Focal Laser Ablation of XXXX : Phase I Clinical Trial.

@entity1 @entity263 @entity39 @entity5 @entity1486
PURPOSE: Focal laser ablation is an investigational technique to treat @entity263 in a region confined manner via @entity39 . This phase I trial primarily examines the safety of transrectal magnetic resonance imaging guided (in-bore) focal laser ablation in @entity1 with intermediate @entity263 . An exploratory end point is @entity5 control after 6 months. MATERIALS AND METHODS: In an institutional review board approved trial we studied focal laser ablation in 8 @entity1 with intermediate @entity263 diagnosed using magnetic resonance-ultrasound fusion. Focal laser ablation was performed by inserting a cylindrically diffusing, water cooled laser fiber into magnetic resonance visible regions of interest, followed by interstitial heating at 10 to 15 W for up to 3 minutes. Secondary safety monitors (thermal probes) were inserted to assess the accuracy of magnetic resonance thermometry. Comprehensive magnetic resonance-ultrasound fusion biopsy was performed after 6  months. Adverse events and health related quality of life questionnaires were recorded. RESULTS: Focal laser ablation was successfully performed in all 8 subjects. No grade 3 or greater adverse events occurred and no changes in International Prostate Symptom Score or International Index of Erectile Function 5 were observed. Ablation zones, as measured by posttreatment magnetic resonance imaging, had a median volume of 3 cc or 7.7% of prostate volume. @entity1486 decreased in 7 @entity1 (p <0.01). At followup magnetic resonance-ultrasound fusion biopsy @entity5 was not detected in the ablation zone in 5 @entity1 but was present outside the treatment margin in 6 @entity1 . CONCLUSIONS: Focal laser ablation of the prostate is feasible and safe in @entity1 with intermediate @entity263 , without serious adverse events or changes in urinary or sexual function at 6 months. Comprehensive biopsy followup indicates that larger treatment margins than previously thought necessary may be required for complete @entity5 ablation.
