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

University Health Network, Toronto1 site in 1 country18 target enrollmentApril 1, 2012

ConditionsProstate Cancer

Interventions18F-Fluoroazomycin Arabinoside (18F-FAZA)

Overview

Phase: Not Applicable
Intervention: 18F-Fluoroazomycin Arabinoside (18F-FAZA)
Conditions: Prostate Cancer
Sponsor: University Health Network, Toronto
Enrollment: 18
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 1, 2012

End Date

February 18, 2025

Last Updated

last month

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

University Health Network, Toronto

Responsible Party

Sponsor

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
•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

Arms & Interventions

PET FAZA imaging

PET FAZA imaging of tumor hypoxia in patients with prostate cancer

Intervention: 18F-Fluoroazomycin Arabinoside (18F-FAZA)

Outcomes

Primary Outcomes

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