8-year bPFS data for 1,000+ French HIFU patients


A French clinical research group has just reported 8-year biochemical progression-free survival (bPFS) data for > 1,000 men with localized prostate cancer treated with first-line high-intensity focused ultrasound (HIFU). We assume that these data were generated using the Ablatherm HIFU technology.

Crouzet et al. treated appropriately eligible patients with localized disease at a single institution using first-line HIFU between 1997 and 2009, and it should be noted immediately that technological improvements through the use of differing “generations” of HIFU technology were applied over that time period, as were modifications to the surgical protocol for use of HIFU. Patients who appeared to have recurrence after a first application of HIFU were often re-treated at least once.

Here are the study findings presented in the abstract of the paper (there may be more details in the full text):

  • 1,002 patients were treated in total.
  • Average (median) follow-up after initial HIFU treatment was 6.4 years (range, 0.2 to 13.9 years).
  • 60 percent of patients received just one HIFU session only.
  • 38 percent of patients received two HIFU sessions.
  • 2 percent of patients received three HIFU sessions.
  • 39 percent of patients received androgen deprivation therapy (ADT) to downsize the prostate prior to HIFU treatment.
  • Nadir post-HIFU data showed that
    • The average (median) nadir PSA post-treatment was 0.14 ng/ml.
    • 63 percent of patients had a nadir PSA post-treatment of < 0.3 ng/ml.
    • It is not clear from the abstract whether these nadir data were after the first or after all HIFU treatments, or whether these nadir PSA levels were potentially affected by the use of neoadjuvant ADT.
  • The 8-year, HIFU-specific bPFS rates (based on the Phoenix criteria of PSA remaining below the nadir PSA level + 2 ng/ml) were
    • 76 percent for men with low-risk disease
    • 63 percent for men with intermediate-risk disease
    • 57 percent for men with high-risk disease.
  • The following salvage therapies were used to treat men with biochemical recurrence post-HIFU
    • External beam radiation therapy (EBRT) alone (in 13.8 percent of patients)
    • EBRT + ADT (in 9.7 percent of patients)
    • ADT alone (in 12.1 percent of patients)
  • The 10-year prostate cancer-specific survival rate was 97 percent.
  • The 10-year metastasis-free survival rate was 94 percent.
  • Severe complications post-HIFU decreased with improvements in HIFU technology
    • From 6.4 percent to 3.1 percent for severe incontinence
    • From 34.9 percent to 5.9 percent for severe bladder outlet obstruction
  • The paper’s abstract provides no data on other side effects or complications of HIFU (including erectile/sexual dysfunction).

The authors conclude that, “HIFU is a potentially effective treatment” for the treatment of localized prostate cancer, with a high 10-year prostate cancer-specific survival rate, a high 10-year metastasis-free survival rate, and “acceptable morbidity.”

The “New” Prostate Cancer Info Link would note only that an 8-year bPFS of 76 percent among low-risk patients would appear to be low compared to outcomes after other forms of therapy, and that at least 25 percent of patients overall appear to have needed some form of salvage therapy within 10 years of their initial treatment. Whether better data than these can be generated by clinical researchers using the Sonablate technology is still to be demonstrated.

3 Responses

  1. I’m always left wanting with studies like this that make no mention of side effects (urinary/sexual).

  2. Me too!

  3. This study makes a great case for not using HIFU; it fails often even in men who don’t need treatment.

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