Safety and Tolerability Study Using WST11 In Patients With Localized Prostate Cancer
The aim of this study is to determine the optimal treatment conditions (WST11 dose and light energy dose) to achieve ablation in one lobe of the prostate and to evaluate the safety and quality of life of WST11 medicated Vascular-Targeted Photodynamic therapy (VTP) in men with localized prostate cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Multicenter Phase I/II Safety and Tolerability Study of Unilateral Vascular-Targeted Photodynamic Therapy Using WST11 in Patients With Localized Prostate Cancer|
- To define the study drug and light dosage combination to achieve negative biopsy in the treated lobe. [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]
- To determine the safety and tolerability effects, including toxicity, of WST11-mediated VTP treatment in patients with localized prostate cancer [ Time Frame: Day 1, Day 2, Day 4, Week 1, Month 1,Month 3,Month 6, Month 12 ] [ Designated as safety issue: Yes ]
- To evaluate the quality of life following WST11 VTP treatment in patients with localized prostate cancer [ Time Frame: Month 1, Month 3 , Month 6 , Month 12 ] [ Designated as safety issue: No ]
- To assess the pharmacokinetic parameters of WST-11 infusion, using serum and urine analysis [ Time Frame: Day 1, Day 2,Day 4 ] [ Designated as safety issue: No ]
- To assess the pharmacodynamics (the VTP effects) [ Time Frame: Week 1, Month 6, Month 12 ] [ Designated as safety issue: No ]
- To evaluate the volume of necrosis observed on the 7-Day MRI and correlate this observed necrosis with the biopsy outcome at Month 6. [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
- To assess the safety and efficacy of a second WST11 VTP treatment in patients with persistent or recurrent localized prostate cancer. [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2009|
|Study Completion Date:||August 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: WST 11(TOOKAD® Soluble)
Drug: WST 11 -mediated -VTP
The WST11-mediated VTP procedure will consist of a single, 10 min, IV administration of WST11 at doses of either 2mg/kg, 4 mg/kg or 6 mg/kg, followed by light activation delivered through one or more transperineal interstitial optical fibers for 20 minutes using 753 nm laser light at escalating fixed energy doses of 200 J/cm and 300 J/cm, by escalating power at each energy to 167 mW/cm and 250 mW/cm, respectively. A brachytherapy-like template is used for the placement of the optical fiber(s) that are positioned in the prostate areas of interest under trans-rectal ultrasound image guidance.
This study is designed as a multicenter, phase I/II, prospective, open-labeled, single intravenous (IV) dose, clinical trial in patients with localized prostate cancer.
The study population will be men who have been offered curative therapy (radical prostatectomy; cryotherapy; brachytherapy; EBRT), and refused. Patients must have already had a previous biopsy showing a histologically proven carcinoma of the prostate. The identification and the location of the tumor will be done using both dynamic contrast MRI and biopsy.
Only unilateral treatment with WST11-medicated VTP will be performed during the study. Treatment will consist of a single, 10 minute, IV administration of WST11 at doses of 2mg/kg, 4 mg/kg or 6 mg/kg, followed by either light activation delivered through transperineal interstitial optical fibers for 20 minutes using 753 nm laser light at escalating fixed energy doses of 200 J/cm or 300 J/cm by escalating power at each energy to 167 mW/cm or 250 mW/cm respectively. A brachytherapy-like template is used for the placement of the transparent implant catheters which are positioned in the prostate under transrectal ultrasound image guidance. The illumination fiber(s) are then inserted into the implant catheters.
If the safety profile for a given WST11 and light dose is acceptable, additional patients (up to 3) may be treated with multiple fibers at that WST11 treatment dose.
For cases where the Month 6 biopsy is positive, the patient will be offered the opportunity to be retreated with WST11
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946881
|United States, California|
|UCLA - Jonsson Comprehensive Cancer Center|
|Los Angeles, California, United States, 90095|
|United States, Georgia|
|Midtown Urology & Midtown Urology Surgical Center|
|Atlanta, Georgia, United States, 30308|
|United States, Missouri|
|Washington University School of Medicine- Barnes-Jewish Hospital|
|St. Louis, Missouri, United States, 63110|
|United States, New York|
|NYU Urology Associates|
|New York, New York, United States, 10016|
|Memorial Sloan-Kettering Cancer Center|
|New York,, New York, United States, 10021|
|Principal Investigator:||Samir Taneja, Professor||Department of Urology, New York University Cancer Institute|