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Study Using WST11 in Patients With Localized Prostate Cancer

NCT00975429 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2015-04-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

WST11

The WST11-mediated VTP procedure will consist of a single IV administration of WST11 at a dose of 4mg/kg using a 753nm laser light at a fixed power (150mW/cm or 200mW/cm or 250mW/cm) and light energy (200J/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 image 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.

DRUG

WST11

The WST11-mediated VTP procedure will consist of a single IV administration of WST11 at a dose of 6mg/kg in patients using a 753nm laser light at a fixed power (150mW/cm or 200mW/cm or 250mW/cm ) and light energy (200J/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 image 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.

Sponsors & Collaborators

  • Steba Biotech S.A.

    lead OTHER

Principal Investigators

  • Mark Emberton, Professor · University College London Hospital (UCLH)

  • Gordon MUIR, MD · Kings College Hospital (KCH)

  • Neil BARBER, MD · Frimley Park Hospital NHS Trust

  • Michel de Wildt, MD · Catharina Ziekenhuis

  • Abdel-Rahmène AZZOUZI, Professor · Centre Hospitalier Unniversitaire Angers(CHU)

  • Eric BARRET, MD · Institut Mutualiste Montsouris (IMM)

  • Arnauld VILLERS, Professor · Hôpital Claude-Huriez

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-12-31
Completion
2012-08-31

Countries

  • France
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00975429 on ClinicalTrials.gov