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


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Authority:

Canada: Ethics Review Committee

Study ID:

UHN REB11-0953-C

NCT ID:

NCT01567800

Start Date:

April 2012

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Procedure/Surgery: 18F-Fluoroazomycin Arabinoside (18F-FAZA)
  • Prostatic Neoplasms
  • Anoxia

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