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Prostate Hypoxia FAZA

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ClinicalTrials.gov Identifier: NCT01567800
Recruitment Status : Recruiting
First Posted : March 30, 2012
Last Update Posted : September 20, 2017
Information provided by (Responsible Party):
University Health Network, Toronto

March 23, 2012
March 30, 2012
September 20, 2017
April 2012
March 2018   (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 ]
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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Intervention Model: Single Group Assignment
Masking: None (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.
March 2019
March 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age => 18 years
  • Histologic diagnosis of adenocarcinoma of the prostate
  • Bulky intermediate risk, high risk or metastatic prostate cancer

Bulky intermediate risk: cT1-2 with >50% of diagnostic biopsy cores containing cancer and Gleason 6 or 7 and prostate specific antigen (PSA) >10 and ≤20 OR

High risk:

cT1-2 with Gleason score ≥8; or cT1-2 with PSA >20; or cT3 OR N+ and/or M1 disease OR Newly diagnosed hormone-refractory prostate cancer - Intention to treat using radiotherapy +/- concurrent and adjuvant hormonal therapy

  • Intention to treat with radiotherapy, hormonal therapy, other systemic treatment for prostate cancer, or a combination of these according to the Princess Margaret Genitourinary Site policies.
  • Previous or concurrent anti-cancer therapy for the PET FAZA target lesion allowed
  • Ability to provide written informed consent to participate in the study

Exclusion Criteria:

  • Inability to lie supine for more than 60 minutes
  • Patients taking the drug disulfiram (Antabuse)
  • Contraindications for MRI: only applicable in cases where the PET FAZA target lesion is identified as the prostate gland. Patients with target lesions at other anatomic sites will not undergo MR imaging.
  • Patients weighing > 136 kg
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Contact: Michael Milosevic, MD 416-946-4501 ext 2932 mike.milosevic@rmp.uhn.on.ca
UHN REB 11-0953-C
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University Health Network, Toronto
University Health Network, Toronto
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University Health Network, Toronto
September 2017

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