Prostate Hypoxia FAZA

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT01567800
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 155
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Other: 18F-Fluoroazomycin Arabinoside (18F-FAZA)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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 Start Date: Apr 1, 2012
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PET FAZA imaging PET FAZA imaging of tumor hypoxia in patients with prostate cancer	Other: 18F-Fluoroazomycin Arabinoside (18F-FAZA); PET scan with the radiolabelled tracer 18F-FAZA

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Health Network	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

• University Health Network, Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT01567800
• Other Study ID Numbers: UHN REB 11-0953-C
• First Posted: Mar 30, 2012
• Last Update Posted: Oct 6, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by University Health Network, Toronto: Procedure/Surgery: 18F-Fluoroazomycin Arabinoside (18F-FAZA)
• Additional relevant MeSH terms: Prostatic Neoplasms; Hypoxia; Fluoroazomycin arabinoside

Study Results

No Results Posted as of Oct 6, 2021