Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305929
Status:
COMPLETED
Last Update Posted:
2010-06-02
First Post:
2006-03-20
Brief Title:
Study of WST09 in Prostate Cancer After Radiation Repeat Procedure
Sponsor:
STEBA France
Organization:
STEBA France
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
The study aims at delivering a second WST09 treatment for the purpose of eradicating the localized prostate cancer
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 IV infusion of WST09 Tookad at 2 mgkg 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 mgkg 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
The WST09-mediated VTP procedure consists of an IV infusion of WST09 Tookad at 2 mgkg 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 mgkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None