Study of WST09 in Prostate Cancer After Radiation: Repeat Procedure

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Treatment with Tookad VTP

• Registration Number: NCT00305929
• Lead Sponsor: STEBA France

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.

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 Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-20
• Study First Submitted QC: 2006-03-20
• Study First Posted: 2006-03-22
• Study Completion: 2007-12
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-31
• Last Update Posted: 2010-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Treatment with Tookad VTP	Treatment with Tookad VTP

Primary Outcome Measures

Name	Time	Method
Prostate biopsy	12 months

Secondary Outcome Measures

Name	Time	Method
MRI, PSA	7 days, 6 months

Trial Locations

Locations (1)

The Prostate Centre Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada