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

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Brachytherapy with Palladium-103 Better Than or Equal to Prostatectomy??

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Bob Anthony - 14 Mar 2005 20:32 GMT
I'm wondering if this doctor is "in bed" with Theragenics....read below:

Prostate Cancer - Brachytherapy with Palladium-103 Better Than or Equal
to Prostatectomy
08 Mar 2005

Twelve-Year Research Proves Superior Efficacy of “Seed Therapy” for
High- and Intermediate-Risk Prostate Cancer Patients -

A new peer-reviewed study demonstrates that cure rates achieved with
brachytherapy using palladium-103 are better than or equal to
traditional surgery for treating prostate cancer. The twelve-year study
proves the superior efficacy of brachytherapy, or “seed therapy,” for
treatment of high- and intermediate-risk prostate cancer patients. The
study is published in the Vol. 4, Issue 1 edition of the journal
Brachytherapy and is now available online at
sciencedirect.com/science/journal/15384721.

Key findings of the study reveal that high-risk prostate cancer patients
treated with brachytherapy using palladium-103 experienced greater
success than patients treated with prostatectomy. In fact, high-risk
patients treated with seeding showed an 88% cure rate vs. a 43% cure
rate obtained with surgery at 12 years. Similarly, the results for
intermediate-risk patients were also impressive, with 12-year data
reflecting a success rate of 89% with seed therapy vs. a 58% success
rate with surgery. In addition, low-risk patients demonstrated
comparable results with those treated with seeds experiencing a 99%
success rate vs. a 97% success rate with surgery at 10 years. *

The study, “Palladium-103 Brachytherapy Versus Radical Prostatectomy in
Patients with Clinically Localized Prostate Cancer: A 12-Year Experience
From A Single Group Practice,” was conducted by Jerrold Sharkey, M.D.,
Clinical Research Director of the Urology Health Center and Advanced
Research Institute in New Port Richey (Greater Tampa area), FL, and
Clinical Assistant Professor of Urology at the University of South Florida.

This study retrospectively reviewed data on 1,707 prostate cancer
patients, treated from 1992 to 2004, at the Urology Health Center. All
patients were diagnosed with localized cancer that had not extended
outside of the prostate gland. Of the 1,707 study participants, 1,380 -
or more than 80% - were treated with seed therapy; the others were
treated with surgery.

All brachytherapy patients in the study were treated exclusively with
the palladium-103 device TheraSeed®, manufactured by Brachytherapy with
Palladium-103 Better Than or Equal to Prostatectomy Corporation®.
Independent clinical studies demonstrate that the palladium composition
of the TheraSeed® device acts faster, and results in significantly fewer
complications, than iodine-based seeds.

"This new clinical study, once again, proves the efficacy of
brachytherapy and further reinforces the long-term success rates of our
TheraSeed® (palladium-103) implants,” stated Ms. M. Christine Jacobs,
Chairman, CEO and President of Theragenics™. "Dr. Sharkey's findings
also confirm that treatment with the TheraSeed® device can offer
patients a greater chance for a complete life regardless of risk factor."

“This twelve-year study demonstrates that brachytherapy should be
offered without bias to all men with early organ-confined (stage T1 and
T2) prostate cancer,” said Dr. Sharkey. “It is, of course, important
that the seed implants be performed with meticulous attention to
technique by an experienced team of radiation oncology and urology
specialists.”

There is a growing trend of treating prostate cancer with brachytherapy.
A 2003 membership study of urologists' practice patterns conducted by
the Gallup Organization found that more urologists are performing seed
therapy for prostate cancer. According to the study, seed therapy has
increased from 16% in 1997 to 56% in 2003.

Brachytherapy is a form of radiation therapy that fights prostate cancer
with rice-sized radioactive seeds implanted inside the body. A minimally
invasive outpatient procedure, it is associated with a lower risk of
quality of life implications, such as incontinence and impotence.

Dr. Sharkey's research results reflect outcomes generated by his group
practice of six urologists (Drs. Raymond Behar, Stanley Chovnick, Ramon
Perez, Juan Otheguy and Richard Rabinowitz), as well as radiation
therapy colleague Dr. Zucel Solc and radiation physicist Dr. William
Huff. Dr. Sharkey has authored numerous peer-reviewed articles published
in Urology, Journal of Endourology, and Current Urology Reports.

The American Brachytherapy Society publishes Brachytherapy, an
international and multidisciplinary journal that provides original
peer-reviewed articles and selected reviews about the techniques and
clinical applications of interstitial radiation, endovascular radiation,
endovascular brachytherapy and systemic brachytherapy in the management
of cancer, and cardiac and other diseases.
ronju99 - 15 Mar 2005 00:11 GMT
The US Food & Drug Administration approved marketing of the Palladium-103
in July 1998. That was seven years ago.
c palmer - 15 Mar 2005 01:27 GMT
hi bob - i posted an article about the pd-103 a couple of weeks ago and
it was using the same company's report.

the bottom line is simply this and this is right where the rubber hits
the road.

regardless where a person has type of surgery or has any type of
radiation, the numbers are almost the same for having recurrence of
prostate cancer.  they are 50% chance within 3 years,  80% chance within
5 years and 99% chance within 10 years.  

most of the trial studies talk about a 10 year survival rate, not a 10
year cancer free rate.

here's food for thought though.

when a person has surgery and they have recurrence of pca, is it because
they didn't get all the cancer at the time of surgery?  i'm meeting with
my surgeon on this wednesday and that is one of the exact questions i'm
putting to him point blank.  he's a great guy and hasn't side step any
question i've ever ask him, so it will be interesting to see what his
reply will be.

when a person has radiation and they have recurrence of pca,  since they
didn't get their prostate removed, why is the pca becoming active again?
one of the theories is that the radiation kills the pca cells but does
the extra radiation cause the good prostate cells to change over to pca
cells at a later time.

i've not heard or read much in this area.  it seems like if they could
do research as to what causes the recurrence since we are suppose to be
"cancer free" at the time after treatment.

as i said, just a thought to kick around.

~ curtis

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
ron - 15 Mar 2005 02:37 GMT
c palmer wrote:...snip...
> hi bob - i posted an article about the pd-103 a couple of weeks ago and
> it was using the same company's report.

Yes, Bob's post was the third time this article has been posted.  As I
mentioned in the two earlier posts, this article, or at least the
various newsfeed renditions of it, are impressively misinformational.

> regardless where a person has type of surgery or has any type of
> radiation, the numbers are almost the same for having recurrence of
> prostate cancer.

Other than for SI+EBRT and RP where a direct comparison, with the same
definition of failure (DOF), can be made, I am unaware of any other
work that shows that RT and RP have similar outcomes when using the
same DOF.  Please provide a reference if I've missed something.

> they are 50% chance within 3 years,  80% chance within
> 5 years and 99% chance within 10 years.

I assume you've mistyped (or I am misunderstandaing) something here
Curtis.  99% chance of recurrence at 10 years, no way.  It's the other
way around, for RP with low-risk men at Hopkins the chances of being
biochemically disease free at 10 years is >90%

> most of the trial studies talk about a 10 year survival rate, not a 10
> year cancer free rate.

Actually they talk about both, but 10 year biochemical freedom from
disease is what is most commonly discussed since biochemical recurrence
occurs over a shorter period of time than disease specific survival.
In other words, it takes a lot longer for people to die of PCa than to
recur, so recurrence is easier to measure over the short time period
used in most studies.

> here's food for thought though.
>
> when a person has surgery and they have recurrence of pca, is it because
> they didn't get all the cancer at the time of surgery?

It is either because the disease was already systemic prior to surgery
or the surgeon left too much behind.

> when a person has radiation and they have recurrence of pca,  since they
> didn't get their prostate removed, why is the pca becoming active again?

