Terapia Focal HIFU Focal One

  • 29 SEPTIEMBRE, 2015| Otros

    Focal High-intensity Focused Ultrasound
    Targeted Hemiablation for Unilateral
    Prostate Cancer: A Prospective Evaluation of
    Oncologic and Functional Outcomes


    Ernesto R. Cordeiro Feijoo, Arjun Sivaraman, Eric Barret et al. Institut Montsouris, Paris France
    European Urology ePublished July 2015
    Purpose of study: To assess the oncologic and functional outcomes of focal high-intensity focused
    ultrasound (HIFU) hemiablation in unilateral organ-confined PCa.
    Design: Prospective single-center evaluation of HIFU hemiablation for unilateral organ-confined PCa was
    performed from July 2009 through December 2013. Inclusion criteria were unilateral disease, clinical
    stage T1c–T2a, maximum positive biopsies <33%, Gleason score ≤ 7 (3 + 4), PSA <15 ng/ml. Patients
    underwent multiparametric MRI but patient selection was based only upon TRUS Biopsy.
    Results:
    71 patients (mean age 70.2 years) underwent Hemiablation HIFU
    Median follow-up was 12 months.
    67 of 71 subjects had post HIFU biopsy
    MORBIDITY
    Only 10 patients (14%) had any complications - all within the first month
    o 4 (6%) UTI (urinary tract infection)
    o 4 (6%) urinary retention
    o 2 (3%) urinary retention requiring TURP
    FUNCTION (measured with validated questionnaires)
    There was no statistical change of IPSS (which measures BPH symptoms) or Continence Scores
    Mean IIEF-5 (potency questionnaire) decreased from 17.9 to 15.4. This was statistically
    significant.
    11/21 (53%) subjects with no measurable ED pre treatment (IIEF-5>22) maintained this after
    treatment. No additional ED data was presented.
    EFFICACY
    17 subjects (25%) had a positive biopsy: most of these were small volume cancers with
    o At least 13 of 17 had no positive cores with > 2mm of cancer
    o At least 13 of 17 had a total core length (all lengths added together) ≤ 3mm
    10 subjects (15%) had a positive biopsy in the treated lobe; 6 (9%) in the untreated lobe and 1 in
    both sides
    Comments:
    ¡± These results are great – very low morbidity!
    ¡± Incontinence does not appear to be a risk with hemispherical HIFU – consistent with other reports
    ¡± No adverse impact on BPH symptoms
    ¡± The mean IIEF score dropped statistically significantly but only by 2.5 points. Hemispherical HIFU had
    no erectile function impact on over half of subjects who had no ED pre treatment. The degree of
    function decrease (i.e., no ED to mild ED) was not reported.
    ¡± Efficacy results are impressive. Only 15% of subjects had a positive biopsy in the treated lobe – the
    vast majority of which was low volume disease.
    SALES SUMMARY
    ¡± Hemispherical HIFU is a treatment with no lasting urinary function impact! No change in Continence
    Questionnaire Score or IPSS score.
    ¡± Potency preservation appears good with FULL preservation in >50% of subjects. Unfortunately, more
    detail not presented.
    ¡± Efficacy is excellent with <6% of subjects having concerning biopsy results and the door remains open
    for retreatment.

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