Phase II/III Study of WST09 in Prostate Cancer After Radiation Therapy

Study of Photodynamic Therapy With WST09 in Patients With Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy

The aim of this clinical trial is to evaluate the efficacy and safety of the WST09-mediated vascular-targeted photodynamic therapy (VTP) in patients with localized prostate cancer recurrent after external radiation therapy or temporary (High Dose Rate, or HDR) brachytherapy.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Treatment with WST09 Vascular Photodynamic therapy

Detailed Description

This is a multicentre, open labelled, phase II/III, 6-month clinical trial with an additional follow-up at Month 12, aiming to determine the efficacy and tolerability of the WST09-mediated VTP treatment. This treatment consists of an I.V. infusion of WST09 (2 mg/kg), in combination with per-cutaneous interstitial illumination using laser light (wavelength at 763nm) delivered through optical fibres positioned through the perineum in the prostatic lobes.

Patients who are eligible to participate in the study must have a clinically diagnosed positive biopsy of the prostate (up to stage T2b-N0-M0) diagnosed after external radiotherapy or temporary brachytherapy (no seeds), and present with increasing PSA levels on three consecutive occasions (at least 3 months apart) post-radiation treatment.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

Histologically proven localized prostate cancer after receiving external radiation therapy;

Exclusion Criteria:

Patients unwilling or unable to give informed consent; Patients who received or are receiving chemotherapy; Patients previously treated with HIFU, cryotherapy, other salvage treatments, or with a trans-urethral resection of the prostate (TURP); Patients whose previous radiation therapy caused extensive cystitis and/or proctitis.

Patients suspected of Disseminated Intravascular Coagulation (DIC). Patients with prior history of coronary artery disease, angina pectoris, myocardial infarction, coronary angioplasty or coronary artery bypass graft, severe valvulopathy, cardiac failure, artrial fibrillation and / or sustained arrhythmia.

Patients whose cardiac status does not allow general anesthesia. Patients with history of thromboses or thrombo-embolisms. Patients with history of stroke or transient ischemic attack.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WST 09; Treatment with WST09-mediated VTP	Drug: Treatment with WST09 Vascular Photodynamic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prostate biopsy results at Month 6 after treatment.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of positive cores in the biopsies prior to and 6 months after the WST09-mediated VTP.		6 months
PSA levels taken periodically for 1 year after the procedure		Month 1,3,6 and 1 year
Hypoperfusion according to MRI at Week 1 after the procedure.		1 week and Month 6
Calculated PSA velocity before and after WST09-mediated VTP.		Month 1,3,6 and 1 year
Nadir of the PSA after the WST09-mediated VTP compared with the nadir of PSA after radiation therapy		Month 1,3,6 and 1 year
To assess the safety and tolerability of WST09-mediated VTP treatment in this patient population	The evaluation of safety will be based on reported adverse events, changes in vital signs and laboratory tests from the Treatment Visit until the study is completed.	Day1,Day 7, Month1,3,6,and 12

Collaborators and Investigators

• Sponsor: STEBA France
• Investigators: Principal Investigator: John Trachtenberg, MD FRCS(C), University Health Network, Princess Margaret Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: March 30, 2006
• First Submitted That Met QC Criteria: April 7, 2006
• First Posted (Estimate): April 10, 2006

Study Record Updates

• Last Update Posted (Estimate): June 2, 2010
• Last Update Submitted That Met QC Criteria: May 31, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Prostate cancer after radiation therapy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: HEC/WST0512 66N/WST 2.21