Focal therapies

Introduction

For men with non-metastatic prostate cancer, traditional treatments such as surgery and radiotherapy can be highly effective. However, they can also cause life-changing side effects, including problems getting or maintaining an erection and urinary incontinence, which can significantly affect men’s quality of life. 

Focal therapies offer an alternative for some men whose prostate cancer is confined to one area but is considered too high-risk for active surveillance. These highly precise treatments target only the area of the prostate containing clinically significant cancer while preserving as much healthy prostate tissue as possible, potentially reducing the risk of serious side effects.

The main focal therapy techniques currently in use are high-intensity focused ultrasound (HIFU), which uses heat, and cryotherapy, which freezes the targeted tissue. However, there remains considerable debate on how effective focal therapies are, which men are suitable for them, and whether they are ready to be offered routinely alongside surgery and radiotherapy.

New evidence

Although focal therapies are increasingly used worldwide, evidence about men’s long-term outcomes has remained limited. This uncertainty has contributed to their restricted availability across the UK. In July, however, new evidence was published on the use of focal therapies for men with non-metastatic prostate cancer.

The study, published in European Urology and led by Professor Hashim Ahmed and Mr Taimur Shah at Imperial College London, used data from two prospectively maintained UK registries. It included 3,477 men who received either HIFU or cryotherapy and were followed for up to 10 years. The researchers examined how well these treatments controlled prostate cancer over time. Two men died from prostate cancer, representing a cumulative incidence of 0.13%, while 42 men developed metastatic disease, representing a cumulative incidence of 3.3%.

The authors noted in their discussion that clinical trials in this area should still be supported and that further research into the use focal therapies for high-risk prostate cancer is needed, But on the basis of their observational findings, the authors called for focal therapies to be considered alongside surgery and radiotherapy as first-line treatment options for men with non-metastatic prostate cancer.

Media response to the new findings

The findings attracted substantial media attention, with coverage from outlets including the BBC and Oncology News Today. Prostate Cancer UK also highlighted the study through a News and Views article and a Research Spotlight post on the Prostate Cancer UK Researchers LinkedIn channel. As always, our focus was on what the findings could mean for men: longer lives with fewer life-changing side effects.

Letter to the editor

More recently, a letter to the editor published in European Urology questioned both the conclusions drawn from the study and how its findings had been communicated to men through the media.

The letter acknowledges the value of registry studies and accepts that this research is an important first step in establishing whether focal therapy should be part of the treatment choices available to men with localised prostate cancer.

Then the letter raises a number of concerns about the interpretation of the study’s findings and subsequent media coverage.

Firstly, the study’s median follow-up was 3.3 years – only 173 patients (5% of the study population) reached the 10-year follow-up mark. A timeline of 3.3 years was noted as being too short to draw long-term oncological control outcomes.

Secondly, the study did not report functional or quality-of-life outcomes, even though potential improvements in men’s quality of life were a major focus of the media coverage.

Lastly, it highlighted that several major international guidelines still classify focal HIFU and cryotherapy as investigational and do not recommend them as first-line treatments for non-metastatic prostate cancer. The letter argues that a single-arm registry study cannot, by itself, support a conclusion that challenges those guidelines.

New evidence needed

The letter calls for evidence from randomised controlled trials before guideline changes are pursued. Delivering these trials has been difficult because some men and clinicians lack equipoise—that is, genuine uncertainty about which treatment is preferable—which can make recruitment challenging.

The NIHR-funded Partial Prostate Ablation versus Radical Prostatectomy (PART) trial aims to help address this evidence gap. The trial has introduced measures to overcome challenges around equipoise (Elliott et al., 2019) and has recruited 200 men so far (part-trial.octru.ox.ac.uk). Its findings should provide important evidence about the role focal therapies could play in men’s treatment choices.

Final thoughts

Men with localised prostate cancer can experience life-changing side effects following treatment. As an organisation, it is imperative that we give these men a voice and challenge governing bodies such as NICE to reassess guidance based on emerging evidence. But, perhaps as a research community we still need to provide more evidence to support the use of focal therapies as a first-line treatment for men with non-metastatic prostate cancer.

We’d love to hear your thoughts on this topic and how you think this field will develop in the future. Get in touch!