Prostate Hypoxia FAZA

Study Overview
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Brief Summary
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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.

Official Title
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A Feasibility Study of Hypoxia Imaging in Patients With Prostate Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: 18F-Fluoroazomycin Arabinoside (18F-FAZA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET FAZA imaging<br>PET FAZA imaging of tumor hypoxia in patients with prostate cancer | Other: 18F-Fluoroazomycin Arabinoside (18F-FAZA)<br>* PET scan with the radiolabelled tracer 18F-FAZA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Procedure/Surgery: 18F-Fluoroazomycin Arabinoside (18F-FAZA)