Journal article
TOOKAD((R)) Soluble vascular-targeted photodynamic (VTP) therapy: determination of optimal treatment conditions and assessment of effects in patients with localised prostate cancer
BJU International, Vol.112(6), pp.766-774
Oct/2013
Abstract
Objectives To evaluate the optimal treatment conditions and effects of TOOKAD((R)) Soluble vascular-targeted photodynamic (VTP) therapy in patients with localised prostate cancer. To evaluate the safety and quality of life after TOOKAD((R)) Soluble VTP treatment in patients with localised prostate cancer. Patients and Methods Men (aged > 18 years) diagnosed with localised prostate cancer, who were suitable for active surveillance, were invited to take part in the study. Patients who had received prior or current treatment for their cancer were excluded. There were two parts to the study: in part one, patients were assigned to one of two treatment groups based on the size of their prostates (patients with prostate size <60 mL would receive 4 mg/kg TOOKAD((R)) Soluble and patients with prostate size >= 60 mL would receive 6 mg/kg TOOKAD((R)) Soluble both activated with 200 J/cm light). In part two, patients were assigned to one of two treatment groups based on predefined criteria and received either 4 or 6 mg/kg TOOKAD((R)) Soluble and 200 or 300 J/cm light. VTP was conducted under general anaesthesia using TOOKAD((R)) Soluble administered intravenously and activated by light-diffusing fibres within the prostate via the perineum. Follow-up was conducted for 6 months. Magnetic resonance imaging (MRI) carried out at 1 week after VTP and transrectal prostate biopsy at 6 months were the key endpoints. Adverse event (AE) recording and patient-reported outcome measures were collected. Results In all, 86 patients were enrolled in the study and 85 patients received treatment. Of the 85 treated patients, one patient discontinued (due to withdrawal of consent). At 6 months, 61/83 (74%) patients who underwent prostate biopsy had histopathology that was negative for prostate cancer (95% confidence interval (CI) 62.7-82.6%). Considering patients who received 4 mg/kg TOOKAD((R)) Soluble and 200 J/cm light (unilateral), which are considered optimal treatment parameters, 38/46 (8
Details
- Title
- TOOKAD((R)) Soluble vascular-targeted photodynamic (VTP) therapy; determination of optimal treatment conditions and assessment of effects in patients with localised prostate cancer
- Creators
- Abdel-Rahmene Azzouzi (null)Eric Barret (null)Caroline M. Moore (null)Arnaud Villers (null)Clare Allen (null)Avigdor Scherz (null) - 972WIS_INST___110Gordon Muir (null)Wildt, Michel de Wildt (null)Neil J. Barber (null)Souhil Lebdai (null)Mark Emberton (null)
- Resource Type
- Journal article
- Publication Details
- BJU International, Vol.112(6), pp.766-774; Oct/2013
- Number of pages
- 9
- Language
- English
- DOI
- https://doi.org/10.1111/bju.12265
- Record Identifier
- 993265398103596
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