Vascular-Targeted Photodynamic Therapy Using WST 11 in Patients With Localized Prostate Cancer
This trial is designed as a multicentre, phase II, open-labeled, single intra-venous (IV)
dose study. The patient is to receive general anesthesia. WST11-mediated VTP will consist of
the combination of a single IV administration of WST11 at doses of 2 mg/Kg,4mg/Kg and 6
mg/kg, using 753 nm laser light at a fixed power (150mW/cm) and energy (200 J/cm) delivered
through transperineal interstitial optical fibers. If deemed necessary and in consideration
of the results of the patients treated with 200 J/cm, alternate power (200mW/cm) and
alternate energy (300 J/cm) might be applied after Sponsor, Steering Committee and DSMB
approval.The fibers are introduced into transparent needles that are positioned in the
prostate under ultra sound image guidance (using a brachytherapy like template). The tumor
location is established using transrectal biopsy and MR imaging. The number of fibers and
the total light energy will be adapted to each patient, taking into account the tumor
localization and the volume of the prostate.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Negative biopsy in the treated lobe
Month 6
No
Mark EMBERTON, Professor
Principal Investigator
Urology Directorate
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
CLIN801 PCM201
NCT00707356
September 2008
July 2012
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