Finally … Some real 5-year outcome data on HIFU, but were the right patients being treated?

“Medium term outcomes” data following first-line treatment with high-intensity ultrasound (HIFU) are to be presented at the upcoming annual meeting of the American Urological Association.

Dickinson et al. will present data on 570 men, all treated with first-line, whole-gland HIFU (using Sonablate 500 technology) for primary, non-metastatic prostate cancer at eight UK-based centers between October 2004 and June 2012. All data were collected into a national registry. (To find the original abstract, click here and look for abstract no. 553.)

Rates of biochemical progression-free survival (bPFS) were evaluated for all patients based on both the Phoenix criteria (PSA nadir + 2 ng/ml) and the Stuttgart criteria (PSA nadir + 1.2 ng/ml) for men with at least 6 months of follow-up data after final HIFU treatment. Histological outcomes are also reported for those men receiving post-operative “for cause” biopsies.

Here are the study findings:

  • The patients’ average (median) PSA level at baseline was 6.9 ng/ml (range, 0.1 to 74.7 ng/ml).
  • Based on the D’Amico risk criteria:
    • 23 percent of patients had low-risk disease.
    • 34 percent of patients had intermediate-risk disease.
    • 43 percent of patients had high-risk disease.
  • 193/570 patients (33.8 percent) received neoadjuvant androgen deprivation therapy (ADT).
    • For 116 of these patients, the objective was reduction in the size of the gland (“cytoreduction”) prior to HIFU.
  • The average (mean) number of HIFU treatments was 1.3.
  • The average (median) follow-up period was  57 months.
  • The patients’ median nadir PSA level was 0.33 ng/ml (range, < 0.1 to 30.4 ng/ml).
  • 512/570 patients (89.8 percent) had a minimum of 6 months of follow-up, and among these patients
    • bPFS according to the Phoenix criteria was 84 percent.
    • bPFS according to the Stuttgart criteria was 75 percent.
  • Post-HIFU biopsies were performed “for cause” in 197/570 patients (34.6 percent).
    • 75/197 patients (38.0 percent) had a positive histology (i.e., 75/512 patients followed for at least 6 months or 14.6 percent).
  • 119/570 patients (20.9 percent) received adjuvant hormone ablation.
  • 55/570 patients (9.6 percent) received alternative forms of salvage treatment.
    • 46/55 patients (84 percent) received external beam radiotherapy.
    • 5/55 patients (9 percent) were given a radical prostatectomy.
    • 3/55 patients (5 percent) were treated with systemic chemotherapy.
    • 1/55 patients was treated with salvage cryotherapy.

The authors conclude that, “Whole-gland HIFU is a therapeutic option for prostate cancer that is repeatable and delivered within a day case setting with favorable medium term disease-free outcomes.”

This is not exactly a “ringing endorsement” for HIFU. However, it appears very clear to The “New” Prostate Cancer InfoLink that something like 25 to 30 percent of the patients treated may never have been good candidates for HIFU in the first place (given the apparent need for “for cause” biopsies in nearly 35 percent of patients and for relatively aggressive forms of follow-up therapy in just over 30 percent of men). One is tempted to wonder why such a high percentage of the men in this study had high-risk disease (which may not even have been localized in some men, given PSA levels as high as 74.7 ng/ml).

Regrettably, this abstract also provides no data on the complications or side effects of HIFU that may have been associated with treatment.

5 Responses

  1. Data released without side effect/complication analysis are worse than meaningless, They are intentionally misleading and can, by definition, provide no information to consumers to facilitate informed decision-making. Lies of omission are lies equal to lies of commission.


    I have not been a fan of HIFU as results at the 5-year point have generally been distinctly inferior to 5-year results for better established therapies, a pattern repeated with dismaying consistency in several geographic areas. Moreover, serial follow-up studies have revealed a pattern of success rates that fall disturbingly fast around the fourth year and later. (These inconvenient but well-established facts are in stark contrast to the public relations campaigns for HIFU, which often tout results with very short follow-up, such as 1 or 2 years.)

    However, I’ll admit I’m impressed and a little surprised by the success rate (Phoenix) at a median follow-up of nearly 5 years of 84% for the whole group, which has a large proportion of intermediate- and high-risk cases. Am I missing something here, or is this really some welcome news finally for HIFU? If the reported results are not misleading, I’m wondering if something special in the UK treatment protocols was responsible for boosting the success rates at 5 years above what we have seen at a number of other locations with Sonablate 500 HIFU.

    I am disappointed in the absence of two views of the data that strike me as essential for any HIFU study, in view of past success rates that were disappointing: a breakout showing success and median duration of follow-up by risk group, and for each risk group a graph showing the success rate at each year of follow-up. (I read the abstract, and neither was indicated.)

    What is the point of reporting success rates for study populations of severely mixed risk groups of prostate cancer patients? I’m thinking the success rates for the low- and intermediate-risk groups are bound to be substantially better than 84% when the large number of high-risk cases is subtracted out and the remaining results recalculated, but it sure would be nice to know. For those of us with a statistical view of the world, such reporting is really frustrating!

    All that said, this may be very good news!

  3. Dear Jim:

    This is an abstract of a paper that is still to be presented. Who knows how the authors may actually present the data in San Diego in May?

  4. There are several comments regarding this article:

    (1) Primary HIFU should be limited to low- to medium-risk patients. High-risk patients generally do poorly with any and all types of monotherapy, and perhaps a combination of HIFU followed by EBRT may be an option (as may HIFU and 2 years of hormone therapy — as recommended by medical and radiation oncologists around the world).

    (2) HIFU is extremely sensitive to the operator’s experience, meaning the individual performing the procedure, as well as experience over time.

    I have had very satisfying results with the Sonablate HIFU technology, and feel that in the properly selected patient it provides a comparable clinical outcome to other forms of therapy for localized prostate cancer. Equally important, it preserves the quality of life issues important to men seeking a non-invasive treatment (i.e., potency and urinary continence). Additionally, it is a non-invasive outpatient procedure that can be repeated in the event of a recurrence; in addition, all the other the original treatment options remain viable should the patient wish to consider them.

  5. “HIFU is extremely sensitive to the operator’s experience, meaning the individual performing the procedure, as well as experience over time.”

    Very true, but that is not any different for prostatectomy, any type of EBRT, brachytherapy, or cryotherapy.

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