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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014