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

This study has been terminated.
(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.)
Sponsor:
Information provided by:
STEBA France
ClinicalTrials.gov Identifier:
NCT00312442
First received: March 30, 2006
Last updated: May 31, 2010
Last verified: May 2010
  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: Treatment with WST09 Vascular Photodynamic therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Photodynamic Therapy With WST09 in Patients With Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy

Resource links provided by NLM:


Further study details as provided by STEBA France:

Primary Outcome Measures:
  • Prostate biopsy results at Month 6 after treatment. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of positive cores in the biopsies prior to and 6 months after the WST09-mediated VTP. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • PSA levels taken periodically for 1 year after the procedure [ Time Frame: Month 1,3,6 and 1 year ] [ Designated as safety issue: No ]
  • Hypoperfusion according to MRI at Week 1 after the procedure. [ Time Frame: 1 week and Month 6 ] [ Designated as safety issue: No ]
  • Calculated PSA velocity before and after WST09-mediated VTP. [ Time Frame: Month 1,3,6 and 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To assess the safety and tolerability of WST09-mediated VTP treatment in this patient population [ Time Frame: Day1,Day 7, Month1,3,6,and 12 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 16
Study Start Date: May 2006
Study Completion Date: December 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WST 09
Treatment with WST09-mediated VTP
Drug: Treatment with WST09 Vascular Photodynamic therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312442

Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
STEBA France
Investigators
Principal Investigator: John Trachtenberg, MD FRCS(C) University Health Network, Princess Margaret Hospital
  More Information

No publications provided

Responsible Party: STEBA FRANCE
ClinicalTrials.gov Identifier: NCT00312442     History of Changes
Other Study ID Numbers: HEC/WST0512 66N/WST 2.21
Study First Received: March 30, 2006
Last Updated: May 31, 2010
Health Authority: Canada: Health Canada

Keywords provided by STEBA France:
Prostate cancer after radiation therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014