Prostate Hypoxia FAZA

NCT ID: NCT01567800

Last Updated: 2025-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2028-03-31

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PET FAZA imaging

PET FAZA imaging of tumor hypoxia in patients with prostate cancer

Group Type EXPERIMENTAL

18F-Fluoroazomycin Arabinoside (18F-FAZA)

Intervention Type OTHER

PET scan with the radiolabelled tracer 18F-FAZA

Interventions

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18F-Fluoroazomycin Arabinoside (18F-FAZA)

PET scan with the radiolabelled tracer 18F-FAZA

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Michael Milosevic, MD

Role: CONTACT

416-946-4501 ext. 2932

Facility Contacts

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Michael Milosevic, MD

Role: primary

416-946-4501 ext. 2932

Other Identifiers

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UHN REB 11-0953-C

Identifier Type: -

Identifier Source: org_study_id

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