Primary Zonal High Intensity Focused Ultrasound for Prostate Cancer: Results of a Prospective Phase IIa Feasibility Study.

Abstract

Objectives: To present the results of a prospective phase IIa study assessing the role of primary zonal High Intensity Focused Ultrasound (HIFU) for prostate cancer treatment.

Methods: 31 consecutive patients with unilateral organ confined prostate cancer primarily treated by zonal HIFU (from February 2007 to June 2011) were recruited into a single centre prospective phase IIa feasibility study. Complications were prospectively recorded and graded according to the Clavien-Dindo score. Postoperatively, patients were followed with serial serum PSA determinations and digital rectal examinations. An individual PSA nadir was identified in each patient. Followup also included whole gland biopsies performed in the event of a PSA rising>2.0 ng/mL above nadir value (Phoenix criteria).

Results: At a median followup of 38 months, biochemical recurrence free survival was 100%, 89%, and 82.7% at 1, 2, and 3 years, respectively, with overall and cancer specific survival of 100%. The procedure was safe and well tolerated with no major adverse events. All patients were continent at their last followup and 55.2% (16/29) had erectile function sufficient for penetration.

Conclusion: Primary zonal HIFU is a valid focal therapy strategy, safe and feasible in day to day practice with good promising results [corrected].