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Prostate Hypoxia FAZA

This study is currently recruiting participants.
Verified December 2012 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01567800
First received: March 23, 2012
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to look for low levels of oxygen (hypoxia) in prostate cancer using a special x-ray test called a positron emission tomography (PET)scan. Hypoxia may have an effect on how prostate cancer grows and responds to treatments like radiotherapy and chemotherapy. The use of PET scans to measure hypoxia may be better and simpler than the methods used previously.


Condition Intervention
Prostate Cancer
 Other: 18F-Fluoroazomycin Arabinoside (18F-FAZA)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Feasibility Study of Hypoxia Imaging in Patients With Prostate Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Number of patients treated with the PET tracer FAZA to image primary tumor hypoxia in patients with prostate cancer prior to treatment with radiotherapy +/- concurrent and adjuvant hormonal therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PET FAZA imaging
PET FAZA imaging of tumor hypoxia in patients with prostate cancer
 Other: 18F-Fluoroazomycin Arabinoside (18F-FAZA)
PET scan with the radiolabelled tracer 18F-FAZA

  Eligibility

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

Inclusion Criteria:

  • Age => 18 years
  • Histologic diagnosis of adenocarcinoma of the prostate

  • High risk prostate cancer

    1. cT1-2 with Gleason score => 8, or
    2. cT1-2 with Prostate Specific Antigen (PSA) => 20, or
    3. cT3
  • Intention to treat using radiotherapy +/- concurrent and adjuvant hormonal therapy
  • International Prostate Symptom Score (IPSS) < 15
  • No definitive anti-cancer therapy for prostate cancer prior to study entry
  • Ability to provide written informed consent to participate in the study

Exclusion Criteria:

  • Prior radical prostatectomy, radiotherapy or hormonal therapy for prostate cancer
  • Inability to lie supine for more than 60 minutes
  • Patients taking the drug disulfuram (Antabuse)
  • Contraindications for MRI
  • Patients weighing > 136 kg
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567800

Contacts
Contact: Michael Milosevic, MD 416-946-4501 ext 6513 michael.milosevic@rmp.uhn.on.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Michael Milosevic, MD     416-946-4501 ext 6513     michael.milosevic@rmp.uhn.on.ca    
Principal Investigator: Michael Milosevic, MD            
Sponsors and Collaborators
University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01567800     History of Changes
Other Study ID Numbers: 11-0953-C
Study First Received: March 23, 2012
Last Updated: December 14, 2012
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Procedure/Surgery: 18F-Fluoroazomycin Arabinoside (18F-FAZA)

Additional relevant MeSH terms:
Prostatic Neoplasms
Anoxia
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013