Phase II Study of Photodynamic Therapy With WST09 in Patients With Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure - Repeat Procedure
N/A
N/A
Male
Prostate Cancer
Trial Information
Phase II Study of Photodynamic Therapy With WST09 in Patients With Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure - Repeat Procedure
Multi-centre, phase II, open-label, 12-month clinical trial for patients that previously
received a vascular-targeted photodynamic treatment (VTP) with WST09 (Tookad) and still have
histological findings (prostate biopsies) indicating the presence of localized cancer.
The WST09-mediated VTP procedure consists of an I.V. infusion of WST09 (Tookad) at 2 mg/kg,
in combination with the per-cutaneous interstitial delivery of monochromatic laser light (of
a wavelength of 763nm) via the trans-perineal implantation of illumination fibres,
positioned in the prostatic lobes.
In a previous Tookad trial, escalating doses of laser light were used with a fixed dose of
WST09 (2 mg/kg) in patients with localized prostatic cancer. Patients who underwent the
procedure but still have positive prostate biopsies (residual cancer) may benefit from an
additional WTS09-mediated VTP procedure. Thus, the aim of this study is to treat patients
still presenting with localized prostate cancer with a second WST09-mediated VTP procedure.
Inclusion Criteria:
- Patients previously treated with WST09-mediated VTP, with a positive biopsy of the
prostate 6 months following treatment
- Disease confined to the prostate
- Life expectancy greater than 5 years
Exclusion Criteria:
- Unwilling or unable to give informed consent
- Patients who have received another treatment for their prostate cancer since their
previous WST09-mediated VTP
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Prostate biopsy
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
John Trachtenberg, MD, FRCS(C)
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Health Network, Princess Margaret Hospital
Authority:
Canada: Health Canada
Study ID:
HEC/WST041251N/WST2.18
NCT ID:
NCT00305929
Start Date:
March 2006
Completion Date:
December 2007
Related Keywords:
- Prostate Cancer
- Treatment of localized prostate cancer
- Localized prostate cancer
- Prostatic Neoplasms
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