Study of WST09 in Prostate Cancer After Radiation: Repeat Procedure

This study has been completed.
Sponsor:
Information provided by:
STEBA France
ClinicalTrials.gov Identifier:
NCT00305929
First received: March 20, 2006
Last updated: May 31, 2010
Last verified: May 2010
  Purpose

This is a multi-centre, phase II, open-label, 12-month clinical trial for patients previously treated with WST09 (Tookad) who have positive prostate biopsies for cancer.

The study aims at delivering a second WST09 treatment for the purpose of eradicating the localized prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: Treatment with Tookad VTP
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by STEBA France:

Primary Outcome Measures:
  • Prostate biopsy [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MRI, PSA [ Time Frame: 7 days, 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8
Study Start Date: March 2006
Study Completion Date: December 2007
Arms Assigned Interventions
Experimental: 1
Treatment with Tookad VTP
Drug: Treatment with Tookad VTP
Other Name: WST09
Drug: Treatment with Tookad VTP
Tookad 2 mg/kg
Drug: Treatment with Tookad VTP
2 mg/kg

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305929

Locations
Canada, Ontario
The Prostate Centre Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
STEBA France
Investigators
Principal Investigator: John Trachtenberg, MD, FRCS(C) University Health Network, Princess Margaret Hospital
  More Information

No publications provided

Responsible Party: STEBA France
ClinicalTrials.gov Identifier: NCT00305929     History of Changes
Other Study ID Numbers: HEC/WST041251N/WST2.18
Study First Received: March 20, 2006
Last Updated: May 31, 2010
Health Authority: Canada: Health Canada

Keywords provided by STEBA France:
Treatment of localized prostate cancer
Localized prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014