At GFCT Treatment Support, we are committed to advancing the availability of all prostate cancer treatments, especially focal therapies such as High Intensity Focused Ultrasound (HIFU). These minimally invasive treatments can be life-changing for thousands of men each year, offering effective cancer control with significantly reduced side effects compared to radical surgery or radiotherapy. 

Through our work, we’re supporting NHS hospitals by helping equip them with the technology needed to deliver focal therapies. From donations of ultrasound machines to funding scanning capacity, we aim to remove barriers and reduce waiting times - but there’s still a long way to go. 

Despite growing clinical evidence, widespread demand, and evolving global guidelines, focal therapy remains underutilised in mainstream prostate cancer care. Challenges with clinical trial design, outdated national guidance, and institutional hesitancy continue to stall broader adoption. 

We set out below some key issues and factors recently outlined by Professor Hashim Ahmed in relation to the progress being made in getting HIFU and other focal therapies included in mainstream prostate cancer treatments: 

“First, the UK NICE Interventional Procedures Guidelines which are held as equivalent in terms of clinical service commissioning to the overarching NICE Clinical Guidelines support the use of focal therapy using high intensity focused ultrasound or cryotherapy or irreversible electroporation outside of research and outside of clinical trials but within prospective registries. The NICE IPG guidelines that are relevant here are,

• NICE IPG756 (Focal HIFU) (April 2023)
• NICE IPG423 (Focal cryotherapy) (April 2012)
• NICE IPG768 (Irreversible electroporation) (July 2023)

NICE’s guidelines for interpreting NICE Clinical Guidance and Interventional Procedure Guidelines are that all guidelines they issue are valid and it is for individual clinicians and hospitals to apply them according to their clinical judgement. The NICE Clinical Guidance, which looks at the overarching pathway from diagnosis testing to advanced cancer treatment, has not reviewed the section on focal therapy since 2008 but does cross-link to the IPGs in their report.

Second, the European Association of Urology prostate cancer guidelines in 2023 aligned with this guidance and have allowed for focal therapy to be carried out using cryotherapy or HIFU as part of prospective registries outside of clinical trials or research. 

Third, a number of propensity matched comparative studies have demonstrated iso-effectiveness between surgery, radiotherapy and focal therapy in intermediate and high-risk cases over a 5 to 10 year follow-up period. Whilst patterns of recurrence were different due to differences in definition of recurrence and asymmetric use of ADT before radiotherapy for instance, albeit with the presence of residual confounders in such analyses, these data mean that a randomised control trial will need in the order of 1000 to 2000 men just to demonstrate non-inferiority of efficacy at 10 years.

Fourth, there have now been four attempts at conducting randomised controlled trials and it will be impossible to meet such a 1000-2000 RCT target. These include the UK NIHR funded PART RCT, the PCUK funded UK IP4-CHRONOS RCT, and the Oslo FARP RCT. All have showed that recruitment is extremely challenging with prolonged recruitment periods that make carrying out an RCT that could demonstrate cancer control outcomes over a 5 to 10 year period unfeasible. Not only do patients on the whole refuse to be randomised but once they are randomised to the radical arm 1 in 4 to 1 in 3 refused the radical arm allocation whereas only 0-5% refused the focal therapy allocation. This asymmetric compliance mean that studies need to be even bigger than the 800 to 900 pre-specified sample sizes within their protocols. The UK NIHR has funded a second go at PART. The original sample size for this was between 800 and 900 and as a result of the pilot demonstrating very poor recruitment the sample size now has been decreased to approximately 240 and even this new target will be extremely challenging to meet. If and when it is met the outcomes will unfortunately not provide any meaningful clarity on the question it set out to answer whilst the dissemination of focal therapy will continue at a pace.

Fifth, we must keep in mind that a key aspect in arguing against prostate cancer screening are the harms of radical therapy. These have been vastly underestimated and technological improvements in the delivery of prostatectomy and radiotherapy have overestimated the degree to which long-term functional impact has been impacted in a positive manner. We have seen this from the latest randomised controlled trials including CHIPP, PACE-A and large prospective healthcare outcomes studies such as the National Prostate Cancer Audit (NPCA) and Movember/PCUK TruNth. These latest outcome data make the therapeutic ratio of treating early intermediate and high-risk disease that are currently diagnosed with increased awareness and would be found in screening much more challenging in the modern era to justify. Data from diagnostic studies show that about one-third of newly diagnosed men - approximately 10,000-12,000 every year - are suitable for focal therapy.

Sixth, focal therapy in the UK has been offered routine routinely for the last 15 years in some centres. This has been outside of research and clinical trials although we have led the field in delivering prospective clinical trials and research to add to the body of evidence. In a number of thousands of patients with predominantly intermediate and high risk disease with only 5-10% having low risk disease our prospective registry data has shown cancer specific survival of 99.9% with need for further treatment in the order of 10 to 20% and functional impact which is 5 to 10 fold lower in terms of urinary, sexual and rectal toxicity compared to radical treatments. These functional differences have been verified and validated by randomised early data from the UK PART and the Oslo FARP RCT. Indeed, the latter has recently shown at the American Urology Association Annual Congress that cancer control outcomes are similar in the medium term in over 200 patients randomised.

Finally, as a consequence of all of these factors, a number of NHS centres are now routinely offering focal therapy in the UK with numerous others ready to go in the next 12 months. These include Imperial, UCLH, Southampton, Basingstoke, Wirral Arrow Park, Bath, Kings Lynn, PRUH/Kings, and Northampton. A number of additional centres are within 12 months of starting focal therapy services. These include Birmingham, Luton, Newcastle, Royal Liverpool, Stockport, Edinburgh, Fife, Plymouth, Maidstone and Kent, Norfolk and Norwich, Leeds and active discussions in Northern Ireland and Wales are underway.”

Learn more about GFCT Treatment Support and how you can support the project - https://gfcttreatmentsupport.co.uk

Help change the future of prostate cancer treatment - for today, and generations to come.