Same reasons, the disease was either already systemic or the rad onc
missed a spot or, as you mention below, maybe it is a radiation induced
second cancer.  The odds of radiation-induced secondary cancers is 1 in
70 at 10 years for cancers around the prostate.

> one of the theories is that the radiation kills the pca cells but does
> the extra radiation cause the good prostate cells to change over to pca
[quoted text clipped - 3 lines]
> do research as to what causes the recurrence since we are suppose to be
> "cancer free" at the time after treatment.

Who said anyone is cancer free after treatment?  No one knows if you
are cancer free or not.  Recurrence can occur out beyond 20 years
post-treatment.  When you die of something else, your family will be
able to say, "the prostate cancer didn't get him."...Best wishes and
good health, Ron
Bob Anthony - 15 Mar 2005 03:43 GMT
they are 50% chance within 3 years,  80% chance within
> 5 years and 99% chance within 10 years.Man...I was (or still) going for
the bottle of scotch! Hopefully, Curtis, it was a typo!!
Signature

Bob Anthony / R A P Marketing Services

c palmer - 15 Mar 2005 05:12 GMT
Other than for SI+EBRT and RP where a direct comparison, with the same
definition of failure (DOF), can be made, I am unaware of any other work
that shows that RT and RP have similar outcomes when using the same DOF.
Please provide a reference if I've missed something.
============hi ron - the head of indiana university medical division gave a
presention that reflected a simliar number on what i posted.  i was
shocked when first heard these numbers.

i challenge the numbers from I.U but he said they were correct.  i'm
thinking that maybe it is in the wording........OF the ones who get
recurrence of prostate cancer do so in this time frame.

dr. catalona is one of the leading surgeons in the united states and has
very extrensive knowledge of prostate cancer.

this is a response to a questions posed to him and also an article on
radiation.

~ curtis

===================
Q:  TIME TO RECURRENCE AFTER RADICAL PROSTATECTOMY:What is the most
usual time frame for psa evidence of recurrent cancer after a radical
protatectomy? I had heard 18 months is the most common time to see this.
A:   Of men who have recurrence, approximately 50% have it within 3
years, 80% withing 5 years and 99% within 10 years.
===========New Results for Postoperative Radiotherapy
By William J. Catalona, MD  

Several previous articles in QUEST and on the drcatalona.com website
address
postoperative radiotherapy, but recent reports have increased our
knowledge, and
this article supplements those previous ones.

