15 years of experience with HIFU using Ablatherm technology

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.

2 Responses

  1. Please , we need information regarding HIFU application after brachytherapy.

    Many thanks

  2. Dear Renato:

    In theory it would be possible to use HIFU as second-line treatment after brachytherapy to treat men with clinically localized but biochemically recurrent prostate cancer. However, I am not aware of data even from a large case series of patients of this type.

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