title: A prospective clinical trial of HIFU hemiablation for clinically localized prostate cancer.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Urology, Jules Bordet Institute, Brussels, Belgium.
authors.forename: R
authors.initials: R
authors.lastname: van Velthoven
authors.affiliation: Department of Urology, Jules Bordet Institute, Brussels, Belgium.
authors.forename: F
authors.initials: F
authors.lastname: Aoun
authors.affiliation: Department of Urology, Jules Bordet Institute, Brussels, Belgium.
authors.forename: Q
authors.initials: Q
authors.lastname: Marcelis
authors.affiliation: Department of Urology, Jules Bordet Institute, Brussels, Belgium.
authors.forename: S
authors.initials: S
authors.lastname: Albisinni
authors.affiliation: Department of Urology, Jules Bordet Institute, Brussels, Belgium.
authors.forename: M
authors.initials: M
authors.lastname: Zanaty
authors.affiliation: Department of Radiology, Jules Bordet Institute, Brussels, Belgium.
authors.forename: M
authors.initials: M
authors.lastname: Lemort
authors.affiliation: Department of Urology, Jules Bordet Institute, Brussels, Belgium.
authors.forename: A
authors.initials: A
authors.lastname: Peltier
authors.affiliation: Department of Urology, Jules Bordet Institute, Brussels, Belgium.
authors.forename: K
authors.initials: K
authors.lastname: Limani
mesh_terms: D000368:Aged; D001706:Biopsy; D018572:Disease-Free Survival; D057086:High-Intensity Focused Ultrasound Ablation / Q000379:methods*; D006801:Humans; D008297:Male; D011467:Prostate / Q000473:pathology* / Q000528:radiation effects; D017430:Prostate-Specific Antigen / Q000378:metabolism; D011471:Prostatic Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D016879:Salvage Therapy; D016896:Treatment Outcome
chemical_list: D017430:Prostate-Specific Antigen