Oncologic outcomes of HIFU for localized prostate cancer in 800+ patients


An article still to be formally published in European Urology provides data on the outcomes of 803 patients with localized prostate cancer, all treated with high-intensity focused ultrasound (HIFU) between 1993 and 2007 at six centers in France.

Crouzet et al. analyzed data from a total of 1,457 cases to find the 803 patients who met study criteria for localized disease (clinical stage T1-2N0M0). Patients were categorized as low-, intermediate-, or high-risk according to the D’Amico criteria. All data were collected prospectively in a centralized database. Of the original 1,457 patients, 438 were excluded because they received neoadjuvant hormone therapy and another 216 patients were excluded because they had non-localized disease, or their PSA level was > 50 ng/ml, or clinical stage or Gleason data were missing, or they were followed for < 2 years.

The patients were all treated with one of three categories of Ablatherm device:

  • Prototype Ablatherm HIFU devices were used  between 1993 and 1999 — in a total of 80 patients.
  • After 2000 patients were treated with the first commercially available HIFU device (Ablatherm Maxis) — in a total of 446 patients.
  • After 2005 patients were treated with the second-generation commercial device (Ablatherm Integrated Imaging) — in a total of 277 patients.

In addition, after 2000, all patients received a transurethral resection of the prostate prior to HIFU.

The oncologic outcome data can be summarized as follows:

  • The average (mean) follow-up period was 42 ± 33 months.
  • Patients received one, two, or three HIFU sessions in total.
    • 521 patients (64.9 percent) received just one session.
    • 255 patients ( 31.7 percent) received two sessions.
    • 27 patients (3.4 percent) received three sessions.
    • For patients treated with the second-generation equipment after 2005, 85.2 percent (236/277 patients) required only one session of HIFU treatment, and no patient required more than two sessions.
  • Nadir PSA levels were achieved in ≤ 6 months for all patients.
  • The median nadir PSA level was 0.25 ng/ml, with a mean level of 1.0 ± 2.8 ng/ml.
  • 182 patients who relapsed after HIFU also received salvage therapy with either external beam radiation therapy (EBRT) or androgen deprivation therapy (ADT).
  • The estimated overall survival was 89 percent at 8 years.
  • The estimated prostate cancer-specific survival was 99 percent at 8 years.
  • The estimated metastasis-free survival was 97 percent at 8 years.

The full text of this article (which is available on line at the link given above) provides an enormous amount of additional detail about the oncologic outcomes of these 803 patients. Unfortunately, it gives absolutely no information at all about the adverse effects of HIFU in this patient series. The paper merely refers the reader to an older paper in which a different and much smaller series of HIFU patients treated by a German research group is said to have a 49.8 percent incidence of impotence post-treatment, while misleadingly stating that, “The morbidity was not analyzed in this study as it has already been published.”

Taken at face value, this paper implies that HIFU is capable of offering excellent oncologic outcomes in localized prostate cancer patients at an average of about 4 years of actual follow-up. However,  it needs to be recognized that 182/803 patients (22.6 percent) clearly relapsed after HIFU, and more than 25 percent of the intermediate- and high-risk patients still had positive biopsies after HIFU treatment.

Last, but by no means least, The “New” Prostate Cancer InfoLink thinks it is regrettable that peer-reviewed journals are accepting papers like this today without any reference to the adverse events of treatment in a significant patient series. The adverse effects of treatment are at least as important as the oncologic outcomes — and arguably more important. If HIFU is ever to emerge as a significant first-line treatment option for patients with early-stage prostate cancer, we need to be able to see and assess the side effects from this type of large series. Until such data are available, it is not even reasonable to make any decisions about the value of the oncologic outcomes. And the same is true today for data from any other form of therapy. In an ideal world, adverse events data should always accompany the oncologic outcome data (as they did in the paper published by Ahmed et al. almost exactly a year ago from a series of 172 patients at a single center).

