Visually directed high‐intensity focused ultrasound for organ‐confined prostate cancer: a proposed standard for the conduct of therapy

OBJECTIVE To propose a standard for the conduct of visually directed transrectal high‐intensity focused ultrasound (HIFU) and to offer a formal description of the changes observed on B‐mode ultrasonography (US) during this procedure. We describe our early experience of using two different treatment methods; algorithm‐based HIFU and visually directed HIFU for the treatment of organ‐confined prostate cancer. PATIENTS AND METHODS Between November 2004 and October 2005, 34 men were treated using the Sonablate®‐500 (Focus Surgery, Indianapolis, IN, USA) as primary therapy for T1 or T2 prostate cancer. None had had previous hormone therapy and all had ≥ 3‐month PSA nadirs recorded at the follow‐up. Nine men were treated using an algorithm‐based protocol (group 1) and 25 using visually directed therapy (group 2). The conduct of visually directed treatment was described and changes seen using B‐mode US were categorized using three ‘Uchida’ grades. RESULTS The mean PSA nadir achieved in group 2 was 0.15 ng/mL, vs 1.51 ng/mL in group 1 ( P < 0.005). In group 2, 21 of 25 men achieved PSA nadirs of ≤ 0.2 ng/mL 3 months after treatment. Seven men achieved undetectable PSA values. The occurrence rate of treatment‐related toxicity was similar in both groups. CONCLUSION Visually directed, transrectal HIFU enables clinically important and statistically significantly lower PSA nadirs to be achieved than algorithm‐based HIFU. This is the first reported experience of visually directed HIFU for the treatment of organ‐confined prostate cancer. We think that this is the first attempt to standardize the conduct of therapy; such standardization facilitates teaching it, and makes it possible to derive quality standards. The standardization of the conduct of therapy is a key step in the process of health technology assessment.