Safety and Tolerability Study Using WST11 In Patients With Localized Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00946881|
Recruitment Status : Completed
First Posted : July 27, 2009
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: WST 11 -mediated -VTP||Phase 1 Phase 2|
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; External Beam RadioTherapy (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 Magnetic resonance Imaging (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 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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||August 2012|
Experimental: WST11 (TOOKAD® Soluble)
WST11-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 using 753 nm laser light at escalating fixed energy doses
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.
Other Name: TOOKAD Soluble
- Prostate Biopsy [ Time Frame: Month 6 ]
WST 11(TOOKAD® Soluble) Arm/Group Description To define the study drug and light dosage combination to achieve negative biopsy in the treated lobe
- Prostate Biopsies [ Time Frame: Month-6 ]Number of patients who had a negative biopsy at Month-6
- Pharmacokinetic Parameters-Cmax [ Time Frame: T0, 5 min,10 min, 4 h, 8 h, post dose ]For each dose group, several pharmacokinetics parameters have been calculated.
- Percentage of Prostatic Necrosis at Day 7 as Observed on the 7-Day MRI [ Time Frame: Day 7 ]
The adjusted prostate necrosis percentage was defined as follows:
The Day 7 necrosis percentage is the proportion, expressed in %, of Day 7 prostate necrosis volume by planimetry in the treated lobe compared with half the prostate volume by planimetry, considering the average between the baseline volume and Day 7 volume;
- International Index of Erectile Functions (IIEF) Results [ Time Frame: Month 1-Month 3- Month 6- Month 12 ]The International Index of Erectile Functions questionnaire is 15 questions patients auto questionnaire. The results presented are those of the erectile function domain which comprise 6 questions. Possible scores range is 1 to 30 . Best score is 30, worst score is 1.
- International Prostate Symptom Score (IPSS) Results [ Time Frame: Month 1, Month 3 , Month 6 , Month 12 ]The International Prostate Symptom Score (IPSS) is a 7 questions patients auto-questionnaire about urinary symptoms. the possible scores range are 0 to 35 . Best score is 0 worst score is 35
- Pharmacokinetic Parameters-Tmax [ Time Frame: T0, 5 min,10 min, 4 h, 8 h, post dose ]For each dose group, several pharmacokinetics parameters have been calculated.
- Pharmacokinetic Parameters -T1/2 [ Time Frame: T0, 5 min,10 min, 4 h, 8 h, post dose ]For each dose group, several pharmacokinetics parameters have been calculated.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Saint 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|