Focal therapy with high-intensity focussed ultrasound (HIFU) is an effective treatment for clinically significant nonmetastatic prostate cancer (PCa) and has a low probability of side effects, according to a new study published in the journal European Urology.
The prospective study recruited 625 consecutive patients with PCa undergoing focal HIFU therapy at 9 centres between 1 January 2006 and 31 December 2015. Disease was localised using multiparametric MRI combined with targeted and systematic biopsies or transperineal mapping biopsies. Areas of significant disease were treated.
Failure-free survival at 1, 3 and 5 years was 99% (95% CI, 98-100), 92% (95% CI, 90-95) and 88% (95% CI, 85-91). Metastasis-free and OS at 5 years was 98% (95% CI, 97-99) and 99% (95% CI, 97-100), respectively. Only 2% had urinary incontinence requiring use of 1 pad per day and no men required more than 1 pad per day. Bowel complications were reported in 0.3%.
The authors acknowledge that the study is not a randomised controlled trial. However, they point out that even if randomisation could be delivered, the sample size would have to be based on a noninferiority design that might require between 2000 and 8000 participants, followed up for 10-15 years.
“Physicians and healthcare organisations will need to consider whether it is justified to insist on randomised comparative data for focal therapy compared to radical therapy powered on mortality and metastases,” the authors say.
They point out that other treatments such as prostate brachytherapy and robotic prostatectomy have been approved for clinical use without or before the completion of randomised comparative studies.
“On the basis of our data, patients currently diagnosed with PCa that is suitable for focal therapy may prefer to have the option to choose whole-gland radical therapy or focal therapy,” they say.
