NCT00308919

Brief Summary

To assess by MR Imaging the lesions induced by WST09-mediated photodynamic therapy (PDT) in patients with recurrent or persistent localized prostate cancer following definitive radiotherapy using different light doses and multiple illuminating fibres.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2004

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

April 1, 2004

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2006

Completed
Last Updated

June 22, 2010

Status Verified

May 1, 2010

First QC Date

March 28, 2006

Last Update Submit

June 18, 2010

Conditions

Recurrent or Persistent Localized Carcinoma of the Prostate Following Radiation Therapy Failure

Study Arms (1)

WST 09

EXPERIMENTAL

Treatment with WST09 Vascular Photodynamic therapy

Drug: WST09

Interventions

WST09DRUG

Treatment with WST09 Vascular Photodynamic therapy

WST 09

Eligibility Criteria

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

You may qualify if:

  • Ability to understand the patient's information sheet and to give written informed consent
  • Histologic proof of adenocarcinoma of the prostate 12 months or longer following definitive radiotherapy
  • Disease confined to the prostate (stage T1-N0 or X-M0 or X or T2-N0 or X -M0 or X) without evidence of regional and/or distant disease
  • Recent (within 90 days) CT scan of the abdomen and pelvis and radionucleotide bone scan or equivalent radiographic imaging confirming that no disease is outside of the prostate
  • Recent (within 3 months) cystoscopy if clinically warranted
  • Serum prostatic specific antigen (PSA) equal to or less than 20 ng/mL
  • Serum PSA showing two consecutive increases at least 2 weeks apart
  • Life expectancy more than 5 years, based on co-morbidity not related to prostate cancer
  • Ability to comply with the requirements of the study

You may not qualify if:

  • Patients who have received or are receiving chemotherapy for prostatic carcinoma or for any other cancer
  • Patients who are currently receiving any photosensitizing medications (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin)
  • Patients who have received a TURP (trans-urethral resection of the prostate)
  • Patients whose radiation therapy caused extensive cystitis and/or proctitis
  • Any condition, or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions)
  • History of non compliance with medical therapy and medical recommendations or an unwillingness or inability to complete patient self-administered questionnaires
  • Participation in a clinical study or receipt of an investigational treatment within the past 90 days
  • A history of porphyria
  • A history of significant allergies, particularly to Cremophor® and Benadryl®
  • A history of sun hypersensitivity or photosensitive dermatitis
  • Renal disorders (blood creatinine \> 1.5 x ULN)
  • Hepatic disorders (transaminases \> ULN, bilirubin\> ULN)
  • Hematological disorders: (White cells \< 2500/mm3, neutrophil\< 1500/mm3, platelets \<140,000/mm3, Hb \< 8 g/dl)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G2M9, Canada

Location

Related Publications (1)

  • Haider MA, Davidson SR, Kale AV, Weersink RA, Evans AJ, Toi A, Gertner MR, Bogaards A, Wilson BC, Chin JL, Elhilali M, Trachtenberg J. Prostate gland: MR imaging appearance after vascular targeted photodynamic therapy with palladium-bacteriopheophorbide. Radiology. 2007 Jul;244(1):196-204. doi: 10.1148/radiol.2441060398. Epub 2007 May 16.

    PMID: 17507719DERIVED

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John Trachtenberg, MD

    University Health Network, Toronto

    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 28, 2006

First Posted

March 30, 2006

Study Start

April 1, 2004

Study Completion

November 1, 2005

Last Updated

June 22, 2010

Record last verified: 2010-05

Locations

CA(1)