High-intensity focused ultrasound (HIFU) is legally available in Canada as a method for the treatment of prostate cancer. However, a new Canadian practice guideline states that, “HIFU cannot currently be recommended as an alternative to accepted curative treatment approaches for localized prostate cancer.”
The new guidance document has been issued by the Genitourinary Cancer Disease Site Group of Cancer Care Ontario’s Program in Evidence-Based Care, and the full text of the guideline is available on line.
The guidance is based on a review of 29 studies of HIFU (using both the Ablatherm and the Sonoblate devices) as primary therapy and a further five studies of HIFU when used as salvage therapy in men who had failed a prior treatment.
The guidance document includes the following additional statements:
- “HIFU should be considered an investigational treatment, with its use restricted to clinical trials, and to patients for whom other local treatment options are not suitable.
- “The results from case series of HIFU require confirmation in well-designed prospective studies of sufficient size with appropriate (and validated) end points before HIFU can be considered a standard treatment option.”
- “The common complications (medians) associated with HIFU [when used as a first-line treatment] included impotence (44% among previously potent patients), urinary tract infections (7.5% of patients), urethral stricture (12.3%), stenosis (7.8%), urinary incontinence (8.1%), urinary retention (5.3%), chronic perineal pain (3.4%) and urethrorectal fistula (1.0%).”
The “New” Prostate Cancer InfoLink expects that this guidance document will be distressing to men whose clinical outcomes to date suggest that they have been treated successfully with HIFU. However, we also believe that the document reflects the failure of the developers of HIFU technology to adequately fund and ensure the completion and publication of well-designed studies designed to demonstrate the effectiveness and safety of HIFU as a treatment for localized prostate cancer.
As we have indicated previously, we are aware of only one large, published case series that clearly reports data on the use of HIFU in a manner sufficient for evaluation of this technique as a first-line treatment for localized prostate cancer.