Study of WST09 in Prostate Cancer After Radiation: Repeat Procedure

STEBA France

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: Treatment with Tookad VTP

Study type

Interventional

Funder types

Industry

Identifiers

NCT00305929

HEC/WST041251N/WST2.18

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 estimated patients

Sex

Male

Volunteers

No 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