Prostate Hypoxia FAZA | NCT01567800

Studies
Prostate Hypoxia FAZA

NCT01567800

Sponsor

University Health Network, Toronto

Status

Completed

Last Update Posted

Mar 6, 2026Actual

Enrollment

18Actual

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

18F-Fluoroazomycin Arabinoside (18F-FAZA)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Feb 18, 2025Actual

Completion Date

Feb 18, 2025Actual

First Submitted Date

Mar 23, 2012

First Submission Date that Met QC Criteria

Mar 28, 2012

First Posted Date

Mar 30, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2026

Last Update Posted Date

Mar 6, 2026Actual

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PET FAZA imaging	Experimental	PET FAZA imaging of tumor hypoxia in patients with prostate cancer	Other: 18F-Fluoroazomycin Arabinoside (18F-FAZA)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18F-Fluoroazomycin Arabinoside (18F-FAZA)	Other	PET scan with the radiolabelled tracer 18F-FAZA	PET FAZA imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms