Study of WST09 in Prostate Cancer After Radiation: Repeat Procedure

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. Identifier: NCT00305929
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : June 2, 2010
Information provided by:
STEBA France

Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Drug: Treatment with Tookad VTP Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2006
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Prostate biopsy [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. MRI, PSA [ Time Frame: 7 days, 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00305929

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

Responsible Party: STEBA France Identifier: NCT00305929     History of Changes
Other Study ID Numbers: HEC/WST041251N/WST2.18
First Posted: March 22, 2006    Key Record Dates
Last Update Posted: June 2, 2010
Last Verified: May 2010

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
Genital Diseases, Male
Prostatic Diseases