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

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    Validity and generalisability of the studies

    • Focal HIFU was typically used as primary treatment for localised prostate cancer, though 1 systematic review (Khoo 2020) found 3 studies that used focal HIFU in a salvage setting.

    • There was a total of approximately 5,000 people included in the key evidence studies. More were included in the studies listed in appendix.

    • The focal HIFU treatment protocol was similar between studies. There were differences in the ablative patterns used.

    • A large amount of the data came from the UK-based HEAT registry (Reddy [2022], Lovegrove [2020], and van Son [2021]). This registry prospectively collected consecutive people who had focal HIFU. One further study (Stabile [2019]) was a retrospective analysis of a large cohort of consecutive UK people. It is therefore likely that the outcomes found by these studies are generalisable to UK clinical practice.

    • There was limited comparative evidence in the literature. There are several ongoing RCTs (refer to Issues for consideration by IPAC), but none have yet published oncological or functional outcomes. A feasibility RCT (Hamdy, 2018) is listed in the appendix and found that randomisation of men to an RCT comparing partial ablation with radical treatments of the prostate is feasible.

      • Comparative safety evidence came from a meta-analysis of complications (He, 2020).

      • Comparative efficacy evidence came from a propensity score weighted analysis of focal therapy (mostly focal HIFU) versus radical therapy (van Son, 2021). This is a quasi-experimental study design that aims to mimic the unbiased treatment assignment of randomisation by giving more weight to those people with baseline characteristics that mean they could be assigned to either treatment group. However, it cannot account for unknown covariates.

      • A further comparative study of partial-gland versus whole-gland HIFU was also included (Byun, 2022). The findings of this study were limited by the retrospective design, high attrition, and statistically significant differences in baseline characteristics of the groups.

    • The longest median follow up reported was 82 months. This was recorded in a subset of people in the HEAT registry who had more than 5 years of follow up (Reddy, 2022).