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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00305929

Enrollment

Registered

2006-03-22

Start date

2006-03-31

Completion date

2007-12-31

Last updated

2010-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Treatment of localized prostate cancer, Localized prostate cancer

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.

Interventions

DRUGTreatment with Tookad VTP

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Prostate biopsy	12 months

Secondary

Measure	Time frame
MRI, PSA	7 days, 6 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026