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Spots Global Cancer Trial Database for Study Using WST11 in Patients With Localized Prostate Cancer

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Trial Identification

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

Conditions

Prostate Cancer

Interventions

WST11
WST11

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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