A Prospective, Multicenter Phase I/II Safety and Tolerability Study of Unilateral Vascular-Targeted Photodynamic Therapy Using WST11 in Patients With Localized Prostate Cancer
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
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
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
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To define the study drug and light dosage combination to achieve negative biopsy in the treated lobe.
Samir Taneja, Professor
Department of Urology, New York University Cancer Institute
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|NYU Urology Associates||New York, New York 10016|
|UCLA - Jonsson Comprehensive Cancer Center||Los Angeles, California 90095|
|Midtown Urology & Midtown Urology Surgical Center||Atlanta, Georgia 30308|
|Washington University School of Medicine- Barnes-Jewish Hospital||St. Louis, Missouri 63110|