These long term outcomes represent HIFU emerging from investigational status to become a standard primary treatment option.

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These long term outcomes represent HIFU emerging from investigational status to become a standard primary treatment option.

by d2322 on Tue May 10, 2011 03:49 AM

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·    I Found this Abstract on the AUA website

     INTRODUCTION AND OBJECTIVES:The utilization of HIFU as a primary therapy for prostate cancer continues to increase. The objective of this study is to report 10 year biochemical and biopsy outcomes of patients who have undergone HIFU and were followed with the @-Registry. This is the largest HIFU series ever reported. 

METHODS:
The @-Registry is a secure on-line database consisting of case report forms, which collect relevant data from patients undergoing prostate HIFU. Those patients with stage T1-3 prostate cancer who had undergone HIFU with Ablatherm (EDAP-TMS, Lyon, France) and had at least one PSA follow-up recorded following achievement of a nadir were included in the analysis. Patients were stratified according to D?Amico?s 2003 risk groups. Kaplan-Meier analysis was performed to determine biochemical survival with failure defined according to the 2006 Phoenix definition (nadir+2). Biopsy data was also analyzed as was post treatment morbidity.

RESULTS:
A total of 2552 consecutive patients met the inclusion criteria. The average age was 70.1 ± 6.5 years. Pre treatment PSA was 10.2 ± 12.6 ng/ml, the median Gleason sum was 6 and 30.6%, 39.4% and 30.0% of patients were in the low, moderate and high risk group, respectively. Patients were followed for 39.6 ± 31.2 (range: 3 to 193) months. The median PSA nadir was 0.11 ng/ml which was reached 12.9 ± 11.1 weeks after HIFU. Actuarial survivals at 5 and 10 years and biopsy data are reported in the table. Grade I, II and III incontinence was observed in 12.4%, 6.4% and 1.8% of the population, respectively. The stenosis rate was 18.5% and the retention rate was 11.0%. Potency data was inconsistent and is not presented herein. 

CONCLUSIONS:
HIFU provides good biochemical control through 10 years of follow-up with a mild morbidity profile. Negative biopsy rates are high across all risk groups. These long term outcomes represent HIFU emerging from investigational status to become a standard primary treatment option. 

1004
Roman Ganzer
Antonell Paulesu
Viktor Berge
Andreas Blana
Stephen Brown
Christian Chaussy
Sebastien Crouzet
John F. Ward
Stephan Thueroff
Cary N. Robertson
Regensburg, Germany

RE: These long term outcomes represent HIFU emerging from investigational status to become a standard primary treatment option.

by alady on Tue May 10, 2011 06:04 PM

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Cancer InfoLink posted this report of the study:


A media release issued by EDAP TMS SA – the developer and distributor of the Ablatherm® technology used in high-intensity focused ultrasound (HIFU) treatment of men with prostate cancer – states that a review of 15 years experience with Ablatherm technology will be published in the June issue  of Current Urology Reports.

The article (“Robotic high-intensity focused ultrasound for prostate cancer: what have we learned in 15 years of clinical use?“) is written by two recognized pioneers in the clinical use of HIFU: Professor Christian Chaussy and Dr. Stefan Thüroff, both of whom practice in Germany and have been heavily involved in the clinical application of HIFU using the Ablatherm system for the treatment of prostate cancer. According to this paper, some 30,000 HIFU procedures have been performed (mainly in Europe) over the past 10 years. The article has actually been available on line since March 23, 2011, but the abstract carries little really helpful information. The comments below reflect a careful reading of the full text of the paper (kindly provided to The “New” Prostate Cancer InfoLink by Professor Chaussy).

The review is based on the concept that HIFU, as carried out using Ablatherm technology, and largely in Europe, is “a nonexperimental therapy under long-term investigation for primary treatment of local[ized] prostate cancer as well as salvage therapy after radiation failure.” However, the authors are careful to note that HIFU also “appears to have a high potential” to treat less invasive forms of localized disease, as adjuvant therapy in the treatment of more advanced disease, and for debulking of tumor in men with non-metastatic, hormone-refractory disease. In particular, they state that, “The versatility of HIFU appears to be unique in the treatment of the entire spectrum of prostate cancer.”

