Study of WST09 in Prostate Cancer After Radiation: Repeat Procedure

Study Overview
=================
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.

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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Treatment with Tookad VTP
* Drug: Treatment with Tookad VTP
* Drug: Treatment with Tookad VTP


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Treatment with Tookad VTP | Drug: Treatment with Tookad VTP<br> <br> * Other names: WST09;Drug: Treatment with Tookad VTP<br>* Tookad 2 mg/kg<br>Drug: Treatment with Tookad VTP<br>* 2 mg/kg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate biopsy |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI, PSA |  | 7 days, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment of localized prostate cancer, Localized prostate cancer