Phase II/III Study of WST09 in Prostate Cancer After Radiation Therapy
The aim of this clinical trial is to evaluate the efficacy and safety of the WST09-mediated vascular-targeted photodynamic therapy (VTP) in patients with localized prostate cancer recurrent after external radiation therapy or temporary (High Dose Rate, or HDR) brachytherapy.
Drug: Treatment with WST09 Vascular Photodynamic therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study of Photodynamic Therapy With WST09 in Patients With Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy|
- Prostate biopsy results at Month 6 after treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Percentage of positive cores in the biopsies prior to and 6 months after the WST09-mediated VTP. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- PSA levels taken periodically for 1 year after the procedure [ Time Frame: Month 1,3,6 and 1 year ] [ Designated as safety issue: No ]
- Hypoperfusion according to MRI at Week 1 after the procedure. [ Time Frame: 1 week and Month 6 ] [ Designated as safety issue: No ]
- Calculated PSA velocity before and after WST09-mediated VTP. [ Time Frame: Month 1,3,6 and 1 year ] [ Designated as safety issue: No ]
- Nadir of the PSA after the WST09-mediated VTP compared with the nadir of PSA after radiation therapy [ Time Frame: Month 1,3,6 and 1 year ] [ Designated as safety issue: No ]
- To assess the safety and tolerability of WST09-mediated VTP treatment in this patient population [ Time Frame: Day1,Day 7, Month1,3,6,and 12 ] [ Designated as safety issue: Yes ]The evaluation of safety will be based on reported adverse events, changes in vital signs and laboratory tests from the Treatment Visit until the study is completed.
|Study Start Date:||May 2006|
|Study Completion Date:||December 2009|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Experimental: WST 09
Treatment with WST09-mediated VTP
|Drug: Treatment with WST09 Vascular Photodynamic 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.
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||John Trachtenberg, MD FRCS(C)||University Health Network, Princess Margaret Hospital|