History
In the past, we, and other researchers, analyzed 4-year studies of the
effect of postoperative radiotherapy on recurring prostate cancer after
a radical prostatectomy. The figures looked pretty good, and we
reported, with some optimism, that postoperative radiotherapy worked in
saving lives.
It has become clear from recent studies that some patients are far more
likely to benefit from postoperative radiotherapy than others, depending
upon the particular features of their tumor, their PSA level at the time
of treatment, and the dose and technique of radiotherapy used.
For instance, favorable features would be a low PSA level at the time of
treatment, a more slowly rising PSA level, a lower Gleason grade, and a
higher dose of radiation.
Unfavorable features would be the presence of seminal vesicle invasion,
lymph node metastases, a high and/or rapidly rising PSA, and a high
Gleason grade. The presence of positive surgical margins has been found
to be a favorable feature in some studies but not others.
Also, the duration of follow-up affects the results of postoperative
radiotherapy. With longer follow-up, more patients are found to relapse.
Thus, the results of postoperative radiotherapy are strongly influenced
by the patient mix. In series of patients who are selected with
favorable features, postoperative radiotherapy is more successful than
in those that include patients with unfavorable features. However, many
patients have mixed features.
In the past, some physicians have felt that patients having certain
adverse features such as lymph node metastases, seminal vesicle
invasion, very high Gleason grade, or a persistently detectable or
rapidly rising PSA after surgery should not be treated with
postoperative radiotherapy.
Rather, hormonal therapy would be deemed more appropriate, because these
patients would have a high likelihood of having distant metastases.
Furthermore, to date there is no proof that postoperative radiotherapy
can reduce the ultimate incidence of distant metastases or improve
survival.
Recent studies have shed some new light on this controversial area of
prostate cancer treatment. Although the results differ from study to
study, part of the reason for these differences lie in the types of
patients included, the radiation techniques used, and the length of
follow-up.
Adjuvant and Salvage
Postoperative radiotherapy has two categories: adjuvant and salvage.
Adjuvant is preventive treatment closely following a radical
prostatectomy. It is recommended after surgery reveals adverse
pathologic findings that indicate a likely spread of the cancer beyond
the prostate gland but, at the same time, the patient has an
undetectable PSA.
Salvage radiotherapy is the treatment recommended when, after a RRP and
upon follow-up testing, a patient has a rising PSA. It has been thought
that salvage radiotherapy has the potential to cure patients with cancer
recurrence after radical prostatectomy.
Stephenson Study
A recent journal article, (Stephenson, JAMA 2004) being read by doctors
with a great deal of interest, reported on patients they had followed
for almost four years to watch the effects of postoperative
radiotherapy.
Because doctors are using the information, I think our readers should be
familiar with it.
In that 4-year period, approximately 50% of patients who received
salvage radiotherapy for a rising PSA after radical prostatectomy showed
further cancer progression; 10% developed distant metastases, and 4%
died of prostate cancer.
Factors other than a rising PSA figured into the results. Progression
was more likely to occur in men with a Gleason score of 8 or more, a PSA
level of 2 or higher before radiotherapy, negative surgical margins, a
PSA doubling time of 10 months or less after a RRP, or seminal vesicle
involvement.
The idea that negative surgical margins might be a factor in prostate
cancer progression is a paradoxical finding. The proposed explanation is
that patients with positive margins are more likely to have a tumor
recurrence within the bed of the prostate; whereas, those with negative
margins are more likely to have a distant recurrence. However, I am not
convinced of this explanation, and our data does not confirm it.
Among patients with none of these adverse features present, 77% with a
rising PSA after RRP remained free of cancer progression for 4 years.
And some patients with only one adverse finding fared surprising well.
For instance, 64% of men with a rapid PSA doubling time remained free of
recurrence for 4 years if their Gleason grade was 7 or less and their
surgical margins were positive.
Also, patients with a Gleason score of 8 or higher had a progression
free survival of 81% if they were treated early, had a PSA doubling time
longer than 10 months and positive surgical margins.
Therefore, some patients with high-grade cancer and/or a rapid PSA
doubling times who were previously thought to be destined to develop
metastases may respond well to radiotherapy, at least for a 4-year
period.
If Stephenson is correct, some patients with recurring prostate cancer
can be optimistic that postoperative radiotherapy might, at least,
postpone the spread of CaP.
Longer Study
Recently, my research group (including Dr. Misop Han, Jonathan
Rubenstein, and Kimberly Roehl) updated our results analyzing the
effects of postoperative radiotherapy with a longer follow-up, projected
10-year outcomes.
We found a significant decrease in progression-free rates with these
longer follow-ups. In other words, the postoperative radiotherapy might
not have worked as well as we thought.
In the salvage treatment setting that was recommended because of a
rising PSA, we evaluated 307 patients.
Overall, PSA levels fell to undetectable in 73% of patients after
radiotherapy. We observed favorable responses more often in men without
seminal vesicle invasion and in those with a lower PSA at the time of
treatment.
However, we did not confirm better response rates in men with positive
surgical margins. In this finding, our results conflict with
Stephenson's.
With long-term follow-up, though, only 25% of all patients had lasting
responses to salvage radiotherapy. (The 5-year response rate was 55% and
10-year rate was 35%.) It is important to note, however, that many
patients with long-term follow-up were treated with older radiotherapy
methods that are not as effective as those currently in routine use.
One of our conclusions is that we need more studies to answer an
important question: Is postoperative radiotherapy deterring the spread
of prostate cancer? In other words, how many patients would follow the
same time-line with or without the postoperative radiotherapy?
In patients treated with adjuvant radiotherapy (adverse pathologic
findings but an undetectable PSA), the results were that 78% were free
of recurrence at 5 years and 64% at 10 years. In matched patients who
did not receive adjuvant radiotherapy, 75% were recurrence free at 5
years and 50% at 10 years. Thus, there appears to be a distinct benefit
for adjuvant radiotherapy with long-term follow-up.
Controversies
A current controversy is taking place over whether all men with adverse
pathologic findings after radical prostatectomy should automatically
receive adjuvant radiotherapy if their PSA levels become undetectable
after surgery ,or whether they should follow their PSA levels and
receive radiotherapy only if the PSA begins to increase.
In women with breast cancer, for which there is no sensitive tumor
marker such as PSA; adjuvant radiation and chemotherapy are routinely
given if the surgery reveals adverse findings. Thus, all such women
would be treated as though they would have cancer progression without
further treatment.
However, with prostate cancer, the PSA test provides a sensitive marker
for persistent cancer, and the results of treatment appear to be nearly
as good if the radiotherapy is given when the PSA just begins to rise.
Delaying therapy until the PSA rises can avoid unnecessary treatment in
some patients; however, waiting until the PSA is higher than 2 ng/ml can
compromise results.
Another controversy exists about whether patients with very high-risk
tumors should receive hormonal therapy in conjunction with postoperative
radiotherapy, and, if so, for how long should it be continued.
Studies in patients treated primarily with radiotherapy (without
surgery) have shown that patients with high risk tumors respond better
if they receive hormonal therapy beginning before and continuing for two
years after radiotherapy.
However, it is not known if prolonged hormonal therapy is needed with
salvage radiotherapy. This distinction is important because many men
would prefer to avoid prolonged hormonal therapy with its associated
side effects of hot flashes, sexual dysfunction, and changes in body fat
and muscle distribution. The answer to this controversy is unknown and
these decisions must be made on an individual basis between the patient
and his physician.
Place for Optimism
Relying on postoperative radiotherapy to deter the spread of cancer may
have to be revisited. But, with new and more effective detection
techniques, we might not have to worry about postoperative radiotherapy.
Men will be treated soon enough so that a recurrence of the cancer is
unlikely. And that world is the best of all possible worlds.

