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| Sponsor: | Steba Biotech S.A. |
|---|---|
| Information provided by: | Steba Biotech S.A. |
| ClinicalTrials.gov Identifier: | NCT00707356 |
Purpose
The aim of this clinical is to determine the optimal treatment conditions to achieve prostate cancer tumor ablation and to assess the effects of WST11 mediated VTP treatment in patients with localized prostate cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Localized Prostate Cancer |
Drug: WST11 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | PHASE II Vascular-Targeted Photodynamic Therapy Using WST 11 in Patients With Localized Prostate Cancer |
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
WST11: Experimental
Treatment with WST11-mediated VTP
|
Drug: WST11
WST11-mediated VTP will consist of the combination of a single IV administration of WST11 at doses of 2 to 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.The fibers are introduced into transparent needles that are positioned in the prostate under ultra sound image guidance. 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.
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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 to 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United Kingdom | |
| Urology Directorate | Recruiting |
| London, United Kingdom | |
| Contact: Mark EMBERTON, Professor + 44-20-7380-9194 markemberton@btinternet.com | |
| Principal Investigator: Mark EMBERTON, Professor | |
| Principal Investigator: | Mark EMBERTON, Professor | Urology Directorate |
More Information
| Responsible Party: | STEBABIOTECH S.A ( Daniel ELKOUBI ) |
| Study ID Numbers: | CLIN801 PCM201 |
| Study First Received: | June 26, 2008 |
| Last Updated: | September 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00707356 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency; Canada: Health Canada; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
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Prostatic disease genital neoplasm, male Urogenital neoplasm Genital disease male |
Male urogenital disease Neoplasms Neoplasm by site prostatic neoplasm Carcinoma |
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Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |