Further experience with salvage HIFU after first-line EBRT

A second, small study has now offered additional data on clinical experience of the use of high-intensity focused ultrasound (HIFU) as a form of salvage therapy in men initially diagnosed with localized prostate cancer, but with a rising PSA after external beam radiation therapy (EBRT) as their first-line treatment.

Giovanessi et al. report having treated 12 such men with biochemical recurrence between February 2009 and June 2010. (Another 2 patients were initially selected for treatment, but were subsequently excluded because of the presence of rectal strictures induced by their EBRT.) All 12 patients had a positive TRUS-guided biopsy; the absence of evident distant metastases was confirmed by CT scans, PET scans, and/or or bone scans. Post-HIFU progression was defined by the use of the Stuttgart definition ( a PSA level higher than the PSA nadir + 1.2 ng/ml).

Here are the basic findings of their study:

  • The 14 patients initially considered to be eligible for the trial were classified according to the D’Amico criteria.
    • 4 patients were high risk.
    • 8 patients were intermediate risk.
    • 2 patients were low risk.
  • Average (mean) follow-up was 13 months from HIFU.
  • At the mean follow-up, biochemical success was reported in
    • 1 high-risk patient
    • 5 low and intermediate risk patients
  • 1 patient treated with HIFU died from a condition not associated with the recurrence of his prostate cancer.
  • Complications of treatment included urinary tract infection, acute urinary retention, urethral stricture, and mild stress incontinence.

The authors conclude that, in their experience, HIFU can be used safely as a therapeutic option for salvage therapy in men with local, biochemical recurrence relapse following first-line EBRT. However, they also emphasize that success in the use of HIFU as a salvage therapy nder these circumstances is dependent on carefull patinet selection.

It is worth noting that in this small series of patients the authors are reporting a 50 percent clinical success rate at an average of a year after treatment. This is not exactly a long-term endorsement of salvage HIFU in this series of patients.

12 Responses

  1. More proof that HIFU works.

    When will patient care and responsibility trump money? Think of the men who wouldn’t have to be humiliated by the prostate cancer treatments that are promoted now, and just think of the possible savings to Medicare.

  2. Dear Ron:

    What do you have to say to the 50% of the men in this study who failed salvage HIFU?

  3. Well heck, they already failed radiation. Betcha they’d be a whole lot happier if they had been treated with HIFU in the first place. It’s not like HIFU has stopped them from trying something else now — is it?

    … just sticking up for the common guy who can’t afford HIFU. If the FDA was fair and honest they’d approve HIFU … It’d save us zillions in health care costs … and if it doesn’t work we can always do it again or take another road.

  4. Oh … I see … If HIFU works, it’s good. If HIFU doesn’t work, it’s still good! Now there’s a truly unbiased approach to health care … one used by radiation oncologists and surgeons regarding the ways they have been treating prostate cancer for years … and now you are willing to coopt that same approach?

  5. Yes. If it doesn’t work it is still good, as the chance of side effects is so low, and they can still go in for other treatments. Now in these guys’ cases, they are already compromised from the radiation.

    Fact is, sometimes it takes two HIFU treatments to get all of the cancer. HIFU was a walk in the park for me, so I don’t see a second round as a big deal. If it was approved it would be quick and easy, but now it means another trip out of the country and another $10k.

    If I heard of a better approach I’d be on that bandwagon, anything to stop the misery. Maybe that 50% should try hormonal treatment?

  6. Dear Ron:

    You seem to be missing the entire point. This is not about the merits of HIFU as a first-line treatment. It is only about the potential of HIFU as salvage therapy after radiation (which you may not have been interested in, but others are).

    The data suggest that HIFU may have at least a short-term value in about half of this small group of patients. But there clearly were side effects, so please don’t simply say that “the chance of side effects is so low” when it clearly wasn’t in these patinets who had previously received radiation therapy. And your personal experience with HIFU as a first-line therapy is irrelevant in men like this.

  7. I get the story, and I’m very interested, I’m just saying that this proves HIFU works after radiation, which means it works … period.

    The side effects they had were most likely brought on by the fact they had radiation first. Or, how much experience did the doctors have with HIFU? Side effects after first-line HIFU is very rare.

    Stephen Scionti is running HIFU after failed radiation studies in NYC and he is claiming a much better success rate, I think he said 85%.

  8. Dear Ron: You keep citing Dr. Scionti as the authority we should listen to, but … So far there isn’t a single paper about HIFU with his name on it if you do a PubMed search! Where is the academic rigor?

  9. As you know, they cannot publish the data on HIFU in salvage therapy until the FDA-approved pivotal trial is over. The trial is being directed by Dr. Lepor at New York University’s Langone Medical Center. They have enrolled and treated 10 patients at NYU and have completed their quota. There are numerous other academic centers in the USA that are part of this trial. The results will be published upon conclusion of the trial.

  10. Ron:

    Yes … I do indeed understand about the STAR trial.

    However, Dr. Scionti has supposedly treated hundreds of patients (you included) with first-line and repeat HIFU over the past few years. How come data from that series of patients have not been collected and reported? I am not aware of any reason why Dr. Scionti should not have been able to publish these data. Are you? I would have thought that the people at US HIFU would have encouraged this. As we both noted some time ago, Dr. Emberton and colleagues in the UK reported data on a series of 100+ patients with no problem (including the fact that there were some side effects).

  11. I had the HIFU procedure for my Gleason 6 prostate cancer at the Heidelberg Klinik for Prostata in Germany 2 weeks ago. I had to wear a catheter for 10 days after the procedure and spent one night in the hospital for observation. The procedure was performed by Dr Dill; the treatment was a “piece of cake” and I felt real good the day after the procedure and I drove home.

    Now two weeks later I feel great but yet have to know whether my sexual organ will work, but I am told it takes some months after the procedure to find out. Dr. Dill told me though, that I should not have any problems.

    Dr Dill’s fee plus hospital stay for one night cost €9,200 (about US$12,660) and the two MRI’s I had cost €1,000 each (about US$1,375) so the whole cost was €11,200 (about US$15,410).

    Don’t hesitate to contact me should anyone have any questions.

  12. The use of HIFU as a first-line treatment for localized prostate cancer is evolving. Early technology has been replaced by newer technology. We still need reliable 10-year follow-up data, however, to know just how safe and effective HIFU really is as a first-line treatment.

    Erectile dysfunction does appear to be a real and relatively common side effect of HIFU. There are clear data that demonstrate the existence of this side effect, and men who are told that HIFU comes with few or no risks need to appreciate that every form of first-line treatment for prostate cancer comes with risks and complications.

    It also has to be noted that Henry’s Gleason 6 prostate cancer might have been eminently well managed with active surveillance as opposed to any form of invasive therapy. We don’t know because we don’t know all sorts of things about his diagnosis.

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