Back to resultsPhase II/III Study of WST09 in Prostate Cancer After Radiation Therapy
Primary Purpose
Prostate Cancer
Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Treatment with WST09 Vascular Photodynamic therapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer after radiation therapy
Eligibility Criteria
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.
Sites / Locations
- Princess Margaret Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
WST 09
Arm Description
Treatment with WST09-mediated VTP
Outcomes
Primary Outcome Measures
Prostate biopsy results at Month 6 after treatment.
Secondary Outcome Measures
Percentage of positive cores in the biopsies prior to and 6 months after the WST09-mediated VTP.
PSA levels taken periodically for 1 year after the procedure
Hypoperfusion according to MRI at Week 1 after the procedure.
Calculated PSA velocity before and after WST09-mediated VTP.
Nadir of the PSA after the WST09-mediated VTP compared with the nadir of PSA after radiation therapy
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00312442
Brief Title
Phase II/III Study of WST09 in Prostate Cancer After Radiation Therapy
Official Title
Study of Photodynamic Therapy With WST09 in Patients With Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Terminated
Why Stopped
STEBA decided to develop WST11 that is soluble in aqueous solutions. The property of WST 11 make it safer and better candidate for therapeutic applications.
Study Start Date
May 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
STEBA France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer after radiation therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WST 09
Arm Type
Experimental
Arm Description
Treatment with WST09-mediated VTP
Intervention Type
Drug
Intervention Name(s)
Treatment with WST09 Vascular Photodynamic therapy
Primary Outcome Measure Information:
Title
Prostate biopsy results at Month 6 after treatment.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of positive cores in the biopsies prior to and 6 months after the WST09-mediated VTP.
Time Frame
6 months
Title
PSA levels taken periodically for 1 year after the procedure
Time Frame
Month 1,3,6 and 1 year
Title
Hypoperfusion according to MRI at Week 1 after the procedure.
Time Frame
1 week and Month 6
Title
Calculated PSA velocity before and after WST09-mediated VTP.
Time Frame
Month 1,3,6 and 1 year
Title
Nadir of the PSA after the WST09-mediated VTP compared with the nadir of PSA after radiation therapy
Time Frame
Month 1,3,6 and 1 year
Title
To assess the safety and tolerability of WST09-mediated VTP treatment in this patient population
Description
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.
Time Frame
Day1,Day 7, Month1,3,6,and 12
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Trachtenberg, MD FRCS(C)
Organizational Affiliation
University Health Network, Princess Margaret Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Phase II/III Study of WST09 in Prostate Cancer After Radiation Therapy
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