title: TOOKAD® Soluble focal therapy: pooled analysis of three phase II studies assessing the minimally invasive ablation of localized prostate cancer.
abstract: OBJECTIVE
  To evaluate the 6-month effects of the recommended drug and light dosage in focal vascular-targeted photodynamic therapy (VTP) using TOOKAD(®) Soluble in patients with localized prostate cancer (LPCa).
  
  
  METHODS
  We performed a pooled analysis of 117 men with LPCa, 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 patients 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 patients treated by hemiablation with LDI ≥ 1. The treatment was well tolerated. Two phase III studies will reach completion in early 2015.
authors.affiliation: Urology Department, University Hospital, CHU Angers, 4 rue Larrey, 49933, Angers Cedex 9, France, arazzouzi@chu-angers.fr.
authors.forename: A R
authors.initials: AR
authors.lastname: Azzouzi
authors.forename: E
authors.initials: E
authors.lastname: Barret
authors.forename: J
authors.initials: J
authors.lastname: Bennet
authors.forename: C
authors.initials: C
authors.lastname: Moore
authors.forename: S
authors.initials: S
authors.lastname: Taneja
authors.forename: G
authors.initials: G
authors.lastname: Muir
authors.forename: A
authors.initials: A
authors.lastname: Villers
authors.forename: J
authors.initials: J
authors.lastname: Coleman
authors.forename: C
authors.initials: C
authors.lastname: Allen
authors.forename: A
authors.initials: A
authors.lastname: Scherz
authors.forename: M
authors.initials: M
authors.lastname: Emberton
mesh_terms: D001429:Bacteriochlorophylls / Q000627:therapeutic use*; D017322:Clinical Trials, Phase II as Topic; D006801:Humans; D008297:Male; D010778:Photochemotherapy / Q000379:methods*; D017319:Photosensitizing Agents / Q000627:therapeutic use*; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D001429:Bacteriochlorophylls; D017319:Photosensitizing Agents; C456120:palladium-bacteriopheophorbide