Clinical Evidence and Published Research

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 2,500 focal therapy procedures and contributed to research published in these registries. Because randomised trials take a decade to report, registry evidence is what guides men deciding today. As Mr Tim Dudderidge puts it: "We can make a simple statement to men, which is in the medium term, it seems probable that… if you were to go through HIFU, you can be reasonably confident of an equivalent outcome to surgery at around eight years."

The Next Generation of Evidence: The CHRONOS Trials

Registry evidence takes focal therapy a long way, but only a randomised controlled trial — where treatment is allocated by chance rather than preference — can fully remove the bias that affects single-centre case series. That is the job of the CHRONOS programme (trial record: NCT04049747), organised by Imperial College London and now the most important ongoing research in focal therapy.

CHRONOS-A randomises men whose intermediate-risk cancer is MRI-visible and confined to one side of the prostate between focal therapy (HIFU or cryotherapy) and radical treatment — surgery or radiotherapy, whichever the patient would choose. Its primary endpoint is failure-free survival at ten years: no salvage treatment, no metastasis, no death from prostate cancer. CHRONOS-B, now fully recruited, is testing whether prostate-shrinking drugs (bicalutamide or finasteride) given before HIFU improve the precision of treatment; results are expected in the next few years.

Mr Tim Dudderidge, Consultant Urological Surgeon at The Focal Therapy Clinic, is an investigator on the CHRONOS trials. He describes the honest position a recruiting surgeon must take:

"If I can look a patient directly in the eye and say that I do both of these treatments, I am an advocate of both, I'm sitting on the fence here… We're going to let the randomisation take care of the decision making and in the process contribute to a study where eventually we will know which is the best of these treatments."