10 Responses

  1. Only one incidence of incontinence has ever been reported, and Dr. Emberton said that was because “the learning curve” for giving HIFU hadn’t been achieved.

    ED is reported to be 19% by the doctors in Japan, and as a HIFU patient I can atest that ED can be easily remedied by the daily use of 5 mg Cialis taken for several months post HIFU, after all is healed inside — then all is well!!

    Thank you very much for posting this data.

  2. Dear Ron:

    While I am delighted that Cialis allowed you to recover potency post-HIFU, an N of 1 can hardly be considered compelling evidence.

    :O)

  3. I couldn’t possibly agree more that including detailed information about side effects should be included in every such paper published, and I’d even go one step further and urge the medical industry to develop standards for evaluating and reporting on side effects.

    Too many patients have been blind-sided by too many side effects they weren’t warned about, and some/many of those are irreversible! Shame on any researcher or publisher who reports on effects without also reporting on side effects!

  4. “ED can be easily remedied by the daily use of 5 mg Cialis taken for several months post HIFU, after all is healed inside — then all is well!!”

    That is a pretty bold statement! Do you have any idea how many men have tried Cialis (and every other drug out there) without benefit?
    ED sometimes CAN NOT be easily remedied! Sometimes it cannot be remedied at all. Period!

  5. Mark:

    Did you have HIFU and now have ED?

    There is a published rate of 19% [in Japan]. I certainly have no idea if that 19% took Cialis or not. For me ~ it worked. I just wanted to share my outcome.

    When you look at what HIFU does to the gland, i.e., shrink it, then it makes sense that nerves can be hurt, traumatized. At least they aren’t cut. Surgery has a 50/50 chance of ED.

    There are other studies that included side effects … See, for example, this report.

    A nadir of 1 is just fine; it’s a sudden, sharp rise that isn’t good. The nadir has been coming down as newer machines have come available.

  6. THANKS, AND NOTING UNCONSCIONABLE HYPING OF HIFU

    Sitemaster,

    Thanks again so much for your wonderful work in highlighting these important studies. It sure helps to have you helping us navigate through the flood of publications.

    Your particular article led to quite a stir in one of the areas where I participate. It is not pleasant to communicate to HIFU pioneers (patients) that follow-up study results, such as the results in the French study, are turning south, but it is key information for those new patients who are considering HIFU.

    One of the HIFU advocates in that area where I participate argued, reasonably, that unfavorable results with the older Ablatherm system did not mean that results with the newer Sonablate system would also be unencouraging. However, a PubMed search showed that results for Sonablate too went south as only a handful of years of follow-up ticked by.

    This HIFU advocate then countered with the assertion that the “cure” rate for HIFU was 94%, providing the organization InternationalHIFU as the source. That “cure” rate was absolutely not believable, so one of us called the organization to check. Their representative indeed gave 94% as the “cure” rate for low-risk men, citing data from the Uchida team in Japan as the source. The organization also provides a number of publications of medical research about HIFU results, including work from the Uchida team.

    Well, yes: you can find a 94% biochemical disease-free (non-recurrence) rate (NOT called a “cure” rate by the Uchida team) for low-risk men in their paper “Five years [as a practice – not average follow-up, my comment] experience of transrectal high-intensity focused ultrasound using the Sonablate device in the treatment of localized prostate cancer,” Int J Urol, 2006 Mar, 13(3): 228-33. Its based on “biochemical disease-free survival rates at 3 years for patients with a pretreatment rate of less than 10 …”

    However, the Uchida team’s report of their 8-year results (as a HIFU practice – again, not average follow-up) reports a discouraging development. Their comparable biochemical disease-free survival rate for men with “low-risk” disease at 5 years was only 84%! While a PSA of <10 and localized in the first "5-year" report and "low-risk" and localized in the later "8-year" report are not completely comparable, they are close, and the plunge in the recurrence-free success rate from 94% to 84% is disturbing, especially with just two more years of follow-up.

