Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2012-04-30
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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PET FAZA imaging
PET FAZA imaging of tumor hypoxia in patients with prostate cancer
18F-Fluoroazomycin Arabinoside (18F-FAZA)
PET scan with the radiolabelled tracer 18F-FAZA
Interventions
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18F-Fluoroazomycin Arabinoside (18F-FAZA)
PET scan with the radiolabelled tracer 18F-FAZA
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Locations
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University Health Network
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UHN REB 11-0953-C
Identifier Type: -
Identifier Source: org_study_id
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