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Medical Forum / Diseases and Disorders / Prostate Cancer / March 2005

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Palladium-based prostate cancer treatment proves effective

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c palmer - 07 Mar 2005 22:08 GMT
- 7th March 2005


A new palladium-based prostate cancer treatment has been shown to
deliver a marked improvement in comparison with traditional remedies.

A peer-reviewed 12-year study of brachytherapy using palladium-103
indicates that the treatment is superior to prostatectomy and that "seed
therapy" is a viable alternative.

The study concerns the treatment of high- and intermediate-risk prostate
cancer patients, and is published in the latest edition of the journal
Brachytherapy.
Medical firm Theragenics found that those high-risk patients treated
with "seeding" - a minimally invasive procedure harnessing palladium-103
- had an 88 per cent cure rate, far above the standard 43 per cent cure
rate obtained with surgery.
Ms M. Christine Jacobs, president of Theragenics, said that the findings
of the study led by Dr Jerrold Sharkey confirmed that "treatment with
the TheraSeed device can offer patients a greater chance for a complete
life regardless of risk factor".

"This new clinical study, once again, proves the efficacy of
brachytherapy and further reinforces the long-term success rates of our
TheraSeed (palladium-103) device," she added.

This study retrospectively reviewed data on 1,707 prostate cancer
patients, treated from 1992 to 2004, at the Urology Health Centre in the
Greater Tampa area in the US.

© 1998-2005 DeHavilland Information Services plc.

knowledge is power - growing old is mandatory - growing wise is optional    
"Many more men die with prostate cancer than of it. Growing old is
invariably fatal. Prostate cancer is only sometimes so."
http://community.webtv.net/PALMER_ENT/doc
Beverley - 08 Mar 2005 03:15 GMT
Yippee!!
Bev

- 7th March 2005

A new palladium-based prostate cancer treatment has been shown to
deliver a marked improvement in comparison with traditional remedies.

A peer-reviewed 12-year study of brachytherapy using palladium-103
indicates that the treatment is superior to prostatectomy and that "seed
therapy" is a viable alternative.

The study concerns the treatment of high- and intermediate-risk prostate
cancer patients, and is published in the latest edition of the journal
Brachytherapy.
Medical firm Theragenics found that those high-risk patients treated
with "seeding" - a minimally invasive procedure harnessing palladium-103
- had an 88 per cent cure rate, far above the standard 43 per cent cure
rate obtained with surgery.
Ms M. Christine Jacobs, president of Theragenics, said that the findings
of the study led by Dr Jerrold Sharkey confirmed that "treatment with
the TheraSeed device can offer patients a greater chance for a complete
life regardless of risk factor".

"This new clinical study, once again, proves the efficacy of
brachytherapy and further reinforces the long-term success rates of our
TheraSeed (palladium-103) device," she added.

This study retrospectively reviewed data on 1,707 prostate cancer
patients, treated from 1992 to 2004, at the Urology Health Centre in the
Greater Tampa area in the US.

? 1998-2005 DeHavilland Information Services plc.

knowledge is power - growing old is mandatory - growing wise is optional
"Many more men die with prostate cancer than of it. Growing old is
invariably fatal. Prostate cancer is only sometimes so."
http://community.webtv.net/PALMER_ENT/doc
Tom Cular - 08 Mar 2005 10:35 GMT
Sounds encouraging to me, I've had the Pd103 seeds since June 04.
Tom
> Yippee!!
> Bev
[quoted text clipped - 34 lines]
> invariably fatal. Prostate cancer is only sometimes so."
> http://community.webtv.net/PALMER_ENT/doc
ron - 08 Mar 2005 22:36 GMT
> A peer-reviewed 12-year study of brachytherapy using palladium-103
> indicates that the treatment is superior to prostatectomy and that "seed
> therapy" is a viable alternative.

While I agree that seeds are a viable treatment methodology, I think it
is a bit of a stretch for the authors to conclude that it is superior
to RP (if in fact they really do make such a claim, it might just be
the medias mis-statement; I don't see such a claim in the abstract).
The authors use different definitions of failure for seeds (ASTRO) and
RP (PSA > 0.4 ng/ml).  As I've mentioned before, it's the same as
saying that 100F is a higher temperature than 80C.  If the author's
assertions are correct, it is due to chance and not scientific
evidence...Best wishes and good health, Ron

(103)Pd brachytherapy versus radical prostatectomy in patients with
clinically localized prostate cancer: A 12-year experience from a
single group practice.

Sharkey J, Cantor A, Solc Z, Huff W, Chovnick SD, Behar RJ, Perez R,
Otheguy J, Rabinowitz R.

Urology Health Center, New Port Richey, FL.

PURPOSE: In an effort to shed light on the continuing debate over the
best treatment options for patients with localized prostate cancer, we
present a retrospective review of patients from a single group
community urology practice.
METHODS AND MATERIALS: Data from 1707 patients were reviewed. These
patients, with T1 or T2 adenocarcinoma of the prostate, were treated
from 1992 to 2004 with either brachytherapy or radical retropubic
prostatectomy (RRPP); 81% were aged over 65 years. Patients were
classified into risk groups based on initial prostate-specific antigen
(PSA) and Gleason score. Time to PSA-indicated recurrence was used as
the measure of disease control and cure.
RESULTS: Time to PSA-indicated recurrence was used as a measure of
efficacy. Brachytherapy with (103)Pd exclusively and RRPP were found to
provide equivalent control (<0.4 ng/mL for prostatectomy and <3
successive rises in PSA as defined by the American Society for
Therapeutic Radiology and Oncology [ASTRO]) in low-risk groups (89%
seeds vs. 94% RRPP). In intermediate (89% seeds vs. 58% RRPP) and
high-risk (88% seeds vs. 43% RRPP) groups, brachytherapy patients had
better control rates. The addition of external radiation, with or
without luteinizing hormone-releasing hormone therapy, improved
biochemical control rates in intermediate and high-risk brachytherapy
groups.
CONCLUSION: The results failed to show any superiority of prostatectomy
over brachytherapy with (103)Pd (TheraSeed; Theragenics Corp., Buford,
GA) regarding time until relapse as indicated by PSA level increase
(>0.4 ng/mL for prostatectomy and >3 successive rises in PSA as defined
by ASTRO). We recently reviewed our techniques and improved equipment
from 1995 to present and found major gains with both brachytherapy and
surgery. Low risk brachytherapy resulted in 99% freedom from PSA
failure while surgery showed results of 97%. Brachytherapy and
prostatectomy should be offered without bias to all men with stage T1
and T2 organ-confined prostate cancer.
Beverley - 11 Mar 2005 19:59 GMT
Here's the problem - they keep comparing apples to oranges. But what several
studies are showing is that when the cancer is caught early enough, thanks
to early PSA testing, brachytherapy is showing the same or slightly better
odds with early PC. What still is not clear is if the PC is more advanced
then does brachytherapy therapy do as well as RP? And how do they know if
this Gleason 6 is more advanced than that Gleason 6? Are palladium-103's
better than Iodine 125's? What happens when you toss some external beam into
the picture just to be absolutely certain? (Theraseed has spent a great deal
of money pushing their seeds on the public and on the doctors.) And we get
down to the skill of the doctor and the math of the physicist working with
the doctor plus the individual patient. I've been out here long enough to
see that many docs do not check for seed placement a few weeks down the
road. They might check a few days but not a weeks after seeding. What if
someone throws a seed? How much of the prostate is not fried?

In all fairness to the RP many questions can be asked of the surgery. How
much prostate tissue is left behind? Is robotic better than LRP for removing
the prostate? What about that surgeon's skill? How do they know they got it
all? (Don't say clean margins because that is only an indicator not an
absolute.)

No, there is no perfect treatment. If there was everybody would be using the
same treatment.

In the next to the last statement you copied it stated "Low risk
brachytherapy resulted in 99% freedom from PSA failure while surgery showed
results of 97%." Sure looks like slightly better odds but I'm also sure that
Leonard can explain that any study showing odds has a +/- percentage. So
really what is the difference between 99 and 97? Not much if there is real
difference. Where as the difference between 86 and 96 would definitely show
a truer difference in treatment.

And the final statement is probably the best. "Brachytherapy and
prostatectomy should be offered without bias to all men with stage T1 and T2
organ-confined prostate cancer." Both are perfectly good treatments for
prostate cancer. This allows men to choose their treatment based on other
factors such as doctor skill, convenience and their own personal feelings.
The last thing any man needs is to be railroaded into a particular type of
treatment. We all know there are lots of SE's to any treatment so it's a
matter of choosing your poison. What are you willing to risk? They both work
for early stage PC.
Bev

> > A peer-reviewed 12-year study of brachytherapy using palladium-103
> > indicates that the treatment is superior to prostatectomy and that
[quoted text clipped - 52 lines]
> prostatectomy should be offered without bias to all men with stage T1
> and T2 organ-confined prostate cancer.
ron - 11 Mar 2005 20:36 GMT
> Here's the problem - they keep comparing apples to oranges.

Exactly, and you can't meaningfully compare apples and oranges.

> But what several
> studies are showing is that when the cancer is caught early enough, thanks
> to early PSA testing, brachytherapy is showing the same or slightly better
> odds with early PC.

No!  That's the apples and oranges point!  The brachytherapy odds of
success are being measured with a different definition of success
(ASTRO) compared to surgery (PSA>0.2).  For example, according to
ASTRO, 3 consecutive PSA rises measured 6 months apart define a
failure.  So at 17 months post-RT there can be no failures using the
ASTRO DOF, 100% treatment success!  Whereas with RP, there will be some
failures at 17 months because only a single PSA>0.2 is needed to call a
case reccurrent.  Published reports show that when the exact same
population is measured by the ASTRO and by the PSA>0.2 DOFs, the
success rate using the ASTRO DOF is always 8-40 percentage points
higher than the RP success rate; whereas since we are measuring the
same population they must, in fact, be equivalent.  This is the
apples-oranges fallacy.  Again this is like saying 100F is hotter than
80C, such comparisons of measurements using two different definitions,
of disease recurrence or, temperature, are erroneous, unless
fortuitously, by luck, they happen to coincide.

> What still is not clear is if the PC is more advanced
> then does brachytherapy therapy do as well as RP? And how do they know if
> this Gleason 6 is more advanced than that Gleason 6? Are palladium-103's
> better than Iodine 125's?

An interesting analysis was done for SI by separating the low, medium
and high risk groups by isotope. Low risk PSA-BFS was 86% for those
treated with I-125 and 100% for those treated with Pd-103; intermediate
risk, 78% for I-125 and 88% for P-103, and high risk; 67% for I-125 and
64% for P-103

> What happens when you toss some external beam into
> the picture just to be absolutely certain? (Theraseed has spent a great deal
> of money pushing their seeds on the public and on the doctors.)

In this caes [SI+EBRT], RCOG uses PSA>0.2 ng/ml as their DOF and direct
comparison with surgery can be done.  The two treatments look
equivalent over the various risk groups.

> And we get
> down to the skill of the doctor and the math of the physicist working with
> the doctor plus the individual patient. I've been out here long enough to
> see that many docs do not check for seed placement a few weeks down the
> road. They might check a few days but not a weeks after seeding. What if
> someone throws a seed? How much of the prostate is not fried?

As I've asked before, how many RT patients have looked at their D90s,
to see if there are cold spots in their treatment?  The surgeon leaves
some cancerous tissue behind, the radiologist has a cold spot.

> In all fairness to the RP many questions can be asked of the surgery. How
> much prostate tissue is left behind? Is robotic better than LRP for removing
> the prostate?

As to LRP and robotic, here is a very recent comment from Dr.
Guillonneau, the founder of the laparscopic technique for PCa teatment:
"These results justify the considerable interest of the urological
community in laparoscopy, as evidenced by its widespread application.
Nevertheless, longer followup and more mature data are needed
definitively to establish laparoscopic radical prostatectomy as an
alternative to the retropubic approach."  At this time, Dr. Guillonneau
does not know if LRP is better, equal or worse than open RP in terms of
long-term freedom from disease recurrence.

> What about that surgeon's skill? How do they know they got it
> all? (Don't say clean margins because that is only an indicator not an
[quoted text clipped - 6 lines]
> brachytherapy resulted in 99% freedom from PSA failure while surgery showed
> results of 97%." Sure looks like slightly better odds

Nope, it's tha apples-oranges thing once again.  A meaningful
scientific comparison cannot be made in this case.

> but I'm also sure that
> Leonard can explain that any study showing odds has a +/- percentage. So
[quoted text clipped - 12 lines]
> for early stage PC.
> Bev

Bev...No argument on this, RT and RP are viable treatments as evidenced
by the numbers of men who select them.  What I don't know is whether RT
is better, equal or worse than RP because the data for an
apples-to-apples comparison is not available today...Best wishes and
good health, Ron

> > > A peer-reviewed 12-year study of brachytherapy using palladium-103
> > > indicates that the treatment is superior to prostatectomy and that
[quoted text clipped - 52 lines]
> > prostatectomy should be offered without bias to all men with stage T1
> > and T2 organ-confined prostate cancer.
Beverley - 16 Mar 2005 03:57 GMT
Ummm!

100F is hotter than 80C?  I don't thinks so, 80C should be about 194F. And
I'd say that is much hotter.

A good brachy doc will check for cold spots. My husband had a 97% intense
coverage, they want 94% to assure a total kill.
Bev

> > Here's the problem - they keep comparing apples to oranges.
>
[quoted text clipped - 126 lines]
> apples-to-apples comparison is not available today...Best wishes and
> good health, Ron
ron - 16 Mar 2005 16:42 GMT
> Ummm!
>
> 100F is hotter than 80C?  I don't thinks so, 80C should be about 194F. And
> I'd say that is much hotter.

Yes Bev, that is exactly the point I was trying to make.  Just as you
can't directly compare temperatures using different scales (such as
fahrenheit and centigrade), you can't directly compare biochemical
disease freedom rates (BDFR) using different scales (such as ASTRO and
PSA>0.2 ng/ml).  It makes no more sense to say that since treatment A
has a BDFR of 85% using ASTRO and treatment B has a BDFR of 85% using
PSA>0.2 ng/ml, the two treatments produce equivalent outcomes, as it
does to say that 100C and 100F are equivalent...Best wishes and good
health, Ron
Beverley - 17 Mar 2005 02:06 GMT
I totally disagree.

If something is "x" amount of hot, then that is how hot it is. It doesn't
matter if you measure it in centigrade or in Fahrenheit. It's still "x" hot.
Just because freezing is 32 F or 0 C it is still freezing!

The object of radiation treatments is to kill the cancer. In the case of
brachytherapy they also kill the prostate. So the difference is to produce a
PSA that says there is no cancer left. I think we can all agree that the
definition of failure is a rise in PSA and more distinctly I believe they
say a climb 3 times in a row. With that understanding it really does not
matter if the PSA drops to 0.14 and stays there or if it drops to <0.1 and
stays there. The object is to drop it to a low number and have it stay put.
The difference is the treatments will differ in the amount of time it takes
to see that low number. In the case of brachytherapy they want to see the
number fall to at least 0.2 by the second year. We are hoping that this year
we just might see <0.1 at the three year mark. (Hubby was at exactly 0.10 at
2.5 years) A RP'er would be panic stricken if he had to wait 3 years to see
his PSA fall that low. At what number will my husband's PSA drop to it's
lowest point? We don't know but what is important is that it does not begin
to climb.

But let's say a brachytherapy patient sees a climb in PSA. That just meant
they didn't get all the cancer, it escaped (or metastasized) prior to
treatment. Let's say a RP patient sees a climb in PSA after his treatment -
same thing, they didn't get it all at the time of treatment. So failure is
failure. If after the RP there is a climb they radiate the prostate bed. If
after brachytherapy there is a failure they radiate the prostate bed unless
of course they already radiated the prostate bed directly prior to or right
after seeding. Which would be the same as having a RP and radiating the
prostate bed. And we all know that once the prostate has been removed and
the bed radiated the only thing left is hormone treatment/chemo etc., so it
is for the brachy patient who has already had the prostate bed radiated
along with their seeding. So failure is failure, the PSA begins to rise
because the cancer escaped from the prostate prior to treatment. So no, they
are not the same treatments. Their are differences. But the outcome is the
same destroy the caner either by removing it or frying it.

Someone who has had just RT is not going to see the PSA fall as low as
someone with brachytherapy. They might hang out for the rest of their lives
with a 1.08 and that is fine as long as it stays there. Their prostate can
rebuild itself. (There are only a few organs that are capable of
regeneration and the prostate is one of them.) So I would say it is very
difficult to compare RT (only) against RP but it is very easy to compare
brachy against RP - it just takes longer to see the results.
Bev

> > Ummm!
> >
[quoted text clipped - 11 lines]
> does to say that 100C and 100F are equivalent...Best wishes and good
> health, Ron
ron - 17 Mar 2005 02:55 GMT
Bev wrote...snip...
So I would say it is very difficult to compare RT (only) against RP but
it is very easy to compare brachy against RP - it just takes longer to
see the results.
---------------------------------------------------------------------------------------------------------------------------------------
Bev...I probably haven't explained my point very well.  Let me try one
more example.  Suppose we take a large number of men with PCa and treat
them with surgery, then we watch men biochemically fail over a 10 year
period.  If we measure failure by the ASTRO definiton we would find
that 22% of the men had failed by 10 years.  On the other hand, if we
measure biochemical failure using PSA>0.2 ng/ml as the DOF we would
find that 57% of the men had failed.  Which number is correct?  The
point is ASTRO and PSA>0.2 ng/ml DOFs cannot be directly compared.  In
this example (Defining prostate specific antigen progression after
radical prostatectomy: what is the most appropriate cut point?; J Urol.
2001 Apr;165(4):1146-51; Amling CL, Bergstralh EJ, Blute ML, Slezak JM,
Zincke H.)  ASTRO confers a 35 point advantage.  ASTRO always shows
better disease freedom than PSA>0.2.  I don't know which DOF is a
better descripter of reality, I just know that results from a study
using ASTRO cannot be compared to results from a study using PSA>0.2 as
the DOF.

A similar example using SI+EBRT instead of surgery can be found in, "A
standard definition of disease freedom is needed for prostate cancer:
undetectable prostate specific antigen compared with the American
Society of Therapeutic Radiology and Oncology consensus definition"; J
Urol. 2002 Mar;167(3):1310-3; Critz, FA

If my example didn't clarify the issue, try reading the two articles
I've cited.  I'm sure Critz and Zincke explain the concept much better
than I did...Best wishes and good health, Ron
 
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