A prospective clinical trial of HIFU hemiablation for clinically localized prostate cancer

Background:focal therapy is an emerging mini-invasive treatment modality for localized prostate cancer aimed to reduce the morbidity associated with radical therapy while maintaining optimal cancer control. we report the mid-term oncological and functional results of primary hemiablation high-intensity focused ultrasound (hifu) in a prospective cohort of patients.methods:over 8 years, hemiablation hifu was primarily performed in 50 selected patients with biopsy-proven clinically localized unilateral, low–intermediate risk prostate cancer in complete concordance with the prostate cancer lesions identified by magnetic resonance imaging with precise loci matching on multimodal approach. post-treatment follow-up included regular serial psa measurements. biochemical recurrence was reported using stuttgart and phoenix criteria. the latter was used as a threshold to offer whole-gland biopsies.results:complete follow-up was available for all patients and the median follow-up was 39.5 months (range: 6–94). mean nadir psa value was 1.6 ng ml−1, which represents 72% reduction compared with initial psa pre-treatment value (p<0.001). median time to achieve psa nadir was 3 months. biochemical recurrence, according to phoenix and stuttgart definition, occurred in 28 and 36% of patients, respectively. the 5-year actuarial metastases-free survival, cancer-specific survival and overall survival rates were 93, 100 and 87%, respectively. out of the eight patients undergoing biopsy, six patients had a positive biopsy for cancer occurring in the untreated contralateral (n=3) or treated ipsilateral lobe (n=1) or bilaterally (n=2). a clavien–dindo grade 3b complication occurred in two patients. complete continence (no pads) and erection sufficient for intercourse were documented in 94 or 80% of patients, respectively.conclusion:hemiablation hifu therapy, delivered with intention to treat, for carefully selected patients affords mid-term promising functional and oncological outcomes. the effectiveness of this technique should be now compared with whole-gland radical therapy.