Alpharadin clinical trial announced in USA
Lud
radiopharmaceutical clinical trial finally comes to USA.
Phase III randomized clinical trial for Alpharadin to be commenced
18. November 2009 01:30
International prostate cancer expert Dr. Oliver Sartor of Tulane Cancer
Center is the first oncologist in the United States to offer patients an
experimental new treatment for late-stage prostate cancer through a
multi-center clinical trial
International prostate cancer expert Dr. Oliver Sartor of Tulane Cancer
Center is the first oncologist in the United States to offer patients an
experimental new treatment for late-stage prostate cancer through a
multi-center clinical trial that is currently recruiting patients at 100
sites across 20 countries worldwide.
The Cancer Center is seeking patients with advanced prostate cancer that
has spread to the bones to take part in a phase III randomized clinical
trial for Alpharadin (pronounced "Alpha-raydin"), an injectable
treatment based on the radioactive substance Radium-223, an
alpha-particle emitting pharmaceutical. All participants will receive
the best available standard therapy and are randomized so that
two-thirds of the subjects receive Alpharadin in addition. The other
third of subjects will receive placebo along with the standard of care
therapy. Early clinical trials of Alpharadin have suggested that it is
well tolerated and that it might prolong survival for men whose prostate
cancer is no longer responding to hormone therapy and has spread to the
bones.
"Alpharadin appears to work by targeting and destroying cancer cells in
the bone while sparing healthy bone marrow tissue," said Sartor, Piltz
Professor of Cancer Research in the Departments of Medicine and Urology
at Tulane University School of Medicine. "If successful in clinical
trials, this compound could make a significant difference for the large
number of men whose cancer has spread to the bones. Patients most often
die as a consequence of the metastases - not the primary cancer - so
preventing cancer from spreading and controlling cancer that has spread
is a major clinical challenge."
Rest of the story on this web page:
Lud
Sue Mullen
http://www.clinicaltrials.gov/, this phase 111 trial is only at Tulane
here in the USA.
sue
Lud
including little Canada. I am considering it here in Ottawa.
Lud
Sue Mullen
I read, I do not think Kevin would be eligble for this even if it was
available nearby.
At least at Fox Chase Kevin has MDV3100 available if he needs it and
Aberiterone should be available by the end of the year.
sue
Lud
feels that it would knock it down completely - I am finding out more
information.
I was hoping to get on the MDV3200 trial but am ineligible because of
prior Keto - same applies to Abiraterone - it's a bummer some times. I
hope you are right about Abiraterone being approved soon even if I have
to buy it in the USA (I'm in Canada and approvals take longer - most times).
Lud
Sue Mullen
Lud wrote:
> Sadly my hemoglobin is way down 95 to 10 US units and my oncologist
> feels that it would knock it down completely - I am finding out more
> information.
>
> I was hoping to get on the MDV3200 trial but am ineligible because of
> prior Keto - same applies to Abiraterone - it's a bummer some times. I
> hope you are right about Abiraterone being approved soon even if I have
> to buy it in the USA (I'm in Canada and approvals take longer - most
> times).
The reason Kevin is doing Taxotere now instead of Keto is to keep him
eligble for MDV3100 in case the chemo doesn't work or eventually fails
to work.
I am counting on Albiraterone being approved, Kevin's med onc is so
excited about it. Since he is the chief of the department and
responsible for getting the trials, he also keeps close track of what is
going on with them. He gets this grin on his face when he gives us an
update on Albiratrone.lol
WOW, I didn't know that Canada was worse then the US in approving new
drugs.
Good luck to you, this disease sucks big time!!!!!!!!
sue
Steve Kramer
news:hhmc7o$sje$1...@news.eternal-september.org...
> I hope you are right about Abiraterone being approved soon even if I have
> to buy it in the USA (I'm in Canada and approvals take longer - most
> times).
-- skramer remarks
Why do you think that is, Lud? Two obvious possibilities are nationalized
health care and/or importation issues. Do you have a handle on the
reason(s)?
PSA 16 10/17/2000 @ 46
Biopsy 11/01/2000 G7 (3+4), T2c
RRP 12/15/2000 G7 (3+4), T3cN0M0 Neg margins
PSA <.1 <.1 <.1 .27 .37 .75 PSAD 0.19 years
EBRT 05-07/2002 @ 47
PSA .34 .22 .15 .21 .32 PSAD .056 years
Lupron 07/03 (1 mo) 8/03 and every 4 months there after
PSA .07 .05 .06 .09 .08 .132 .145 PSAD 1.4 years
Casodex added daily 07/06
PSA undetectable since. Next Assay 02/02/10
Illegitimati non carborundum
tarhoosier7
> "Lud" <Ludwi...@gmail.com> wrote in message
>
> news:hhmc7o$sje$1...@news.eternal-september.org...
>
> > I hope you are right about Abiraterone being approved soon even if I have
> > to buy it in the USA (I'm in Canada and approvals take longer - most
> > times).
additional supporting trials within the country itself. Not so for the
US which must confirm to the satisfaction of the Food and Drug
Administration with additional US trial(s). This would seem to advance
drug approval in Canada IF there is prior approval in the EU.
Additional info is requested from those more knowledgeable
Heather
"Steve Kramer" <skr...@cinci.rr.com> wrote in message
news:hhnf9j$3u8$1...@news.eternal-september.org...
> "Lud" <Ludw...@gmail.com> wrote in message
> news:hhmc7o$sje$1...@news.eternal-september.org...
>
>> I hope you are right about Abiraterone being approved soon even if I have
>> to buy it in the USA (I'm in Canada and approvals take longer - most
>> times).
>
> -- skramer remarks
>
> Why do you think that is, Lud? Two obvious possibilities are nationalized
> health care and/or importation issues. Do you have a handle on the
> reason(s)?
>
different protocols than the US. HIFU was approved here long before the US
for instance........if it is even approved there now. Our rad onc wasn't
keen on it and he was in on the testing.
I decided to do some searching for Alpharadin and there are a lot of trials
recruiting now....5 in Canada, in fact. 3 of them in Ontario, Lud. Ottawa,
Toronto and London. The Toronto one is at Sunnybrook Hospital, so I will
ask our oncologist about it at the end of February. And I will ask him what
promising ones are out there.
In the US, there is just the Tulane one.
http://www.algeta.com/alsympca/
HTH.........Heather
Steve Kramer
news:hho280$d8r$1...@news.eternal-september.org...
>
> "Steve Kramer" <skr...@cinci.rr.com> wrote in message
> news:hhnf9j$3u8$1...@news.eternal-september.org...
>> "Lud" <Ludw...@gmail.com> wrote in message
>> news:hhmc7o$sje$1...@news.eternal-september.org...
>>
>>> I hope you are right about Abiraterone being approved soon even if I
>>> have to buy it in the USA (I'm in Canada and approvals take longer -
>>> most times).
>>
>> -- skramer remarks
>>
>> Why do you think that is, Lud? Two obvious possibilities are
>> nationalized health care and/or importation issues. Do you have a handle
>> on the reason(s)?
>>
> Without researching for reasons, I can safely say that we just plain have
> different protocols than the US. HIFU was approved here long before the
> US for instance........if it is even approved there now.
-- skramer remarks
HIFU is still considered experimental in the US. I have read that the
reason is that it does not have long-term safety or effectiveness research.
It's not proven to be very effective for people in this NG, but the numbers
are far too small to count them as representative.
Heather
> "Heather" <fer...@canada.invalid> wrote in message
> news:hho280$d8r$1...@news.eternal-september.org...
>>
>> Without researching for reasons, I can safely say that we just plain have
>> different protocols than the US. HIFU was approved here long before the
>> US for instance........if it is even approved there now.
>
> -- skramer remarks
>
> HIFU is still considered experimental in the US. I have read that the
> reason is that it does not have long-term safety or effectiveness
> research. It's not proven to be very effective for people in this NG, but
> the numbers are far too small to count them as representative.
Whoops........forgot to say that while it may be *approved*, it is not paid
for under our healthcare plan. And I believe the going price is around
$20,000 Cdn. So I don't imagine many people are utilizing it. Our
radiation oncologist is a top researcher and Sunnybrook looks into any and
all new treatments out there. He wasn't all that impressed with that
procedure.
If it had been on Ron's list of options, he would NOT have gone for it. Nor
would he go for surgery (at age 70). Our urologist said that his chances
were just as good with radiation. So looking back at the big picture now, I
am glad I didn't try to pressure him into surgery. The horse was already
out of the barn. I imagine he will go back on HT next month.
Heather
Lud
I have an impression. Being a smaller market, drug companies will not do
clinical trials to Canada's requirements. First the drug company has to
submit a request with supporting data (this does not always happen as
with Leukine). This leaves HC reviewing data that was prepared in the
USA or EU - obvious time delay as rarely unapproved drugs by other
jurisdictions are not submitted. Sometimes HC has their own ideas of
safety (thalidomide was not approved here).
Once the drug is approved by HC, each provincial medicare jurisdiction
has to review it and see if they want to pay for it (even under
Medicare, some drugs are not covered so patient pays - eg my Estrogel) -
this is where the cost factor comes in and expensive or not critical
drugs take longer to be accepted under medicare. Sometimes it's
ridiculous - Ontario medicare does not pay for Neulasta but will cover
the patient to be in Hospital for 6 days on IV anti-biotics (neutropenia
from Taxotere) - that was my experience.
Each jurisdiction has their fun and games. As most of my family is
American or dual (I am the only Canuck), I feel I can comment on your
system; Those that have PPI insurance are sitting pretty but the rest
seem terrorized by insurance companies and HMO's. Our doctors are too
busy and don't have enough time but they are readily available and we
don't panic or not go to get healthcare because of financial problems -
only stupidity or ignorance stops some.
Lud
Lud
available for special cases that don't main good options. It is not
promoted as main line PCa treatment.
Lud
J
> Even the doctors doing HIFU say publicly it is not for everyone - it is
> available for special cases that don't main good options. It is not
> promoted as main line PCa treatment.
>
> Lud
<
http://prostatecancerinfolink.net/2010/01/01/what-the-belgian-health-authorities-think-about-hifu/
>
What the Belgian health authorities think about HIFU
Posted on January 1, 2010 by Sitemaster
Quantcast
We have learned that last October the �Federaal Kenniscentrum voor de
Gezondheidszorg� or KCE in Brussels, Belgium (the �Federal Center for Health
Care Knowledge�) published a guidance document on the current use of
high-intensity focused ultrasound (HIFU) for the treatment of localized prostate
cancer.
The authors note the following key points as background to this assessment:
* The optimal treatment for localized prostate tumors is still not clear.
* The standard forms of potentially curative treatnment (radical
prostatectomy and radiotherapy) come with significant complications and risks.
* HIFU appears to be a potential alternative, and has been used (a) as
primary treatment for patients with localized prostate cancer (T1-2N0-xM0; mostly
low and intermediate risk) who are not suitable for surgery and (b) as salvage
treatment for locally proven recurrence of prostate cancer after curative
therapy.
* About 730 patients (0.8 percent of all new prostate cancer patients) were
treated with HIFU at four Belgian hospitals in the years 2000 to 2008.
The authors conducted out a standard literature review, which � they state �
�showed that there is currently not sufficient evidence to support routine use of
this new treatment modality.�
They note that two multicenter, non-randomized, controlled clinical trials
comparing HIFU with cryotherapy and brachytherapy are recruiting patients in the
US with the goal of suppporting FDA approval of HIFU.
However, they conclude by saying that, �Until more evidence becomes available,
KCE recommends [limiting] the use of HIFU� to the clinical trials setting. They
go on to suggest the need for more �comparative studies, preferably randomized
controlled trials.�
Steve Kramer
> So looking back at the big picture now, I am glad I didn't try to pressure
> him into surgery. The horse was already out of the barn. I imagine he
> will go back on HT next month.
-- skramer remarks
The bigger picture, I think, is that he's lasted 6� years and is now pushing
78. When he was born, that probably exceeded by a decade his life
expectancy. He has survived the cancer and socialized medicine very well.
;-)
Steve Kramer
>I don't have direct knowledge of Health-Canada (HC)approval process, but I
>have an impression. Being a smaller market, drug companies will not do
>clinical trials to Canada's requirements. First the drug company has to
>submit a request with supporting data (this does not always happen as with
>Leukine). This leaves HC reviewing data that was prepared in the USA or
>EU - obvious time delay as rarely unapproved drugs by other jurisdictions
>are not submitted. Sometimes HC has their own ideas of safety (thalidomide
>was not approved here).
>
> Once the drug is approved by HC, each provincial medicare jurisdiction has
> to review it and see if they want to pay for it (even under Medicare, some
> drugs are not covered so patient pays - eg my Estrogel) - this is where
> the cost factor comes in and expensive or not critical drugs take longer
> to be accepted under medicare. Sometimes it's ridiculous - Ontario
> medicare does not pay for Neulasta but will cover the patient to be in
> Hospital for 6 days on IV anti-biotics (neutropenia from Taxotere) - that
> was my experience.
Thanks. That was educational.
Steve Kramer
> Even the doctors doing HIFU say publicly it is not for everyone - it is
> available for special cases that don't main good options. It is not
> promoted as main line PCa treatment.
-- skramer remarks
That makes sense. Whenever I read of HIFU, it is listed in the primary care
sections of documents and books. However, you make a good argument for it
being listed as a specialty. Not too many treatments for PCa are available
for primary, salvation, and repeated treatments.
Lud
.......
> * HIFU appears to be a potential alternative, and has been used
(a) as
> primary treatment for patients with localized prostate cancer
(T1-2N0-xM0; mostly
SALVAGE TREATMENT
> for locally proven recurrence of prostate cancer after curative
> therapy.
This was the view expressed by the doctor at the Maple Leaf HIFU centre
(MY CAPS).
Lud
Heather
> "Heather" <fer...@canada.invalid> wrote in message
> news:hhor9d$hg6$1...@news.eternal-september.org...
>
>> So looking back at the big picture now, I am glad I didn't try to
>> pressure him into surgery. The horse was already out of the barn. I
>> imagine he will go back on HT next month.
>
>
> -- skramer remarks
>
> The bigger picture, I think, is that he's lasted 6� years and is now
> pushing 78. When he was born, that probably exceeded by a decade his life
> expectancy. He has survived the cancer and socialized medicine very well.
> ;-)
Nah, you have it backwards......he survived it well BECAUSE we have
socialized medicine and also he was in a trial. Sure baffled the lead
oncologists tho with his meteoric PSA rise back in 2004. I suppose it is
about 3.0 at the moment.
I was just reading up on Dr. Loblaw's latest papers at Pubmed to see what is
new. Think I will access Ron's records at the hospital to see if the doc is
making any notes to himself about his upcoming appt.
Oh yes.....in his British side of the family, life expectancy is mid 80's to
mid 90's, so think he has a few good years left.
Bloody cold here today........minus 24C with the windchill!!
Cheers from Iceland......Heather