A targeted and minimally invasive treatment for prostate cancer called focal therapy, which destroys only the cancerous part of the prostate, is effective in delivering long term outcomes for patients, according to a new study.
Published in the journal European Urology, the study, supported by National Institute for Health and Care Research (NIHR) infrastructure and a research fellowship, by researchers at Imperial College London and Imperial College Healthcare Trust is the largest of its kind. It reveals that 10 years after focal therapy treatment, only two men out of nearly 3,500 in the study had died from prostate cancer. This very low mortality rate matches prostatectomy surgery and radiotherapy.
Prostate cancer is the most common cancer in men, with more than 60,000 men diagnosed each year in the UK alone. Many of these cancers are confined to the prostate, and these men are offered either robotic surgery to remove the prostate (radical prostatectomy), or radiotherapy delivered to the whole prostate. Both are effective treatments but can cause long-lasting side effects, such as urinary incontinence and erectile dysfunction. These harms are one reason why the National Screening Committee recently advised against screening all men for prostate cancer.
Far fewer side effects with focal therapy
Around half to two-thirds of these localised cancers are suitable for focal therapy – that’s up to 15,000 men per year in the UK. Focal therapy leads to a five-fold lower risk of side effects such as incontinence, erectile dysfunction and rectal problems compared to traditional radiotherapy or surgery because it only targets the areas of cancer. This minimises damage to healthy prostate tissue and those nerves and muscles next to the prostate which control urinary and sexual function.
In this new study, the Imperial team worked with 14 hospitals across the UK to follow 3,477 men who had received focal therapy using a heat-based treatment (high intensity focused ultrasound, also known as HIFU) or a freezing-based treatment (cryotherapy) between 2004 and 2024. They discovered focal therapy effectively controlled prostate cancer, even in higher risk disease:
- Nine in 10 men had intermediate or high-risk cancer – cancers that should not just be monitored, but should be treated
- 10 years after treatment, just two men across the study had died from their prostate cancer (0.1%) and three in 100 (3%) had seen their cancer spread outside the prostate. These rates are similar to rates seen with surgery or radiotherapy treatment
- One in three men needed further treatment, with some men choosing to have radical prostatectomy or radiotherapy even though they could have had further focal therapy. Out of those men who had two sessions of focal therapy, only one in ten needed to have prostatectomy or radiotherapy due to a persistent cancer. In comparison, 15 per cent to 30 per cent of men with similar prostate cancer risk who undergo prostatectomy or radiotherapy have cancer that recurs.
Providing the evidence to underpin care for more men
Focal therapy is already available at some NHS and private centres around the UK, including Imperial College Healthcare NHS Trust. Focal therapy is approved by the NICE HealthTech programme, as long as clinicians collect their data routinely for outcomes in national registries. Awareness of the treatment has risen sharply over the past year with several public figures recently speaking about undergoing focal therapy.
The study provides the evidence needed to underpin frontline care and strengthens the case for more centres to offer focal therapy so more men can access it. As part of its commitment to evaluate screening within the NIHR and Prostate Cancer UK funded TRANSFORM study and ensure that harms of a future screening programme are significantly reduced, the government announced £2.8 million in capital funding to expand focal therapy in line with the TRANSFORM trial expansion throughout the UK.
Study author Dr Alexander Light, NIHR Doctoral Fellow at Imperial College London and urology registrar at Imperial College Healthcare NHS Trust, said: “The results of our study are really encouraging. Ten years on, only two men in the study had died from their prostate cancer and many men have benefitted from the treatment, including men with more aggressive disease who would traditionally have been told focal therapy wasn’t an option for them.”
Joint senior author Professor Hashim Ahmed, consultant urologist and Chair of Urology at Imperial College London and Imperial College Healthcare NHS Trust, who also leads the TRANSFORM screening study, said: “This is the largest and longest running study demonstrating that focal therapy delivers excellent long-term cancer control across a broad range of patients.
“It makes a compelling case for more centres to offer this treatment, and I am pleased to see the government make a firm commitment of capital funding to support it. Right now, only about 1,000 men per year have the treatment, when up to 15,000 men could – and are either not told about it, or do not have local access.”
Joint senior author Dr Taimur Shah, consultant urologist and Associate Professor at Imperial College London and Imperial College Healthcare NHS Trust, said: “Our study now gives clinicians and patients the long-term evidence they have been waiting for.
“We hope these results will help update the main NICE clinical guidelines so that focal therapy is routinely offered as a first-line choice to men. Men who would like to know whether it might be right for them can ask their urologist about referral to a specialist centre that performs these treatments.”
Changing clinical practice as well as conversations
Paul Sayer, Founder of the charity Prost8 UK, said: “I have benefited from focal therapy myself, and this new study is incredibly significant. For too long, many men have believed they had to choose between curing their cancer and preserving the quality of their lives. This study shows that, for many patients, that simply isn’t true.”
He continued: “At Prost8 we’ve helped hundreds of men understand their options and access specialist centres. Our hope is that this evidence marks the point where every suitable man is routinely offered focal therapy as part of his treatment choices, regardless of where he lives.
“This research shouldn’t just change clinical practice – it should change conversations in every consulting room across the UK. Every man deserves to know all of his appropriate treatment options before making one of the biggest decisions of his life.”
Health Innovation and Safety Minister, Preet Kaur Gill, said: “Everyone deserves access to the best possible treatment, and this government is determined to make that a reality. This study is a powerful demonstration of what focal therapy can achieve.
“Our investment of up to £2.8 million, announced earlier this year, will help expand the TRANSFORM trial and ensure more men have access to this treatment through prostate cancer screening. Our National Cancer Plan sets out our ambition to transform cancer care, and backing innovations like focal therapy is exactly how we are delivering on that promise.”
Amy Rylance, Director of Health Services, Equity & Improvement at Prostate Cancer UK, said: “This is truly fantastic news for men. Side effects can be devastating, and this is the first long-term study that shows many men could avoid them without increasing the risk their cancer could return.
“These serious side effects are a major reason we don’t yet screen for prostate cancer and reducing them makes it far more likely we can get to a screening programme for all men sooner.”
Imperial College Healthcare NHS Trust and Imperial College London are designated as a Focused Ultrasound Centre of Excellence. This is a prestigious network of just 16 centres worldwide who have been recognised by the Focused Ultrasound Foundation for advancing the development and adoption of focused ultrasound technology in research, training, and patient care.
Research at Imperial College Healthcare NHS Trust is supported by funding from the NIHR Imperial Biomedical Research Centre (BRC).
The researchers were supported by grants from the NIHR, NIHR & Cancer Research UK Imperial Experimental Cancer Medicine Centre, Prostate Cancer UK, Cancer Research UK and the Wellcome Trust.
