Study of Photodynamic Therapy With WST09 in Patients With Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy
This is a multicentre, open labelled, phase II/III, 6-month clinical trial with an
additional follow-up at Month 12, aiming to determine the efficacy and tolerability of the
WST09-mediated VTP treatment. This treatment consists of an I.V. infusion of WST09 (2
mg/kg), in combination with per-cutaneous interstitial illumination using laser light
(wavelength at 763nm) delivered through optical fibres positioned through the perineum in
the prostatic lobes.
Patients who are eligible to participate in the study must have a clinically diagnosed
positive biopsy of the prostate (up to stage T2b-N0-M0) diagnosed after external
radiotherapy or temporary brachytherapy (no seeds), and present with increasing PSA levels
on three consecutive occasions (at least 3 months apart) post-radiation treatment.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Prostate biopsy results at Month 6 after treatment.
John Trachtenberg, MD FRCS(C)
University Health Network, Princess Margaret Hospital
Canada: Health Canada
HEC/WST0512 66N/WST 2.21