Update of HTA of high-intensity focused ultrasound (HIFU) for the treatment of prostate cancer in Austria

High-intensity focused ultrasound (HIFU) uses ultrasound (US) waves to cause tissue damage. The energy of the US waves is absorbed by the target tissue and converted to heat (exceeding 60 °C), causing coagulative necrosis. Inertial cavitation is created by alternating cycles of compression and rarefaction.  To execute HIFU, a probe is inserted into the rectum (or urethra) while the patient is anaesthetized. This probe enables real-time visualization of prostatic tissue and also delivers HIFU energy to destroy the desired target parenchyma.  Two major systems of HIFU exist, based on the type of imaging guidance during the treatment:

• HIFU with (transrectal ultrasonography) TRUS imaging guidance is the traditional approach. TRUS guided HIFU is used to ablate the whole prostate gland or a relatively large region
• The novel method is the HIFU system with MRI guidance. It is possible to localize the lesions within the prostate with MRI. Hence the focal treatment (FT) of the prostate is also possible

This assessment is an update of the 2010 version. Therefore the systematic literature search was performed from January 2010 to December 2017 in four databases (Cochrane Library, Centre for Research and Dissemination, Embase, Medline), complemented by manual search in the reference list of relevant studies. In addition, clinical trials databases were searched to identify ongoing studies on HIFU for prostate cancer treatment. The quality of the evidence was assessed using GRADE tool.

The authors have reviewed current evidence on efficacy and safety of high-intensity focused ultrasound (HIFU) as primary or salvage therapy compared to radiotherapy (RT), active surveillance (AS), watchful waiting (WW), and radical prostatectomy (RP) in the treatment of low and intermediate-risk localized or locally recurrent prostate cancer.

Conclusion

The authors have concluded that the current evidence is not sufficient to prove that primary HIFU, as well as salvage HIFU, is more effective and safe or as effective, but safer than the comparators AS, WW, RP or RT. Thus, the inclusion in the hospital benefit catalogue is currently not recommended. There is a need for prospective RCTs with a higher number of patients and longer follow-up in order to be able to determine if HIFU is a suitable alternative to deferred treatment and/or radical therapies.

Overall, since the current evidence is insufficient to demonstrate the efficacy and safety of both primary and salvage HIFU compared to other interventions the inclusion in the BMG catalogue of procedures is currently not recommended.

See the full report in English (with summary in German) here.

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