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Prostate Hypoxia FAZA

This study is currently recruiting participants.
Verified September 2017 by University Health Network, Toronto
Sponsor:
ClinicalTrials.gov Identifier:
NCT01567800
First Posted: March 30, 2012
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Health Network, Toronto
  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: None (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:


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 ]

Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567800


Contacts
Contact: Michael Milosevic, MD 416-946-4501 ext 2932 mike.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 2932    mike.milosevic@rmp.uhn.on.ca   
Principal Investigator: Michael Milosevic, MD         
Sponsors and Collaborators
University Health Network, Toronto
  More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01567800     History of Changes
Other Study ID Numbers: UHN REB 11-0953-C
First Submitted: March 23, 2012
First Posted: March 30, 2012
Last Update Posted: September 20, 2017
Last Verified: September 2017

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

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