- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00305929
Study of WST09 in Prostate Cancer After Radiation: Repeat Procedure
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- The Prostate Centre Princess Margaret Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Treatment with Tookad VTP
|
Other Names:
Tookad 2 mg/kg
2 mg/kg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prostate biopsy
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MRI, PSA
Time Frame: 7 days, 6 months
|
7 days, 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John Trachtenberg, MD, FRCS(C), University Health Network, Princess Margaret Hospital
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEC/WST041251N/WST2.18
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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