Chaussy and Thüroff carefully list out the studies that have been conducted in support of the clinical application of Ablatherm-based HIFU in several areas:

  • First-line treatment of localized prostate cancer, including
    • “Normal” and potentially multifocal localized prostate cancer (clinical stage T1c and T2) as treated with HIFU to the whole gland
    • “Incidental” prostate cancer (clinical stage T1a,b) found as a consequence of a transurethral radical prostatectomy (a TURP), also treated with HIFU to the whole gland
    • “Focal” prostate cancer (usually clinical stage T1c) restricted to a single identifiable localized focus of cancer (or possibly more than one focus within a restricted area of the prostate) that can be treated with HIFU targeted to a limited area of the prostate
  • Second-line (“salvage”) treatment of refractory or recurrent prostate cancer, after failure of primary therapies, including
    • External beam radiation therapy (EBRT)
    • Different types of brachytherapy (with or without EBRT)
    • Cryotherapy
    • Primary HIFU
    • Radical prostatectomy
  • First-line treatment of locally advanced prostate cancer (clinical stage T3/4 disease)
  • Second-line therapy of PSA progression in men initially treated with androgen deprivation therapy (ADT) and with a local, biopsy-proven tumor recurrence

They also specifically refer to data suggesting that HIFU might be able to induce an immune response that could lead to cancer cell death — although the only data on this topic to date appear to be based on research in breast cancer rather than prostate cancer. 

In addition, the review is careful to address the adverse effects of Ablatherm-based HIFU reported to date, particularly noting the relatively common documentation of erectile dysfunction, strictures and stenosis, post-operative retention of urine, and urinary tract infections. It has become common among specialists using the Ablatherm technology to use a combination of TURP and HIFU to minimize risks of some of these adverse effects. It does appear that men with cancer close to one or other (or both) of the neurovascular bundles are at higher risk for erectile dysfunction post-HIFU as a consequence of the impact of focused ultrasound radiation of the neurovascular bundles.

As The “New” Prostate Cancer InfoLink has observed on several prior occasions, HIFU (using either the Ablatherm or the Sonoblate systems) has been approved for clinical use in many (but not all) European nations. However, it is still considered to be an investigational technique in the USA and several other countries around the world. It is likely to be some time yet before there are good data allowing us to compare the outcomes of similar patients treated with the two most common types of HIFU technology to each other, let alone to comparable patients treated with other very different methods. The potential of HIFU in certain types of patients appears considerable. Whether HIFU has the ability to achieve that potential is a very different question — especially in the USA, where it will need to prove that potential in randomized clinical trials if it is to gain approval for widespread clinical use from the U. S. Food & Drug Administration.

 

p.s.

I hear that Ablatherm usually causes ED as it is robotic, so there isn't the care that the doctor can  give in treatment. Plus you always have a TURP prior to treatment as the focal length is shorter than the Sonablate, and a TURP can cause ED or incontinence.

  My husband had HIFU well over two years ago and all went great, and he is cancer free.  Plus we've sent in lots of friends and ALL report no side effects (ED for a few months), no pain, no cancer and very happy.

RE: These long term outcomes represent HIFU emerging from investigational status to become a standard primary treatment option.

by d2322 on Tue May 10, 2011 07:05 PM

Quote | Reply

On May 10, 2011 6:04 PM alady wrote:

Cancer InfoLink posted this report of the study:


A media release issued by EDAP TMS SA – the developer and distributor of the Ablatherm® technology used in high-intensity focused ultrasound (HIFU) treatment of men with prostate cancer – states that a review of 15 years experience with Ablatherm technology will be published in the June issue  of Current Urology Reports.

The article (“Robotic high-intensity focused ultrasound for prostate cancer: what have we learned in 15 years of clinical use?“) is written by two recognized pioneers in the clinical use of HIFU: Professor Christian Chaussy and Dr. Stefan Thüroff, both of whom practice in Germany and have been heavily involved in the clinical application of HIFU using the Ablatherm system for the treatment of prostate cancer. According to this paper, some 30,000 HIFU procedures have been performed (mainly in Europe) over the past 10 years. The article has actually been available on line since March 23, 2011, but the abstract carries little really helpful information. The comments below reflect a careful reading of the full text of the paper (kindly provided to The “New” Prostate Cancer InfoLink by Professor Chaussy).

The review is based on the concept that HIFU, as carried out using Ablatherm technology, and largely in Europe, is “a nonexperimental therapy under long-term investigation for primary treatment of local[ized] prostate cancer as well as salvage therapy after radiation failure.” However, the authors are careful to note that HIFU also “appears to have a high potential” to treat less invasive forms of localized disease, as adjuvant therapy in the treatment of more advanced disease, and for debulking of tumor in men with non-metastatic, hormone-refractory disease. In particular, they state that, “The versatility of HIFU appears to be unique in the treatment of the entire spectrum of prostate cancer.”