    It is also deeply disturbing that InternationalHIFU is not advising potential patients about the convergence of these less favorable findings from several points around the globe. I find it outrageous that InternationalHIFU is still using outdated information from the Uchida series, despite the Uchida update published in November of last year. (Transrectal high-intensity focused ultrasound for the treatment of localized prostate cancer: eigh-year experience", Int J Urol, 2009 Nov; 16(11):881-6. I'm not so fond of their using the word "cure" with naive patients either. (Hey, I was naive once — didn't even know what a DRE was when I got that first and fateful PSA; so were we all!)

    Ron – it's encouraging to hear a number of accounts of good experiences with side effects from HIFU, like yours. I'm even thinking that HIFU does probably have a lower side effect profile, at least after the first round of HIFU, compared to some other approaches. However, accumulating reports from around the world are indicating substantial percentages of men with problems like impotence in 49.8% in one series (A. Biana et al, the 2006 German study), and in 24% in another (6 year Uchida results with an average follow-up of 20 months).

    Here's hoping that someone will find a way to make this technology work more effectively so that it can become a sound alternative to established approaches.

  7. From my research, which includes reading many of these reports, but also most significantly patients’ first-hand accounts of their experiences with different procedures, the HIFU procedure offers the least chance of adverse quality of life-changing side effects. I realize the procedure is experimental, however I have no incontinence issues and no ED issues, in fact I was able to have erections 3 days after the procedure and never required the use of the prescribed Cialis.

    There is no side effect of [penis length reduction] which is almost never discussed with RP. The new Sonoblate machine with the Doppler feedback provides the doctor with instant feedback of the ablation at the cellular level and is light-years ahead of the early machines. The bottom line is every doctor truly believes their method is the best. You can make arguments and find data for and against, as well as find fantastic and horrific outcomes for every procedure. The only way to make a proper informed decision is to read patients’ first-hand accounts of the outcomes of these procedures and their satisfaction with the results, then weigh the data and decide for yourself. Sitemaster as the steward of this site you should not be discounting Ron’s accounting of his experience, you know perfectly well he is more than an N of 1. That comment was not necessary .

  8. I am 70 years old. I received tomotherapy approximately 4.5 years ago. (I thought all was well until and within the last 8 months my PSA increased from 2.5 to 4.6 ng/ml). My doctor states he believes my cancer returned and has suggested that I have HIFU. I believe he is right but I am doing as much research as possible. If you are a patient, or are knowledgeable, and can provide responsible information, I would VERY much appreciate your response. Like everyone else, this is a nightmare. Also, I see the cost ranges ranges from approximately $15k to $30k. Insurance will not pay for this. I have been referred to Dr. Sconti of NYU who practices in Mexico. Any comments or referrals will be VERY much appreciated. Time is obviously critical. Thank you in advance.

  9. Dear Kent:

    HIFU is currently being tested as a form of treatment for men with recurrent prostate cancer following radiation therapy. You can find out about this clinical trial if you click here. To be eligible you would have to be able to demonstrate clear recurrrence of your cancer through a biopsy (anong other things). There are centers carrying out this trial at many places in the country, and it is usual for such clinical trials to be conducted at limited or no cost to the patient. You would also not have to go to Mexico. On the other hand, Dr. Scionti does have extensive experience as a practitioner of HIFU and at least some of his patients are enthusiastic about HIFU and its potential.

  10. Kent,

    Dr. S. Scionti is in charge of the trial for radiation failure using HIFU in NYC. … I hope that you are qualified for it, it’s free.

    I had HIFU with Dr. Scionti, and you won’t find a better doctor. I’ve sent several friends to him; all are very happy they found HIFU and him. I’ve never read any disparaging remarks about him, although he did tell me that he feels badly about his first 20 patients. he has treated close to 1,000 now (I think).

    Much good luck.

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