Status:
TERMINATED
Phase II/III Study of WST09 in Prostate Cancer After Radiation Therapy
Lead Sponsor:
STEBA France
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
PHASE3
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 exte...
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 treatme...
Eligibility Criteria
Inclusion
- Histologically proven localized prostate cancer after receiving external radiation therapy;
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00312442
Start Date
May 1 2006
End Date
December 1 2009
Last Update
June 2 2010
Active Locations (1)
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1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9