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Thread: horrifying trial results for 2nd generation Ablatherm

  1. #1

    horrifying trial results for 2nd generation Ablatherm

    A trial of 2nd generation Ablatherm, looking at patients treated in Lyon, France went so badly in terms of treatment failure and side effects that it was aborted.


    "Using the Phoenix definition of biochemical failure, HIFU treatment failed in 13 patients in the primary group (46%) and five in the salvage group. Using the FDA trial endpoint, HIFU failed in 21 patients in the primary group (75%) and eight in the salvage group. One man died from metastatic prostate cancer 18 months after salvage HIFU. There were two urethral strictures in the primary (7%) and one in the salvage treatment group. There were two prostato-rectal fistulae in the salvage HIFU group. CONCLUSIONS HIFU is proposed to be a minimally invasive low-morbidity ablative treatment for localized prostate cancer, and with good efficacy. The present limited series is unable to support these claims. There were significant rates of complications and oncological failure in both the primary and salvage setting. As a result we have suspended our programme pending further evidence of its safety and efficacy."

    Dx Feb 2006, PSA 9 @age 43
    RRP Apr 2006 - Gleason 3+4, T2c, NXMX, pos margins
    PSA 5/06 <0.1, 8/06 0.2, 12/06 0.6, 1/07 0.7.
    Salvage radiation (IMRT) total dose 70.2 Gy, Jan-Mar [email protected] age 44
    PSA 6/07 0.1, 9/07 (and thereafter) <0.1

  2. #2


    The trial was in the UK, at Guy's & St. Thomas' NHS Foundation Hospital.

    Lyon, France is where EDAP, manufacturer of Ablatherm, is located.

    Dx Feb 2006, PSA 9 @age 43
    RRP Apr 2006 - Gleason 3+4, T2c, NXMX, pos margins
    PSA 5/06 <0.1, 8/06 0.2, 12/06 0.6, 1/07 0.7.
    Salvage radiation (IMRT) total dose 70.2 Gy, Jan-Mar [email protected] age 44
    PSA 6/07 0.1, 9/07 (and thereafter) <0.1

  3. #3
    My goodness, Replicant, that is terrible!!!
    Long-term cancer survivor
    1992 Astrocytoma grade 2, left motor strip
    2005 Recurrence this time said to be an Oligodendroglioma grade 3, same location.
    My Story Part 1: http://cancerforums.net/viewtopic.php?t=2528
    My Story Part 2: http://cancerforums.net/viewtopic.php?p=7350
    My Story Part 3: http://cancerforums.net/viewtopic.php?t=8029

  4. #4

    That is a terribly discouraging report.

    One other point just hit me after reading the posts by DavesWife and Mkane09 (I guess I am dense).

    They base the viability of the HIFU on a Gleason of less than 7 with confined disease. The problem is that how often do we read that men who go into surgery thinking they have stats that would qualify them for HIFU only to find out that their Gleason score and/or the extent of the disease is upgraded after a pathology report If it was actually possible to tell the extent of disease prior to surgery, then pathology exams would not even be necessary. There would be no need to sample lymph nodes etc.

    It raises the question of how many people that may opt for HIFU and some other treatments really have PCa that would disqualify them from that procedure if it were known.
    History: age 53 It took 3 biopsies (34 cores) to find 2 cores 4+4 Gleason 8
    Lap RP at MSKCC Apr 2004, age 54 All neg margins, nodes & structures. (T2a).
    Post RP PSA: <.1 until Feb, 08 (46 mos) PSA 0.1 - I then got sensitive tests -> 2008: Feb 0.06,
    May-08 0.09 - Jun-08 0.10, - Aug-08 0.10, - Nov-08 0.15
    SRT Dec-2008 ---Post SRT PSA 2009, Feb-09 0.10, May-09 0.09, Aug-09 0.06, Dec-09 .04, - 2010 Mar-09 0.04, 2011 .02, 2012 .02,
    STARTED UP Feb 2014-0.06, Jul-2015 0.10, Oct-2015 0.10, Feb-2016 0.15, Jun-2016 0.17, Dec-2016 0.25, Jan-2019 0.74, Jun -2019 0.72
    Aug 2018 Auximin scan - nothing
    Had an inflatable penile implant 2018 for ED. Best decision ever https://www.peyroniesforum.net/index...oard,56.0.html

  5. #5
    Here's a ten year study that has a completely different outcome...

    "Dr. Stefan Thuroff presented a discussion on efficacy, results and safety covering 10 years of experience based on treatments at University Hospital of Munich, Harlaching, Germany. The 10-year experience with Ablatherm-HIFU in Europe clearly demonstrates the clinical, technical and safety strength compared to other treatments. Dr. Thuroff's presentation reiterated negative biopsy rates from 79.4 percent in locally advanced prostate cancer to 93.7 percent in localized low to medium risk prostate cancer cases. "

    read the entire article at:

    Here's another pubmed article:

    Short-term outcome after high-intensity focused ultrasound in the treatment of patients with HIGH- RISK prostate cancer........
    CONCLUSIONS: HIFU is a modern, minimally invasive therapy for prostate cancer, often used in selected patients with localized disease. The present results show that HIFU was also feasible in patients with high-risk prostate cancer. The low complication rates and favourable functional outcome support the planning of further larger studies in such patients. The oncological efficacy of HIFU should be assessed in further studies with a longer follow-up.

    http://www.ncbi.nlm.nih.gov/pubmed/17125477?ordinalpos=1&itool=EntrezSystem2.PEntrez. Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.P ubmed_Discovery_RA&linkpos=3&log$=relatedarticles& logdbfrom=pubmed

    MY conclusion: Your choice of doctor and which machine (Albatherm or Sonablate) sure is important no matter what choice you make.

    My HIFU treatment was picture perfect.

  6. #6

    statement by EDAP

    EDAP, manufacturer of Ablatherm, says on its webpage HIFU Planet:

    "Ablatherm HIFU is a therapy that now has 10 years of follow-up. Because it has less follow-up than traditional techniques, it is recommended for older patients who have a life expectancy of 10 to 15 years. Nevertheless, each patient is free to choose their preferred type of treatment. In some instances, younger patients have chosen Ablatherm HIFU because they do not want to undergo complex surgical procedures or lengthy radiation treatments." http://www.hifu-planet.co.uk/2_Engli...ications-.html

    I was one of the younger ones, with a life expectancy of more than 40 years, and I wasn't all that fearful of surgery.

    Dx Feb 2006, PSA 9 @age 43
    RRP Apr 2006 - Gleason 3+4, T2c, NXMX, pos margins
    PSA 5/06 <0.1, 8/06 0.2, 12/06 0.6, 1/07 0.7.
    Salvage radiation (IMRT) total dose 70.2 Gy, Jan-Mar [email protected] age 44
    PSA 6/07 0.1, 9/07 (and thereafter) <0.1


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