Prostate Hypoxia FAZA
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
18F-Fluoroazomycin Arabinoside (18F-FAZA)
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Procedure/Surgery: 18F-Fluoroazomycin Arabinoside (18F-FAZA)
Eligibility 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
Sites / Locations
- University Health NetworkRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PET FAZA imaging
Arm Description
PET FAZA imaging of tumor hypoxia in patients with prostate cancer
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01567800
First Posted
March 23, 2012
Last Updated
October 3, 2023
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT01567800
Brief Title
Prostate Hypoxia FAZA
Official Title
A Feasibility Study of Hypoxia Imaging in Patients With Prostate Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Procedure/Surgery: 18F-Fluoroazomycin Arabinoside (18F-FAZA)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PET FAZA imaging
Arm Type
Experimental
Arm Description
PET FAZA imaging of tumor hypoxia in patients with prostate cancer
Intervention Type
Other
Intervention Name(s)
18F-Fluoroazomycin Arabinoside (18F-FAZA)
Intervention Description
PET scan with the radiolabelled tracer 18F-FAZA
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Milosevic, MD
Phone
416-946-4501
Ext
2932
Email
mike.milosevic@rmp.uhn.on.ca
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Milosevic, MD
Phone
416-946-4501
Ext
2932
Email
mike.milosevic@rmp.uhn.on.ca
First Name & Middle Initial & Last Name & Degree
Michael Milosevic, MD
12. IPD Sharing Statement
Learn more about this trial
Prostate Hypoxia FAZA
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