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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: STEBA France · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Treatment with Tookad VTP
DRUG	Treatment with Tookad VTP	Tookad 2 mg/kg
DRUG	Treatment with Tookad VTP	2 mg/kg

Timeline

• Start date: 2006-03-01
• Completion: 2007-12-01
• First posted: 2006-03-22
• Last updated: 2010-06-02

Locations

1 site across 1 country: Canada