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| Sponsor: | Steba Biotech S.A. |
|---|---|
| Information provided by (Responsible Party): | Steba Biotech S.A. |
| ClinicalTrials.gov Identifier: | NCT00707356 |
Purpose
The aim of this clinical study 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.
The secondary objectives is to evaluate safety and quality of life and to assess the effects of a second WST11 VTP treatment in patients with persistent or recurrent localized prostate cancer after a first VTP
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: WST11 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Vascular-Targeted Photodynamic Therapy Using WST 11 in Patients With Localized Prostate Cancer |
| Enrollment: | 40 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | February 2012 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: WST11
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 mg/Kg,4 mg/Kgand6 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 or transperineal 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.
Other Name: WST11-mediated VTP
|
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 mg/Kg,4mg/Kg and 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
More Information
| Responsible Party: | Steba Biotech S.A. |
| ClinicalTrials.gov Identifier: | NCT00707356 History of Changes |
| Other Study ID Numbers: | CLIN801 PCM201 |
| Study First Received: | June 26, 2008 |
| Last Updated: | January 2, 2012 |
| 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 |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |