Clinical Evidence and Published Research
The clinical evidence for focal therapy is drawn from over two decades of published research, NICE-approved registries, and real-world patient outcomes. Based on our one-year outcome audit of 265 patients, 97% maintain urinary continence, 90%+ preserve sexual function, and 90% are cancer-free at one year. At five years, published data shows 88% remain cancer-free (Ganzer et al., 2017). Both HIFU (NICE IPG424) and NanoKnife (NICE IPG768) are NICE-approved for treating localised prostate cancer.
Treatments Completed
and Erectile Dysfunction
Focal Therapy Timeline
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“Active surveillance may be highly effective in monitoring cancer, but for me, it was doing my head in — constantly worrying, not sleeping properly, and with my mind taking me to some very dark places.”
Perry Letcher
The Focal Therapy Clinic patient
NICE approval of focal therapy
To make a decision about HIFU and NanoKnife, NICE reviewed all the data available for them in 2022, including comparing when they were used focally (to target just your tumour) and for your whole gland.
It found that overall survival was higher for people treated with HIFU, compared with radical treatments (97.5% compared with 93.4%). There was a statistically significantly lower incidence of incontinence with focal HIFU compared with whole-gland HIFU. There was a statistically significantly lower incidence of erectile dysfunction with focal HIFU compared with whole-gland HIFU.
Overall survival was also higher for people treated with NanoKnife, compared with radical treatments (99-100% compared with 93.4%). In people fully continent before their procedure, there was generally no incontinence 12 months afterwards. For people that were able to get and maintain erections before their procedure, between 3-7% of people had difficulty doing so 12 months after their procedure. However, there is only a limited number of data available for NanoKnife treatments, as it is newer than HIFU.
At one year after one focal therapy treatment
Of clinically significant cancer is eliminated*
Of men are fully continent*
Of men retain erections*
*Based upon our outcome audit of 265 patients (October 2025) who all had treatment at The Focal Therapy Clinic using advanced MRI-ultrasound fusion technology to ensure treatment accuracy
HEAT and ICE registries
The HEAT and ICE registries collect data on everyone who has had focal therapy in the UK. The HEAT registry logs people who receive HIFU and the ICE registry tracks those who receive cryotherapy. There are similar registries for people in Europe and the US.
All surgeons and health centres in the UK can access the anonymised data held in these registries. The HEAT registry published 7-year outcomes for 1,379 patients across 13 UK centres in European Urology (2022), showing 100% metastasis-free survival. Our GMC-registered consultant urologists have performed over 2,000 focal therapy procedures and contributed to research published in these registries.
Frequently asked questions
The approval required:
- Special arrangements for clinical governance
- Informed patient consent regarding uncertainties
- Prospective data collection in registries
In 2023, NICE updated this guidance (IPG756), strengthening support based on a decade of evidence. NICE also approved NanoKnife (IRE) in July 2023 (IPG768).
Key milestones:
- 2005: UK centres begin HEAT registry data collection
- April 2012: NICE IPG424 recognises focal HIFU
- 2023: NICE updates HIFU guidance (IPG756) and approves NanoKnife (IPG768)
The 2012 Lancet Oncology study by Ahmed et al. was pivotal in securing this recognition.
MRI enabled focal therapy by providing:
- Precise localisation of prostate tumours
- Detailed treatment planning through 3D mapping
- Improved targeting accuracy using MRI-ultrasound fusion
- Reliable post-treatment surveillance without repeated biopsies
A 2021 Radiology publication by Dr Clare Allen and Dr Francesco Giganti noted that mpMRI is essential for patient selection, planning, and follow-up.
The PI-FAB scoring system, developed by FTC specialists, standardised interpretation of post-treatment MRI scans, helping detect recurrence and differentiate it from healing changes.
Without advances in MRI, focal therapy would not have been possible; imaging made precision targeting achievable.
Ahmed et al., Lancet Oncology (2012)
The pivotal prospective study demonstrating focal HIFU's feasibility and early cancer control.
Multicentre 5-Year Outcomes Study (2018)
625 patients showed 100% cancer-specific survival, 98% metastasis-free survival, and 98% pad-free continence.
HEAT Registry (2022)
The largest dataset: 1,379 patients, up to 15 years' follow-up, 100% metastasis-free survival at 7 years, and excellent functional outcomes.
PRESERVE Trial (2025)
121 NanoKnife patients with intermediate-risk disease. Results led to FDA clearance in 2024 with high negative biopsy rates and low complications.
Propensity-Matched Comparison (2021)
Demonstrated equivalent 8-year cancer control to radical prostatectomy but with superior functional outcomes.
By treatment type:
| HIFU | 80,000–90,000 | Manufacturer registries |
| Cryotherapy | 15,000–20,000 | COLD Registry, reviews |
| NanoKnife (IRE) | 5,000–8,000 | Single-centre and trial data |
Evidence in published research:
- 2025 meta-analysis: 4,615 patients across 50 studies
- 2024 meta-analysis: 49 cohorts
- 2021 review: 5,827 patients across 72 studies
- 2023 review: 8,000+ patients across 124 studies
UK data:
- HEAT Registry: 1,379 patients (2005–2020)
- FTC consultants have contributed to research covering over 2,000 patients
Global uptake is growing by around 7,000–8,500 new cases per year.
Cancer control at 5 years:
| Cancer-specific survival | 99–100% (FT) | 95–98% (RP) |
| Metastasis-free survival | 98–100% (FT) | 95–98% (RP) |
| Failure-free survival | 82–88% (FT) | 75–85% (RP) |
A propensity-matched study showed equivalent 8-year cancer control for both treatments.
Functional outcomes:
| Pad-free continence | 93–100% | 60–85% |
| Erectile function preserved | 75–98% | 13–67% |
| Recovery time | Days to 2 weeks | 4–6 weeks |
One study showed HIFU patients had a 90% lower probability of incontinence compared with surgery. Focal therapy can also be repeated if needed, whereas repeat surgery is not possible once the prostate has been removed.
Any questions?
If you've got any questions about your prostate cancer diagnosis or want to know more about HIFU treatment or NanoKnife treatment, don't hesitate to get in touch with our friendly, knowledgeable team.
Contact the team
Learn more about Focal Therapy and Prostate Cancer
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Reference List
HEAT Registry (European Urology, 2022) - Dudderidge T, et al. PMID: 35123819
5-Year Multicentre Outcomes (European Urology, 2018) - Guillaumier S, et al. PMID: 29960750
Focal vs Radical Prostatectomy Comparison (2021) - Tay KJ, Laniado M, Nigam R, et al.
Ahmed Lancet Study (Lancet Oncology, 2012) - Ahmed HU, Allen C, et al. PMID: 22512844
MRI and Focal Therapy (Radiology, 2021) - Allen C, Giganti F, et al. PMID: 33533678
PI-FAB Scoring System (Eur Urol Oncol, 2023) - Giganti F, Allen C, et al. PMID: 37210343
PRESERVE Trial (European Urology, 2025) - PMID: 40685282
2025 Meta-analysis (Eur Urol Oncol) - PMID: 40251100
2024 Meta-analysis (Prostate Cancer Prostatic Dis) - PMID: 39468217
2021 Systematic Review (European Urology) - PMID: 34489140
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