which is to determine safe
dosage levels, among other things.

It appears nevertheless to be cause for hope, but we've all seen that
before.

Fingers crossed but not hyperventilating. Yet. There is a long way to go.

Here's the hard science:

Attard G, et al., "Phase I Clinical Trial of a Selective Inhibitor of
CYP17, Abiraterone Acetate, Confirms That Castration-Resistant
Prostate Cancer Commonly Remains Hormone Driven." J Clin Oncol. 2008
Jul 21.

Conclusion, in pertinent part: "CYP17 blockade by abiraterone acetate
is safe and has significant antitumor activity in CRPC*.

*Castration Resistant Prostate Cancer

See www.pubmed.gov which is a service of the US National Library of
Medicine.

Search on PMID: 18645193

Regards,

Steve J
 
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