Focal therapy for prostate cancer: interpreting the latest HEAT and ICE registry data
Dr Philip Camilleri, Clinical Director of Urology at GenesisCare UK, comments on behalf of the GenesisCare UK Urology Clinical Reference Group (CRG) on the letter by Van As, Tree and Ost responding to the updated HEAT and ICE registry analysis.
The GenesisCare UK Urology Clinical Reference Group supports the concerns raised by Dr Van As, Dr Tree and Dr Ost on how the findings from the HEAT and ICE registries have been interpreted and communicated. The registries provide valuable prospective data from 3,477 men treated with focal high-intensity focused ultrasound (HIFU) or cryotherapy for nonmetastatic prostate cancer, and the reported cancer outcomes are encouraging. Estimated 10-year prostate cancer-specific mortality was 0.13%, with an estimated 3.3% incidence of metastasis.
However, these figures need to be interpreted in the context of the maturity of the dataset. Median follow-up was only 3.3 years and just 173 patients (~ 5% of the cohort) had actually reached 10 years of follow-up. Presenting these findings as 10-year outcomes risks giving the impression of mature long-term evidence when most patients had been followed for a substantially shorter period.
Particular caution is also needed around claims that focal therapy results in fewer side effects than surgery or radiotherapy. The study did not report urinary function, sexual function, quality of life or other validated functional outcomes. Preservation of these aspects of quality of life is one of the main reasons for considering focal therapy, but the registry data cannot establish whether it provides a functional advantage over established treatments. Comparative claims of this kind require prospectively collected patient-reported outcomes and, ideally, evidence from randomised trials.
The need for subsequent treatment is another important part of the discussion. In the intention-to-treat analysis, the estimated 10-year incidence of local retreatment was 33%, while 30% of patients were estimated to undergo radical treatment. The paper also presents a post hoc analysis that produces lower rates of radical treatment after censoring some patients. While such analyses may be useful for exploring the data, the observed treatment pathway remains highly relevant when counselling patients. Focal therapy may be followed by a second focal procedure and, for some patients, by surgery or radiotherapy. Each additional intervention can bring further treatment burden and potential morbidity.
These limitations make it difficult to support the conclusion that focal therapy should now be considered equivalent to surgery or radiotherapy or routinely positioned alongside them as a first-line treatment. The findings support continued evaluation of focal therapy in carefully selected patients within prospective trials and registries, but they do not remove the need for stronger comparative evidence.
Focal therapy has clear potential, but it should be assessed against the same evidential standards as other treatments for localised prostate cancer. Mature long-term follow-up, complete baseline staging, prospective functional and quality-of-life outcomes, and well-conducted randomised comparative studies are needed before its relative benefits and risks can be defined with confidence.
Encouraging registry data are an important part of that process, but they should not be communicated to patients as evidence of equivalent cancer control or fewer side effects than established treatments when the study itself does not demonstrate this.
The original letter can be found HERE