Study of WST09 in Prostate Cancer After Radiation: Repeat Procedure
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|ClinicalTrials.gov Identifier: NCT00305929|
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : June 2, 2010
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|
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Treatment with Tookad VTP
Drug: Treatment with Tookad VTP
Other Name: WST09Drug: Treatment with Tookad VTP
Tookad 2 mg/kgDrug: Treatment with Tookad VTP
- Prostate biopsy [ Time Frame: 12 months ]
- MRI, PSA [ Time Frame: 7 days, 6 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT00305929
|The Prostate Centre Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||John Trachtenberg, MD, FRCS(C)||University Health Network, Princess Margaret Hospital|