Preliminary safety and efficacy results with robotic high-intensity focused ultrasound : A single center Indian experience

Abstract

BACKGROUND: There are no Indian data of high-intensity focused ultrasound (HIFU). Being an alternative, still experimental modality, reporting short-term safety outcome is paramount. AIMS: This study was aimed at to assess the safety and short-term outcome in patients with prostate cancer treated by HIFU. SETTINGS AND DESIGN: A retrospective study of case records of 30 patients undergoing HIFU between January 2008 to September 2010 was designed and conducted. MATERIALS AND METHODS: The procedural safety was analyzed at 3 months. Follow-up consisted of 3 monthly prostate-specific antigen (PSA) levels and transrectal biopsy if indicated. All the patients had a minimum follow-up of 6 months. RESULTS: A mean prostate volume of 26.9 ± 8.5 cm(3) was treated in a mean time of 115 ± 37.4 min. There was no intraoperative complication. The postoperative pain visual analogue score at day 0 was 2.1 ± 1.9 and at day 1 was 0.4 ± 0.8 on a scale of 1-10. Mean duration of perurethral catheter removal was 3.9 days. The complications after treatment were: LUTS in seven patients, stress incontinence in two, stricture in two, and symptomatic urinary tract infection in five. Average follow-up duration was 10.4 months (range, 6-20 months). Mean time to obtain PSA nadir was 6 ± 3 months with a median PSA nadir value of 0.3 ng/ml. Two patients had positive prostatic biopsy in the localized (high risk) group. CONCLUSIONS: HIFU was safe in carcinoma prostate patients. The short-term results were efficacious in localized disease. The low complication rates and favorable functional outcome support the planning of further larger studies.