INTRODUCTION: Focal therapy using HIFU has been shown to provide encouraging short-term disease control with a low genito-urinary side effect profile. We report on the medium-term oncological and functional outcomes from our UK prospective academic HIFU registry across 8 centres. .

METHODS: 625 patients diagnosed with T1aN0MO to T3bN0M0 prostate cancer after multi-parametric MRI, transperineal and/or MR-targeted biopsies and were treated with focal HIFU. 

RESULTS: Of 625 patients, 80 (13%), 491 (81%) and 39 (6%) had low, intermediate and high-risk disease. At 1-2 years and 2-3 years post-op, at baseline and follow-up; 305 (97%) and 241 (98%) were pad-free, respectively. At 1-2 years and 2-3 years after focal-HIFU, continence status was 209 (83%), and 156 (80%) were pad-free, leak-free continent. 

At 1-2 years and 2-3 years, at baseline and follow-up; 138 (84%) and 87 (86%) maintained erectile function, respectively. Two (0.8%) developed a recto-urethral fistula of which one healed with urinary diversion alone and the second required operative reconstruction.

Overall, 29/625 (4.6%) were found to have in-field recurrence on 12 month post-op biopsies. 16 (2.6) out-of-field de novo disease or progression and 11 (1.8%) had both. 122 (20%) had a further focal-HIFU treatment, whilst 44 (7%) transitioned to radical whole-gland therapy. The metastasis-free survival, prostate-cancer specific survival and overall survival at 5 years were 97%, 100% and 99% respectively.

CONCLUSIONS: Focal HIFU has acceptable rates of cancer control in men with clinically significant prostate cancer with a low genito-urinary side-effect profile in the medium-term and across a number of centres.