New Minimally invasive treatment for prostate cancer

HIFU- A Non-Invasive Way to Treat Prostate Cancer

High Intensity Focused Ultrasound, or HIFU, is a therapy that destroys
tissue
with rapid heat elevation, which essentially “cooks” the tissue.
Ultrasound
energy, or sound waves, is focused at a specific location and at that
“focal
point,” the temperature raises to
almost 90 degrees Celsius in a
matter of seconds. Any tissue at
the “focal point” is destroyed;
however, any tissue outside of
the focal point remains
unharmed.
HIFU has produced oncological
results that are broadly
comparable to standard therapies
and is the only non invasive
prostate cancer therapy that does not use ionizing radiation. The risk
of urinary incontinence and impotence is much less than with surgery
or radiation.

For more information contact
Dr. Michael Wolff
Burlington Urological Associates
841 Heather Road
Burlington, NC 27215
(336) 227-2761
michael.wolff@urologyNC.com
www.InternationalHIFU.com

On Jun 18, 9:16 am, prostatedoc <michaelrwo...@gmail.com> wrote:
> HIFU- A Non-Invasive Way to Treat Prostate Cancer
>
> High Intensity Focused Ultrasound, or HIFU, is a therapy that destroys
> tissue
> with rapid heat elevation, which essentially “cooks” the tissue.
> Ultrasound
> energy, or sound waves, is focused at a specific location and at that
> “focal
> point,” the temperature raises to
> almost 90 degrees Celsius in a
> matter of seconds. Any tissue at
> the “focal point” is destroyed;
> however, any tissue outside of
> the focal point remains
> unharmed.
> HIFU has produced oncological
> results that are broadly
> comparable to standard therapies
> and is the only non invasive
> prostate cancer therapy that does not use ionizing radiation. The risk
> of urinary incontinence and impotence is much less than with surgery
> or radiation.
>
> For more information contact
> Dr. Michael Wolff
> Burlington Urological Associates
> 841 Heather Road
> Burlington, NC 27215
> (336) 227-2761
> michael.wo...@urologyNC.comwww.InternationalHIFU.c om

Dr. Wolff,

I assume you are a HIFU practitioner. I'd like to ask you some
questions about it which I hope you will be kind enough to answer
here for the benefit of the whole group.

1. Is there a hospital stay involved, how long?

2. What sort of anaesthetics are required? Is the patient put to
sleep?

3. Is there pain afterwards? How long is the recovery time?
Will the patient have to stay home for any length of time?

4. What kind of PSA profile should a patient expect after a
successful procedure? How low does the PSA go, how long does
it take to get there, can there be ups and downs like the PSA
"bounce" after brachytherapy?

5. If you suspect that the tumor has begun to invade surrounding
tissues (e.g., because of a high PSA or Gleason, or a large
number of positive biopsy samples), do you treat the
surrounding area? Do you use HIFU or radiation for that?

6. Do you ever use adjuvant or neo-adjuvant hormone deprivation
therapy?

7. If the procedure appears not to have worked, but there is no
evidence yet of metastatic disease, what would be the next
step - more HIFU? Radiation? Surgery? ADT?

8. Do you know the status of HIFU with respect to U.S. FDA
approval? Do insurers pay for it yet? How do costs compare
to other treatments?

9. Are there specific clinical trial reports we should look at to
evaluate the effectiveness of HIFU and its side effects
relative to other treatments?

10. What is the availability of the procedure in the U.S.

Thank you very much.

Alan

Alan Meyer wrote:

>
> 8. Do you know the status of HIFU with respect to U.S. FDA
> approval? Do insurers pay for it yet? How do costs compare
> to other treatments?

If you look at the website that dr. Wolff refers to, you'll see this
message:

"The Sonablate® 500 is not approved for use in the U.S. The Sonablate®
500 remains investigational in the U.S. and is being studied for the
treatment of prostate cancer in clinical trials in the U.S. FDA has made
no decision as to the safety or efficacy of the Sonablate®500 for the
treatment of prostate cancer."
>

>
> 10. What is the availability of the procedure in the U.S.

You'll have to go Mexico or Canada. (Don't forget to drop by Heather and
give her a kiss.) Again, see the sites. Based on the testimonials it
takes less than a day.
>
> Thank you very much.
>
> Alan
>

On Jun 18, 7:16*am, prostatedoc <michaelrwo...@gmail.com>
wrote...snip...
> HIFU- A Non-Invasive Way to Treat Prostate Cancer
> HIFU has produced oncological results that are broadly comparable to standard therapies and is the only non
> invasive prostate cancer therapy that does not use ionizing radiation.

Doc...What does "broadly comparable" mean? My take has been that
while HIFU appears to have a place in treating recurrent disease, men
with co-morbidities and perhaps in men with high-risk disease; its use
in the treatment of low-risk, localized disease (the kind of disease
the majority of men are diagnosed with these days) is questionable. A
number of studies have shown BNed rates much lower for HIFU than for
surgery or RT. Here is yet another abstract that makes this point,
this one is from the May 2008 AUA meeting and Gelet is a HIFU
artist...ron

1158] ONCOLOGICAL BENEFITS OF A SECOND HIFU SESSION WHEN RESIDUAL
PROSTATE CANCER IS FOUND FOLLOWING THE FIRST HIFU TREATMENT

Francois-Joseph Murat*, Laura Poissonnier, Jean-Yves Chapelon, Marc
Colombel, Olivier Rouviere, Albert Gelet, Lyon, France

INTRODUCTION AND OBJECTIVE: Diagnosis of residual localized prostate
cancer (PCa) was not uncommon when prototype HIFU devices were used
for treatment. However, the repeatability of HIFU is one of the major
advantages of this minimally invasive treatment. We evaluated the
oncological efficacy of a second HIFU session for residual localized
PCa.
METHODS: Patient with biopsy proven residual localized PCa following
HIFU were offered a second HIFU session. Follow-up included serial PSA
measurements every 3 months, systematic follow-up biopsies 3 months
post-HIFU and also in the case of rising PSA. The Phoenix criteria
(nadir+2 OR positive biopsy OR initiation of further treatment) was
used to define the disease free survival rate (DFSR). Patients were
stratified according to risk group.
RESULTS: 518 patients underwent HIFU with a prototype device between
01/2000 and 05/2005. Included in this analysis are the 227 patients
(mean age 69.9 years) who underwent a second HIFU treatment. The
positive biopsy that indicated second HIFU was found during systematic
control (58%) or following PSA rise (42%) with a mean of 16.6 months
between 2 sessions. The pre-HIFU retreatment PSA and prostate volume
were 2.1 +/-2.2 and 9.5 +/-5 cc, respectively. An increase in Gleason
sum was observed in 17% of patients. With 4% having a Gleason sum
equal or superior to 8. The location of recurrence was equally
distributed in the prostate (37% apex, 38% mid, 25% base). The second
HIFU procedure was well tolerated. Mean post-2nd HIFU follow-up was 25
months. Mean post-2nd HIFU PSA nadir and prostate volume was 0.66 +/-
1.44 ng/ml and 7 +/-6.7 cc, respectively. Control biopsies were
negative in 77% of the 182 patients who accepted systematic control.
Actuarial 5-year specific survival was 99%. Actuarial 4-year DFSR was
53% with significant difference between low and intermediate risk
patients, 67% and 46%, respectively (p=0.05).
CONCLUSIONS: Approximately half of the patients with residual LPca
after a first HIFU session will be disease-free at 4 years following a
second HIFU procedure. Unlike radiation, HIFU offers the opportunity
to be repeated.