Chaussy and Thüroff carefully list out the studies that have been conducted in support of the clinical application of Ablatherm-based HIFU in several areas:

  • First-line treatment of localized prostate cancer, including
    • “Normal” and potentially multifocal localized prostate cancer (clinical stage T1c and T2) as treated with HIFU to the whole gland
    • “Incidental” prostate cancer (clinical stage T1a,b) found as a consequence of a transurethral radical prostatectomy (a TURP), also treated with HIFU to the whole gland
    • “Focal” prostate cancer (usually clinical stage T1c) restricted to a single identifiable localized focus of cancer (or possibly more than one focus within a restricted area of the prostate) that can be treated with HIFU targeted to a limited area of the prostate
  • Second-line (“salvage”) treatment of refractory or recurrent prostate cancer, after failure of primary therapies, including
    • External beam radiation therapy (EBRT)
    • Different types of brachytherapy (with or without EBRT)
    • Cryotherapy
    • Primary HIFU
    • Radical prostatectomy
  • First-line treatment of locally advanced prostate cancer (clinical stage T3/4 disease)
  • Second-line therapy of PSA progression in men initially treated with androgen deprivation therapy (ADT) and with a local, biopsy-proven tumor recurrence

They also specifically refer to data suggesting that HIFU might be able to induce an immune response that could lead to cancer cell death — although the only data on this topic to date appear to be based on research in breast cancer rather than prostate cancer. 

In addition, the review is careful to address the adverse effects of Ablatherm-based HIFU reported to date, particularly noting the relatively common documentation of erectile dysfunction, strictures and stenosis, post-operative retention of urine, and urinary tract infections. It has become common among specialists using the Ablatherm technology to use a combination of TURP and HIFU to minimize risks of some of these adverse effects. It does appear that men with cancer close to one or other (or both) of the neurovascular bundles are at higher risk for erectile dysfunction post-HIFU as a consequence of the impact of focused ultrasound radiation of the neurovascular bundles.

As The “New” Prostate Cancer InfoLink has observed on several prior occasions, HIFU (using either the Ablatherm or the Sonoblate systems) has been approved for clinical use in many (but not all) European nations. However, it is still considered to be an investigational technique in the USA and several other countries around the world. It is likely to be some time yet before there are good data allowing us to compare the outcomes of similar patients treated with the two most common types of HIFU technology to each other, let alone to comparable patients treated with other very different methods. The potential of HIFU in certain types of patients appears considerable. Whether HIFU has the ability to achieve that potential is a very different question — especially in the USA, where it will need to prove that potential in randomized clinical trials if it is to gain approval for widespread clinical use from the U. S. Food & Drug Administration.

 

p.s.

I hear that Ablatherm usually causes ED as it is robotic, so there isn't the care that the doctor can  give in treatment. Plus you always have a TURP prior to treatment as the focal length is shorter than the Sonablate, and a TURP can cause ED or incontinence.

  My husband had HIFU well over two years ago and all went great, and he is cancer free.  Plus we've sent in lots of friends and ALL report no side effects (ED for a few months), no pain, no cancer and very happy.

????

Did you read what you posted??

You better do a little more homework on Sonobabble and work with the facts, not just hearsay.

RE: These long term outcomes represent HIFU emerging from investigational status to become a standard primary treatment option.

by alady on Mon May 16, 2011 08:37 PM

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I guess that you are referring to my statement that the TURP can cause ED or incontinence, while the article says they use the TURP to reduce these side effects.  That is not true, the Ablatherm uses a TURP because the focal length is short, it will only reach a gland that is 25cc or less, while the Sonablate will reach a gland that is 40cc or less.  My husband tried to enter the Ablatherm trial but he was turned away because his gland was larger than 25cc.  Any gland that has cancer is over 25cc, only in rare occasions will it be smaller.  Still they do a TURP, it's standard procedure with the Ablatherm.  And a TURP can be very painful (it's a roto rooter), and it can cause damage.  I know two guys who were treated using the Ablatherm and both have ED. 

RE: These long term outcomes represent HIFU emerging from investigational status to become a standard primary treatment option.

by Johnt on Tue May 17, 2011 02:14 AM

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A good unbiased article on the latest published data of HIFU.

http://www.prostate-cancer.org/pcricms/sites/default/files/P

 

RE: These long term outcomes represent HIFU emerging from investigational status to become a standard primary treatment option.

by skidan on Tue May 17, 2011 12:51 PM

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On May 17, 2011 2:14 AM Johnt wrote:

A good unbiased article on the latest published data of HIFU.

http://www.prostate-cancer.org/pcricms/sites/default/files/P DFs/Is14-1_p14-20.pdf"" target="_blank" rel="nofollow">http://www.prostate-cancer.org/pcricms/sites/default/files/P target="_blank" rel="nofollow">http://www.prostate-cancer.org/pcricms/sites/default/files/P

 

John,

    Thank you in educating me of the dismal long term outcome of this procedure. I use to think to think it was all about money, but in reality it is a very poor performing treatment compared to the others. I hope the FDA doesn't approve this procedure due to its bad results.

Thanks again, I would never suggest this treatment.

