TOOKAD(  ) Soluble focal therapy: pooled analysis of three phase II studies assessing the minimally invasive ablation of XXXX .

@entity1 @entity263
PURPOSE: To evaluate the 6-month effects of the recommended drug and light dosage in focal vascular-targeted photodynamic therapy (VTP) using TOOKAD(  ) Soluble in @entity1 with @entity263 ( @entity263 ). METHODS: We performed a pooled analysis of 117 @entity1 with @entity263 , PSA <10  ng/mL, and Gleason score  <=7 (3  +  4), from 3 studies who received a 10-min intravenous infusion of a single dose of 4  mg/kg TOOKAD(  ) Soluble, activated by a 753-nm light at 200  J/cm delivered in the prostate by transperineal fibres under transrectal ultrasound guidance. Primary endpoint was 6-month negative biopsies in the treated lobe(s). PSA was measured at month 1, 3, and 6. Magnetic resonance imaging was performed at day 7, month 3, and 6. International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF-5) and adverse events were reported at day 7, month 1, 3, and 6. RESULTS: Month 6 negative biopsy rate was 68.4  % in the overall evaluable population (N  =  114) and 80.6  % for @entity1 treated by hemiablation with light density index (LDI)  >=   1 (N  =  67). Mean prostate necroses at week-1 were 76.5 and 86.3  %, respectively. In both groups, PSA levels at month 6 decreased by 2.0  ng/mL. Small changes from baseline for IPSS and IIEF-5 indicated a slight improvement in urinary function and a slight deterioration in sexual function. CONCLUSIONS: Focal VTP treatment with TOOKAD(  ) Soluble at 4  mg/kg and 200  J/cm resulted in a negative 6-month biopsy rate of 68.4  % for the whole population and 80.6  % for @entity1 treated by hemiablation with LDI  >=   1. The treatment was well tolerated. Two phase III studies will reach completion in early 2015.