Monday, May 19, 2008 3:30 PM

Moderated Poster Session 41: Prostate Cancer: Localized (III) (3:30
PM-5:30 PM)

if you are considering HIFU (I had it done and am a big supporter) -
understand that there are two different approaches to it The Sonobalde
500 and Ablatherm. Evaluate them both as they take different
approaches, approach mitigation of side effects differently and you
will likely find one more appealing than the other. You can find more
information on the Ablatherm approach at www.hifu.ca

HIFU is approved in Canada and I understand that many US patients come
to Toronto to have it done. Both Sonoblade and Ablatherm are
available in Toronto.

On Wed, 18 Jun 2008 06:16:20 -0700 (PDT), prostatedoc
<michaelrwolff@gmail.com> wrote:

>HIFU- A Non-Invasive Way to Treat Prostate Cancer
>
>High Intensity Focused Ultrasound, or HIFU, is a therapy that destroys
>tissue
>with rapid heat elevation, which essentially “cooks” the tissue.
>Ultrasound
>energy, or sound waves, is focused at a specific location and at that
>“focal
>point,” the temperature raises to
>almost 90 degrees Celsius in a
>matter of seconds. Any tissue at
>the “focal point” is destroyed;
>however, any tissue outside of
>the focal point remains
>unharmed.
>HIFU has produced oncological
>results that are broadly
>comparable to standard therapies
>and is the only non invasive
>prostate cancer therapy that does not use ionizing radiation. The risk
>of urinary incontinence and impotence is much less than with surgery
>or radiation.
>
>For more information contact
>Dr. Michael Wolff
>Burlington Urological Associates
>841 Heather Road
>Burlington, NC 27215
>(336) 227-2761
>michael.wolff@urologyNC.com
>www.InternationalHIFU.com

On Wed, 18 Jun 2008 09:35:12 -0700 (PDT), Alan Meyer
<ameyer2@yahoo.com> wrote:

>On Jun 18, 9:16 am, prostatedoc <michaelrwo...@gmail.com> wrote:
>> HIFU- A Non-Invasive Way to Treat Prostate Cancer
>>
>> High Intensity Focused Ultrasound, or HIFU, is a therapy that destroys
>> tissue
>> with rapid heat elevation, which essentially “cooks” the tissue.
>> Ultrasound
>> energy, or sound waves, is focused at a specific location and at that
>> “focal
>> point,” the temperature raises to
>> almost 90 degrees Celsius in a
>> matter of seconds. Any tissue at
>> the “focal point” is destroyed;
>> however, any tissue outside of
>> the focal point remains
>> unharmed.
>> HIFU has produced oncological
>> results that are broadly
>> comparable to standard therapies
>> and is the only non invasive
>> prostate cancer therapy that does not use ionizing radiation. The risk
>> of urinary incontinence and impotence is much less than with surgery
>> or radiation.
>>
>> For more information contact
>> Dr. Michael Wolff
>> Burlington Urological Associates
>> 841 Heather Road
>> Burlington, NC 27215
>> (336) 227-2761
>> michael.wo...@urologyNC.comwww.InternationalHIFU.c om
>
>Dr. Wolff,
>
>I assume you are a HIFU practitioner. I'd like to ask you some
>questions about it which I hope you will be kind enough to answer
>here for the benefit of the whole group.
>

I'm definitely no Doc - but I researched this a lot before deciding to
have it done. My "understanding" on your questions is given below.

>1. Is there a hospital stay involved, how long?

I was in for 6 hours, then walked back to my hotel. Was out at a pub
that evening for dinner
>
>2. What sort of anaesthetics are required? Is the patient put to
> sleep?

I had a spinal and a general via IV)
>
>3. Is there pain afterwards? How long is the recovery time?
> Will the patient have to stay home for any length of time?

I was ready to go back to work the next day but took 3 days off -
primarily because there is an emotiional relaxation after you are done
- plus getting use to the catheter takes some time
>
>4. What kind of PSA profile should a patient expect after a
> successful procedure? How low does the PSA go, how long does
> it take to get there, can there be ups and downs like the PSA
> "bounce" after brachytherapy?

The studies I have read showed the same (or slightly better) PSA
results as RP
>
>5. If you suspect that the tumor has begun to invade surrounding
> tissues (e.g., because of a high PSA or Gleason, or a large
> number of positive biopsy samples), do you treat the
> surrounding area? Do you use HIFU or radiation for that?

I 'think' my Doc said he could go into the fatty tissue around the
prostate if necessary - but I'm not 100% sure on this one
>
>6. Do you ever use adjuvant or neo-adjuvant hormone deprivation
> therapy?
>
>7. If the procedure appears not to have worked, but there is no
> evidence yet of metastatic disease, what would be the next
> step - more HIFU? Radiation? Surgery? ADT?

I understand about 10% of patients need additional treatment. More
HIFU is generally an option - but of course every case is different. A
nice thing about HIFU is it usually doesn't preclude any other
treatment as a second treatment (should a 2nd treatment be necessary)
>
>8. Do you know the status of HIFU with respect to U.S. FDA
> approval? Do insurers pay for it yet? How do costs compare
> to other treatments?

Not FDA approved, I understand clinical trials underway. been used in
europe for about 15 or so years (I think). Been approved and in use
in Canada for about 5 years
>
>9. Are there specific clinical trial reports we should look at to
> evaluate the effectiveness of HIFU and its side effects
> relative to other treatments?

Follow the links from www.hifu.ca to a good number of reports (this is
a different HIFU technology though)
>
>10. What is the availability of the procedure in the U.S.

I understand that US patients often go to Toronto to have this done.
>
>Thank you very much.
>
> Alan

On Wed, 18 Jun 2008 21:21:41 -0600,
kendotwiensatkgwhyphenconsultantsdotcom wrote:

snip

>>4. What kind of PSA profile should a patient expect after a
>> successful procedure? How low does the PSA go, how long does
>> it take to get there, can there be ups and downs like the PSA
>> "bounce" after brachytherapy?
>
>The studies I have read showed the same (or slightly better) PSA
>results as RP

With immediate post-RP PSA values for organ-confined disease at
<zero+noise>, there's no possibility of being 'slightly better'.

As to the longer term outlook, HIFU is too new for us to know.

Is the OP confusing RP and RT? (..ed; that's enough 2-letter
acronmyms)

On Thu, 19 Jun 2008 10:18:15 +0100, rosbif wrote:

>On Wed, 18 Jun 2008 21:21:41 -0600,
>kendotwiensatkgwhyphenconsultantsdotcom wrote:
>
>snip
>
>>>4. What kind of PSA profile should a patient expect after a
>>> successful procedure? How low does the PSA go, how long does
>>> it take to get there, can there be ups and downs like the PSA
>>> "bounce" after brachytherapy?
>>
>>The studies I have read showed the same (or slightly better) PSA
>>results as RP
>
>With immediate post-RP PSA values for organ-confined disease at
><zero+noise>, there's no possibility of being 'slightly better'.

I'm looking at the 3-5 year statistics in Canada (and some of the 7 -
10 year numbers from Europe).

Depending upon the studies, the 5 - 10 year post RP recurrence values
are often closer to 90% I thought. HIFU certainly doesn't have the
sizable statistical basis of RP, but it has been around a lot longer
than many people realize. I'm told that it is because HIFU can go
beyond the margin of the prostate that it achieves slightly better
numbers than RP.

>
>As to the longer term outlook, HIFU is too new for us to know.
>
>Is the OP confusing RP and RT? (..ed; that's enough 2-letter
>acronmyms)

On Thu, 19 Jun 2008 22:19:52 -0600,
kendotwiensatkgwhyphenconsultantsdotcom wrote:

>On Thu, 19 Jun 2008 10:18:15 +0100, rosbif wrote:
>
>>On Wed, 18 Jun 2008 21:21:41 -0600,
>>kendotwiensatkgwhyphenconsultantsdotcom wrote:
>>
>>snip
>>
>>>>4. What kind of PSA profile should a patient expect after a
>>>> successful procedure? How low does the PSA go, how long does
>>>> it take to get there, can there be ups and downs like the PSA
>>>> "bounce" after brachytherapy?
>>>
>>>The studies I have read showed the same (or slightly better) PSA
>>>results as RP
>>
>>With immediate post-RP PSA values for organ-confined disease at
>><zero+noise>, there's no possibility of being 'slightly better'.
>
>I'm looking at the 3-5 year statistics in Canada (and some of the 7 -
>10 year numbers from Europe).
>
>Depending upon the studies, the 5 - 10 year post RP recurrence values
>are often closer to 90% I thought.

True, but it was the unimprovable starting point of zero - or
effectively zero - that I meant to underline, sorry if I wasn't clear.

For sure, at 10 years things start to get ragged but I honestly don't
believe there is as yet any useful comparison between the durability
of RP and HIFU. Do you happen to know the ratio between the numbers
of the procedures carried out? Does the range of patient profiles
make the comparison meaningful? Does HIFU not lean towards patients
with earlier stage disease? Links to results would be of interest
here if you have any.


>HIFU certainly doesn't have the
>sizable statistical basis of RP, but it has been around a lot longer
>than many people realize. I'm told that it is because HIFU can go
>beyond the margin of the prostate that it achieves slightly better
>numbers than RP.

This could turn out to be the case, but we'll have to wait for a
rigorous overview and I believe we're a long way off at the moment.

On Jun 19, 10:19*pm, kendotwiensatkgwhyphenconsultantsdotcom
wrote...snip...

> Depending upon the studies, the 5 - 10 year post RP recurrence values
> are often closer *to 90% I thought. *

Do you mean non-recurrence values?

> *I'm told that it is because HIFU can go
> beyond the margin of the prostate that it achieves slightly better
> numbers than RP.

The "slightly better numbers" that you refer to, is this PSA or
recurrence numbers that you are referring to? In either case, it
would run counter to what I've read. Could you provide a reference?
Thanks...ron

kendotwiensatkgwhyphenconsultantsdotcom wrote:

> ...
> I'm definitely no Doc - but I researched this a lot before deciding to
> have it done. My "understanding" on your questions is given below.
> ...

That was a very useful set of replies.

Thanks.

Alan

ron wrote:
....
> RESULTS: 518 patients underwent HIFU with a prototype device between
> 01/2000 and 05/2005. Included in this analysis are the 227 patients
> (mean age 69.9 years) who underwent a second HIFU treatment.
....

Sounds like the success rate for the prototype device wasn't too
high. 227 / 518 = 44% required additional treatment. Within the
study period, only 56% did not (and maybe some of them will later
on.)

But then it was a "prototype" device and experience by the docs
and the manufacturer was probably more limited than with surgery
or radiation.

> CONCLUSIONS: Approximately half of the patients with residual LPca
> after a first HIFU session will be disease-free at 4 years following a
> second HIFU procedure. Unlike radiation, HIFU offers the opportunity
> to be repeated.

That looks better. 56% + (.5 * 44%) = 76%.

Two procedures doesn't sound outrageous - assuming that they are
not too onerous. One wonders if a third procedure would be
beneficial to any of the remaining 23-24%. At some point we must
run into a residual wall of men who have systemic disease before
treatment even starts.

There's so much we don't know about any of this. For example, if
we broke down the results, would we find that there were multiple
practitioners and one had particularly good results and another
had particularly poor results - something that is common with
other kinds of treatment?

Might we find that men treated near the beginning of the study
had worse outcomes than men treated near the end - when the docs
had more experience?

If we broke down the patients by Gleason grade, PSA, or other
characteristics, would we find that the pattern of success vs.
failure is different from surgery or radiation? It seems that
both surgery and radiation have high success rates on G6 cancers.
If HIFU turned out to be worse for those, but better for, say, G8
or G9, that would be great news.

There's still lots to learn.

Alan