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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
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.
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.
Centre Hospitalier Universitaire (CHU)
Angers, France
Hôpital Claude Huriez
Lille, France
Institut Mutualiste Montsouris(IMM)
Paris, France
Catharina Ziekenhuis
Eindhoven, Netherlands
Negative biopsy in the treated lobes
Time frame: Month 6
Serum PSA levels and PSA changes after treatment compared to baseline.
Time frame: Month 1, Month 3 & Month 6
Volume of hypoperfusion area shown by dynamic gadolinium MRI.
Time frame: Day 7, Month 6
Adverse events, ECG (12-lead),vital signs,clinical laboratory evaluations, physical examination.
Time frame: Screening-Month 6
Quality of life IPSS; IIEF
Time frame: Month 1, Month 3 & Month 6
Optimisation of the procedure
Time frame: Day 1
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Frimley Park Hospital NHS Trust
Frimley, United Kingdom
Kings College Hospital (KCH)
London, United Kingdom
University College London Hospital (UCLH)
London, United Kingdom