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| Sponsored by: |
STEBA France |
|---|---|
| Information provided by: | STEBA France |
| ClinicalTrials.gov Identifier: | NCT00312442 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Photodynamic therapy |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Study of Photodynamic Therapy With WST09 in Patients With Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy |
| Estimated Enrollment: | 85 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | December 2009 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Rupinder Dhaliwal | 905 338-3130 ext 236 | rupinderdhaliwal_1@hotmail.com |
| Canada, Ontario | |
| Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Rupinder Dhaliwal 905 338-3130 ext 236 rupinderdhaliwal_1@hotmail.com | |
| Principal Investigator: | John Trachtenberg, MD FRCS(C) | University Health Network, Princess Margaret Hospital |
More Information
| Study ID Numbers: | HEC/WST0512 66N/WST 2.21 |
| Study First Received: | March 30, 2006 |
| Last Updated: | July 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00312442 |
| Health Authority: | Canada: Health Canada |
|
Prostate cancer after radiation therapy |
|
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male |
Prostatic Neoplasms Recurrence Carcinoma |
|
Neoplasms Neoplasms by Site |
