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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00312442
• Other study ID #: HEC/WST0512 66N/WST 2.21
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: March 30, 2006
• Last updated: May 31, 2010
• Start date: May 2006
• Est. completion date: December 2009

Study information

• Verified date: May 2010
• Source: STEBA France
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: December 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Treatment with WST09 Vascular Photodynamic therapy

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
STEBA France

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate biopsy results at Month 6 after treatment.		6 months	No
Secondary	Percentage of positive cores in the biopsies prior to and 6 months after the WST09-mediated VTP.		6 months	No
Secondary	PSA levels taken periodically for 1 year after the procedure		Month 1,3,6 and 1 year	No
Secondary	Hypoperfusion according to MRI at Week 1 after the procedure.		1 week and Month 6	No
Secondary	Calculated PSA velocity before and after WST09-mediated VTP.		Month 1,3,6 and 1 year	No
Secondary	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	No
Secondary	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	Yes