Dan

 

RE: These long term outcomes represent HIFU emerging from investigational status to become a standard primary treatment option.

by alady on Sat May 21, 2011 07:49 PM

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Dan,

I wonder what "treatment" that you would suggest?  By reading your posts it looks like none of them, you would only suggest people buy your book and follow your receipe.  You won't post what your receipe is.....so I doubt your heart is in a good place.

Johnt is devoted his life to pooh-poohing HIFU, I think he must be a surgeon's assistant.

ED was something my hubby had after HIFU, but only for a while.  That article Johnt posted says that a rising PSA means failure, but I don't think so, remember that there is still a gland, so some reading will always be there, only a big jump is of concern.  My husband feels that if you read any cancer forum you'll see that the cancer comes back, no matter what treatment, so treatment is just a set back, HIFU offers the best chance of a full life afterwards.

RE: These long term outcomes represent HIFU emerging from investigational status to become a standard primary treatment option.

by skidan on Mon May 23, 2011 12:10 PM

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On May 21, 2011 7:49 PM alady wrote:

Dan,

I wonder what "treatment" that you would suggest?  By reading your posts it looks like none of them, you would only suggest people buy your book and follow your receipe.  You won't post what your receipe is.....so I doubt your heart is in a good place.

Johnt is devoted his life to pooh-poohing HIFU, I think he must be a surgeon's assistant.

ED was something my hubby had after HIFU, but only for a while.  That article Johnt posted says that a rising PSA means failure, but I don't think so, remember that there is still a gland, so some reading will always be there, only a big jump is of concern.  My husband feels that if you read any cancer forum you'll see that the cancer comes back, no matter what treatment, so treatment is just a set back, HIFU offers the best chance of a full life afterwards.

Aladay,

    Normally I would not respond to someone like you. This is my final correspondence with you. I wish you well and I will answer all your questions, but no follow up.

1) Cose to 90 percent all of prostate cancer is not life threatening therefore I would suggest those with non aggressive cancer to watch their diet and take supplements. As far as the rest one size doesn't fit all. There are a number of treatments that are sccessful. However which ever treatment someone chooses with aggressive cancer I firmly beleive in order to improve their odds diet, supplements and life style changes are necessary.

2) Of all the traditional treatments none have such a poor outcome as HIFU. An 80% failure rate at 5 years is awful compared to surgery and radiation.

3) This one  you couldn't be more wrong about helping people. I have mentioned to many people what supplements would be of value to them. In additon I correspond with people all over the World how to tweak my system. Tell that to the Egyptian General how I reduced his tumor 90% with my approach, I spoke to him personally. Do you think I do this for the 2.00 a book I earn. I assure I have invested more time and money than I have recieved back. You should be ashamed of yourself in making such an accusation.

I hope your husband is one of the 20% that HIFU will be effective in 5 years.

Dan

RE: These long term outcomes represent HIFU emerging from investigational status to become a standard primary treatment option.

by beatingcancer on Mon May 23, 2011 06:02 PM

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Dan has been more than helpful to us. He has always been willing to take his time, free of charge, to answer questions day or night and encourage anyone who asks him. He is an excellent researcher and we  have found what he says to be true. He has blown the whistle when something isn't right, but I am grateful for that, it entices me to do my own homework and check it out.

 He knows what has worked well for him, as well as others, and has a heart to share it. Thanks Dan and may God continue to bless you. In Christ, Lynn and Mike

RE: These long term outcomes represent HIFU emerging from investigational status to become a standard primary treatment option.

by alady on Thu May 26, 2011 09:12 PM

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http://www.medpagetoday.com/MeetingCoverage/AUA/26644

You got your data screwed up, it's ....

Published: May 23, 2011
WASHINGTON -- More than 80% of men with localized prostate cancer had negative biopsies for as long as 10 years after treatment with high-intensity focused ultrasound (HIFU), data from a large clinical registry showed.

The negative biopsy rate ranged from 78.3% of patients with high-risk prostate cancer to 89.3% for men with low-risk disease.

"83% of the patients had negative biopsies at follow-up, including 89.3% of low-risk patients, 81.2% of intermediate-risk patients, and 78.3% of high-risk patients.

By Phoenix criteria..... Low-risk patients had failure-free rates of 84% at five years, 68% at 8 years, and 63% at 10 tears. Intermediate-risk patients had failure-free rates of 77%, 65%, and 54%. For high-risk patients, freedom from biochemical failure was 68% at five years, 58% at eight years, and 55% at 10 years.

I know of many men who are cancer free 5 years out, and yes, I know of a few who had HIFU twice....so what....it beats wearing diapers after surgery. 

If your heart was in the right place Dan, and the rest of you who know his receipe...you'd post it.   Personally, I don't believe him, or there would be lots of people here saying thanks.....and someone would want to share his "miracle".   Instead, click on his name and buy his book....

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