Prostate Hypoxia FAZA

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01567800
• Other study ID #: UHN REB 11-0953-C
• Status: Recruiting
• Phase: N/A
• Start date: April 2012
• Est. completion date: March 2025

Study information

• Verified date: October 2023
• Source: University Health Network, Toronto
• Contact: Michael Milosevic, MD
• Phone: 416-946-4501
• Email: mike.milosevic[@]rmp.uhn.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• 18F-Fluoroazomycin Arabinoside (18F-FAZA)
PET scan with the radiolabelled tracer 18F-FAZA

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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