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
ronju99 - 15 Mar 2005 14:13 GMT
Don't panic!
The article that Curtis is refering to is only refering to men who have
had recurrence and not all treated men.
Ron S
ronju99 - 15 Mar 2005 14:43 GMT
Once again we have another bad misleading study to influence the
uninformed. The study refers to 1700+ men who had seed OVER a twelve year
period and came to a conclusion based upon all the data they found.
However probably only a handful of the men actually survived for twelve
years. The rest of the men haven't been around for twelve years so why
would you include them in the study. Tell us how many men had seeds
implanted  in 1992. Not the ones that haven't reached twelve years yet. I
believe there results would naturally inflate the results.
Ron S
ronju99 - 15 Mar 2005 15:11 GMT
Also, contrary to others opinion, Theraseed are accurately placed in the
prostate with the guidance of 3D-conformal raditation within the tumor
therebye saving the surrounding healthy tissue.
When one researches the companies profile, you will see that all there
income is derived from the sell of the seeds and sells have been down.
Ron S
Beverley - 15 Mar 2005 04:46 GMT
Radiation to the prostate to treat prostate cancer does NOT cause prostate
cancer. It might cause radiation induced cancer someday. If someone has just
external beam radiation then it is possible for the prostate to "heal itself
" and possibly whatever caused the cancer in the first place could cause a
reoccurrence of PC. But after brachytherapy there should not be any
prostate cells left. What was once the prostate is now just a tiny nub of
scar tissue wrapped around a bunch of seeds.

