Prostate Hypoxia FAZA

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Other: 18F-Fluoroazomycin Arabinoside (18F-FAZA)

• Registration Number: NCT01567800
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-03-28
• Study First Posted: 2012-03-30
• Study Start: 2012-04
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-05
• Primary Completion: 2024-06
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET FAZA imaging	18F-Fluoroazomycin Arabinoside (18F-FAZA)	PET FAZA imaging of tumor hypoxia in patients with prostate cancer

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada