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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Prostate biopsy results at Month 6 after treatment.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

John Trachtenberg, MD FRCS(C)

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Princess Margaret Hospital

Authority:

Canada: Health Canada

Study ID:

HEC/WST0512 66N/WST 2.21

NCT ID:

NCT00312442

Start Date:

May 2006

Completion Date:

December 2009

Related Keywords:

  • Prostate Cancer
  • Prostate cancer after radiation therapy
  • Prostatic Neoplasms

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