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    Interventional procedure overview of focal therapy using high-intensity focused ultrasound for localised prostate cancer

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    Existing assessments of this procedure

    In 2022, the German S3 Evidence-Based Guidelines on Focal Therapy in Localized Prostate Cancer: The First Evidence-Based Guidelines on Focal Therapy were published (Borkowetz, 2022). A systematic review was performed to identify relevant literature. Recommendations were then made via consensus of an expert committee. The following recommendation relevant to focal HIFU was made:

    • 6.44: The available data are insufficient to assess the oncological effectiveness and safety of focal HIFU. Evidence-based statement, level of evidence: 4, 95% consensus.

    In 2018, the European Association of Urology published Focal Therapy in Primary Localised Prostate Cancer: The European Association of Urology Position (van der Poel, 2018). This position statement provides overall recommendations on focal therapy. These recommendations include:

    • Focal therapy can ablate cancer cells, but currently, imaging methods cannot reliably identify all high risk cancer clones within the prostate.

    • The literature suggests that the oncological effectiveness of focal therapy remains unproven due to the lack of reliable comparative data against standard-of-care including active surveillance. We recommend awaiting prospective comparative trial data before implementing focal therapy in routine clinical practice.

    • Focal therapy studies targeting smaller regions of the prostate have reported reduced toxicity compared with whole-gland treatment options, but robust comparative studies with toxicity end points are still lacking.

    • Given the considerable uncertainties regarding the optimal follow up of men treated with focal therapy, people should only be treated within the context of a clinical trial using predefined criteria.

    • Better understanding of the toxicity of secondary treatments and retreatments after focal therapy is needed, and its assessment should be part of prospective investigations.