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Brief Title: Study Using WST11 in Patients With Localized Prostate Cancer
Official Title: Vascular-Targeted Photodynamic Therapy Using WST11 in Patients With Localized Prostate Cancer
Study ID: NCT00975429
Brief Summary: The aim of this trial is to determine the optimal treatment conditions to achieve prostate cancer tumour ablation and to assess the effects of WST11-mediated Vascular-Targeted Photodynamic therapy (VTP) treatment in patients with localized prostate cancer. The secondary objectives are to assess the safety and quality of life following WST11-mediated VTP treatment,to assess the effects,safety and quality of life following a second WST11-mediated VTP treatment; and to explore optimisation techniques to reduce the duration of the VTP procedure.
Detailed Description: This trial is designed as a multicentre, phase II, open-labeled, multi-arm, single intravenous (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 4 or 6 mg/kg using 753nm laser light at a fixed power (150 mW/cm or 200 mW/cm or 250 mW/cm ) and light energy (200 J/cm or 300J/cm) delivered through transperineal interstitial optical fibers. The fibers are introduced into transparent needles that are positioned in the prostate under ultra sound guidance. The tumour location is established using transrectal biopsy and MR imaging. The number of fibers and the total light energy will be adapted to each patient based on a treatment planning proposed by treatment planning group.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Centre Hospitalier Universitaire (CHU), Angers, , France
Hôpital Claude Huriez, Lille, , France
Institut Mutualiste Montsouris(IMM), Paris, , France
Catharina Ziekenhuis, Eindhoven, , Netherlands
Frimley Park Hospital NHS Trust, Frimley, , United Kingdom
Kings College Hospital (KCH), London, , United Kingdom
University College London Hospital (UCLH), London, , United Kingdom
Name: Mark Emberton, Professor
Affiliation: University College London Hospital (UCLH)
Role: PRINCIPAL_INVESTIGATOR
Name: Gordon MUIR, MD
Affiliation: Kings College Hospital (KCH)
Role: PRINCIPAL_INVESTIGATOR
Name: Neil BARBER, MD
Affiliation: Frimley Park Hospital NHS Trust
Role: PRINCIPAL_INVESTIGATOR
Name: Michel de Wildt, MD
Affiliation: Catharina Ziekenhuis
Role: PRINCIPAL_INVESTIGATOR
Name: Abdel-Rahmène AZZOUZI, Professor
Affiliation: Centre Hospitalier Unniversitaire Angers(CHU)
Role: PRINCIPAL_INVESTIGATOR
Name: Eric BARRET, MD
Affiliation: Institut Mutualiste Montsouris (IMM)
Role: PRINCIPAL_INVESTIGATOR
Name: Arnauld VILLERS, Professor
Affiliation: Hôpital Claude-Huriez
Role: PRINCIPAL_INVESTIGATOR