NCT00312442

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2006

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 10, 2006

Completed
21 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 2, 2010

Status Verified

May 1, 2010

Enrollment Period

2.2 years

First QC Date

March 30, 2006

Last Update Submit

May 31, 2010

Conditions

Prostate Cancer

Keywords

Prostate cancer after radiation therapy

Outcome Measures

Primary Outcomes (1)

  • Prostate biopsy results at Month 6 after treatment.

    6 months

Secondary Outcomes (6)

  • Percentage of positive cores in the biopsies prior to and 6 months after the WST09-mediated VTP.

    6 months

  • PSA levels taken periodically for 1 year after the procedure

    Month 1,3,6 and 1 year

  • Hypoperfusion according to MRI at Week 1 after the procedure.

    1 week and Month 6

  • Calculated PSA velocity before and after WST09-mediated VTP.

    Month 1,3,6 and 1 year

  • Nadir of the PSA after the WST09-mediated VTP compared with the nadir of PSA after radiation therapy

    Month 1,3,6 and 1 year

  • +1 more secondary outcomes

Study Arms (1)

WST 09

EXPERIMENTAL

Treatment with WST09-mediated VTP

Drug: Treatment with WST09 Vascular Photodynamic therapy

Interventions

Treatment with WST09 Vascular Photodynamic therapyDRUG
WST 09

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven localized prostate cancer after receiving external radiation therapy;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • John Trachtenberg, MD FRCS(C)

    University Health Network, Princess Margaret Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 30, 2006

First Posted

April 10, 2006

Study Start

May 1, 2006

Primary Completion

July 1, 2008

Study Completion

December 1, 2009

Last Updated

June 2, 2010

Record last verified: 2010-05

Locations

CA(1)