Study of WST09 in Prostate Cancer After Radiation: Repeat Procedure
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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 |
- Prostate biopsy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 |
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| Canada, Ontario | |
| The Prostate Centre Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| 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 May 23, 2013