Nobody ever knows if they are cancer free after treatment. Just one little
escaped cell is all it takes for the cancer to continue. And when does 1
cell become 15 cells and those cells become 300 cells and those 300 become
50,000? I have no clue as it depends on many factors including the type of
cancer cell. But it doesn't matter if you've had a RP or brachytherapy, the
outcome is going to be the same. The only way to stop the cancer is to catch
it all while it is still in the prostate beyond that it gets dicey. And most
of the time there is no way to tell if they missed something during
RT/brachy/RP until much later down the road. That's why you guys have to
continue to have PSA tests for as long as you live!
Bev

> hi bob - i posted an article about the pd-103 a couple of weeks ago and
> it was using the same company's report.
[quoted text clipped - 37 lines]
> invariably fatal. Prostate cancer is only sometimes so."
> http://community.webtv.net/PALMER_ENT/doc
ron - 15 Mar 2005 16:33 GMT
> Radiation to the prostate to treat prostate cancer does NOT cause prostate
> cancer. It might cause radiation induced cancer someday. If someone has just
[quoted text clipped - 3 lines]
> prostate cells left. What was once the prostate is now just a tiny nub of
> scar tissue wrapped around a bunch of seeds.

Bev...Mustn't there be prostate cells remaining, after all, a non-zero
PSA can be measured after RT.  That being the case, why can't the RT
treatment cause another prostate cancer to emerge somewhere down the
road.  I hadn't really thought about this possibility until Curtis
mentioned it up above, but since RT can cause secondary cancers in the
areas surrounding the prostate, why couldn't it cause a new prostate
cancer to appear in the remaining prostate cells at some later date.
It seems logical, although I've never seen it discussed before.
Perhaps it hasn't been mentioned in the literature because how could
you differentiate a secondary prostate cancer caused by the RT from a
recurrence due to cancerous tissue that wasn't killed by the RT?..Best
wishes and good health, Ron
ron - 15 Mar 2005 16:33 GMT
> Radiation to the prostate to treat prostate cancer does NOT cause prostate
> cancer. It might cause radiation induced cancer someday. If someone has just
[quoted text clipped - 3 lines]
> prostate cells left. What was once the prostate is now just a tiny nub of
> scar tissue wrapped around a bunch of seeds.

Bev...Mustn't there be prostate cells remaining, after all, a non-zero
PSA can be measured after RT.  That being the case, why can't the RT
treatment cause another prostate cancer to emerge somewhere down the
road.  I hadn't really thought about this possibility until Curtis
mentioned it up above, but since RT can cause secondary cancers in the
areas surrounding the prostate, why couldn't it cause a new prostate
cancer to appear in the remaining prostate cells at some later date.
It seems logical, although I've never seen it discussed before.
Perhaps it hasn't been mentioned in the literature because how could
you differentiate a secondary prostate cancer caused by the RT from a
recurrence due to cancerous tissue that wasn't killed by the RT?..Best
wishes and good health, Ron
Beverley - 15 Mar 2005 23:10 GMT
I'm not a doctor or a pathologist so I don't know how they differentiate
between different cancer cells. But I do know they can biopsy something like
a liver and tell you that the cancerous liver is filled with prostate cancer
or breast cancer or lung cancer and NOT liver cancer. And apparently
radiation induced cancer has it's own "markers" (for lack of a better word).
For instance you can have 3 tumors in the colon and each one be a different
type of colon cancer yet all be large cell cancers. It's very interesting,
somehow they can tell all this apart.

Any remaining prostate cells can become cancerous no matter which treatment
was given. I guess if they could solve the mystery as to what caused the
prostate to become cancerous in the first place they might be able to stop
it from happening again. Or does the return of PC happen only because there
are renegade prostate cells surviving outside the prostate at the time of
treatment. If we can figure out the answer we'd be rich! And I know a few
men who would be happy campers.
Bev

> > Radiation to the prostate to treat prostate cancer does NOT cause
> prostate
[quoted text clipped - 21 lines]
> recurrence due to cancerous tissue that wasn't killed by the RT?..Best
> wishes and good health, Ron
 
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