Phase II/III Study of WST09 in Prostate Cancer After Radiation Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00312442|
Recruitment Status : Terminated (STEBA decided to develop WST11 that is soluble in aqueous solutions. The property of WST 11 make it safer and better candidate for therapeutic applications.)
First Posted : April 10, 2006
Last Update Posted : June 2, 2010
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Treatment with WST09 Vascular Photodynamic therapy||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Photodynamic Therapy With WST09 in Patients With Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||December 2009|
Experimental: WST 09
Treatment with WST09-mediated VTP
|Drug: Treatment with WST09 Vascular Photodynamic therapy|
- Prostate biopsy results at Month 6 after treatment. [ Time Frame: 6 months ]
- Percentage of positive cores in the biopsies prior to and 6 months after the WST09-mediated VTP. [ Time Frame: 6 months ]
- PSA levels taken periodically for 1 year after the procedure [ Time Frame: Month 1,3,6 and 1 year ]
- Hypoperfusion according to MRI at Week 1 after the procedure. [ Time Frame: 1 week and Month 6 ]
- Calculated PSA velocity before and after WST09-mediated VTP. [ Time Frame: Month 1,3,6 and 1 year ]
- 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 ]
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312442
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||John Trachtenberg, MD FRCS(C)||University Health Network, Princess Margaret Hospital|