To report oncological and functional outcomes of focal HIFU (hem ablation) treatment in patients with unilateral local recurrence after radiotherapy.
This clinical study was designed as a Phase IIb multi-center, prospective, open label, single group assignment study, conducted in France and Norway. This study was conducted under IRB and ethic committee approval. The studied strategy is a hemi HIFU ablation treatment limited to the prostate lobe where the prostate cancer recurrence after initial EBRT is detected. Patients were followed-up within a long-term follow-up period to evaluate the failure free survival defined as either positive biopsy, salvage treatment, metastasis or death due to Pca. Failure free survival was defined as either positive biopsy, any salvage treatment (focal, radical or systemic), any metastasis or death due to Pca.
Between September 2010 and May 2018, 93 patients have been enrolled, 88 has been treated, and 87 have been analyzed in 3 centers: 66 patients in 2 French centers and 21 patients in 1 Norwegian center. The mean age of the subjects was 71.5 years old; the mean PSA value and median Gleason score were 5 ng/mL and 7 (vs 13.4 ng/mL and 7 at diagnosis) respectively, including 33% of high-risk patient.
At 5-years, the overall, metastasis-free, androgenic deprivation treatment-free and failure-free survival rates were 97.3%, 85.8%, 57.4% and 47.4% respectively.
There was a significant difference between the initial (pre-EBRT) risk groups on failure-free survival with a 4-years survival rate of 100%, 49.7%, 38.4% and 47.6% for low risk, intermediate, high and unknown risk patients, respectively.
Incontinence grade 2/3 occurred in 22 patients (2 required a surgical procedure). Pubic osteitis occurred in 3 patients (2 medical treatments, and one surgical procedure).
Focal HIFU treatment is a curative therapeutic option in patients with unilateral radiorecurrent PCa associated with a limited urinary morbidity.