ABSTRACT
OBJECTIVE: Focal therapy is an emerging approach to the treatment of localized prostate cancer. The purpose of this study was to report the 6-month follow-up oncologic and functional data of the initial phase 1 trial of patients treated with focal transrectal MRI-guided focused ultrasound in North America. SUBJECTS AND METHODS: Four patients with a prostate-specific antigen (PSA) level of 10 ng/mL or less, tumor classification cT2a or less, and a Gleason score of 6 (3 + 3) were prospectively enrolled in the study and underwent multiparametric MRI and transrectal ultrasound-guided prostate systematic biopsy. Under MRI guidance and real-time monitoring with MR thermography, focused high-frequency ultrasound energy was delivered to ablate the target tissue. The incidence and severity of treatment-related adverse events were recorded along with responses to serial quality-of-life questionnaires for 6 months after treatment. Oncologic outcomes were evaluated with multiparametric MRI and repeat transrectal ultrasound-guided biopsy 6 months after treatment. RESULTS: Four patients with a total of six target lesions were treated and had complications graded Clavien-Dindo I or less. Quality-of-life parameters were similar between baseline and 6-months. All four patients had normal MRI findings in the treated regions (100%), biopsy showed that three patients (75%) were clear of disease in the treated regions, representing complete ablation of five target lesions (83%). All patients had at least one Gleason 6-positive core outside of the treated zone. CONCLUSION: MRI-guided focused ultrasound is a feasible method of noninvasively ablating low-risk prostate cancers with low morbidity. Further investigation and follow-up are warranted in a larger patient series with appropriate statistical analysis of oncologic and functional outcome measures.
