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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

March 23, 2012
December 14, 2012
April 2012
April 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01567800 on ClinicalTrials.gov Archive Site
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Prostate Hypoxia FAZA
A Feasibility Study of Hypoxia Imaging in Patients With Prostate Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)

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.
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Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Prostate Cancer
Other: 18F-Fluoroazomycin Arabinoside (18F-FAZA)
PET scan with the radiolabelled tracer 18F-FAZA
Experimental: PET FAZA imaging
PET FAZA imaging of tumor hypoxia in patients with prostate cancer
Intervention: Other: 18F-Fluoroazomycin Arabinoside (18F-FAZA)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
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April 2014   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact: Michael Milosevic, MD 416-946-4501 ext 6513 michael.milosevic@rmp.uhn.on.ca
Canada
 
NCT01567800
11-0953-C
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University Health Network, Toronto
University Health Network, Toronto
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Not Provided
University Health Network, Toronto
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP