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

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    Additional information considered by IPAC

    Professional experts' opinions

    Expert advice was sought from consultants who have been nominated or ratified by their professional Society or Royal College. The advice received is their individual opinion and is not intended to represent the view of the society. The advice provided by professional experts, in the form of the completed questionnaires, is normally published in full on the NICE website during public consultation, except in circumstances but not limited to, when comments are considered voluminous, or publication would be unlawful or inappropriate.

    Seven professional expert questionnaires for focal therapy using high-intensity focused ultrasound for localised prostate cancer were submitted and can be found on the NICE website.

    Patient organisation submissions

    NICE received 2 submissions from patient organisations about focal therapy using high-intensity focused ultrasound for localised prostate cancer.

    Patient commentators' opinions

    NICE received 307 questionnaires from patients who had the procedure (or their carers).

    Patients' views on the procedure were consistent with the published evidence and the opinions of the professional experts. See the patient commentary summary for more information.

    Company engagement

    A structured information request was sent to 2 companies who manufacture a potentially relevant device for use in this procedure. NICE received 2 submissions. These were considered by the IP team and any relevant points have been taken into consideration when preparing this overview.

    Issues for consideration by IPAC

    Several RCTs are ongoing:

    • Focal Prostate Ablation Versus Radical Prostatectomy (FARP; NCT03668652). Randomised controlled trial, open label. Est. enrolment: 200 people; est. completion: September 2024.

    • Phase 3, Multicenter, Randomized Study, Evaluating the Efficacy and Tolerability of Focused HIFU (High Intensity Focused Ultrasound) Therapy Compared to Active Surveillance in Patients With Significant Low Risk Prostate Cancer (HIFUSA; NCT03531099). Randomised controlled trial, open label. Est. enrolment: 146 people; est. completion: October 2026.

    • A randomised controlled trial of Partial prostate Ablation versus Radical prosTatectomy (PART) in intermediate risk unilateral clinically localised prostate cancer (https://fundingawards.nihr.ac.uk/award/12/35/54). Planned in 2 parts – a feasibility study (Hamdy, 2018 in the appendix) and then an RCT (status unknown; https://part.octru.ox.ac.uk/). Est. enrolment: 800 people; est. completion: unknown.

    • Comparative Health Research Outcomes of NOvel Surgery in Prostate Cancer (IP4-CHRONOS; NCT04049747). Randomised controlled trial of radical therapy vs. focal therapy (including HIFU). Est. enrolment: 2450 people; est. completion: May 2027.

    • Additional Treatments to the Local Tumour for Metastatic Prostate Cancer: Assessment of Novel Treatment Algorithms (IP2-ATLANTA) Randomised controlled trial (including HIFU). Est. enrolment: 918 people; est. completion: March 2024.