Prostate Hypoxia FAZA

NCT01567800 | Completed

• 1 other identifier: 11-0953
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Procedure/Surgery: 18F-Fluoroazomycin Arabinoside (18F-FAZA)

Outcome Measures

Primary Outcomes (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

Study Arms (1)

PET FAZA imaging

EXPERIMENTAL

PET FAZA imaging of tumor hypoxia in patients with prostate cancer

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

Interventions

18F-Fluoroazomycin Arabinoside (18F-FAZA) OTHER

PET scan with the radiolabelled tracer 18F-FAZA

PET FAZA imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

fluoroazomycin arabinoside

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: March 30, 2012
• Study Start: April 1, 2012
• Primary Completion: February 18, 2025
• Study Completion: February 18, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

CA (1)