NCT00305929

Brief Summary

This is a multi-centre, phase II, open-label, 12-month clinical trial for patients previously treated with WST09 (Tookad) who have positive prostate biopsies for cancer. The study aims at delivering a second WST09 treatment for the purpose of eradicating the localized prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2006

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 2, 2010

Status Verified

May 1, 2010

First QC Date

March 20, 2006

Last Update Submit

May 31, 2010

Conditions

Prostate Cancer

Keywords

Treatment of localized prostate cancerLocalized prostate cancer

Outcome Measures

Primary Outcomes (1)

  • Prostate biopsy

    12 months

Secondary Outcomes (1)

  • MRI, PSA

    7 days, 6 months

Study Arms (1)

1

EXPERIMENTAL

Treatment with Tookad VTP

Drug: Treatment with Tookad VTP

Interventions

Treatment with Tookad VTPDRUG
Also known as: WST09
1

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients previously treated with WST09-mediated VTP, with a positive biopsy of the prostate 6 months following treatment
  • Disease confined to the prostate
  • Life expectancy greater than 5 years

You may not qualify if:

  • Unwilling or unable to give informed consent
  • Patients who have received another treatment for their prostate cancer since their previous WST09-mediated VTP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Prostate Centre 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 20, 2006

First Posted

March 22, 2006

Study Start

March 1, 2006

Study Completion

December 1, 2007

Last Updated

June 2, 2010

Record last verified: 2010-05

Locations

CA(1)