Measuring oxygen levels in prostate cancer using PET scans
A Feasibility Study of Hypoxia Imaging in Patients With Prostate Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)
This study is testing a special type of PET scan to see if measuring low oxygen levels in prostate cancer patients can help understand how the cancer grows and responds to treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT01567800 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate low oxygen levels, known as hypoxia, in prostate cancer patients through a specialized imaging technique called positron emission tomography (PET) scan using 18F-Fluoroazomycin Arabinoside (18F-FAZA). The research focuses on understanding how hypoxia may influence the growth of prostate cancer and its response to treatments such as radiotherapy and chemotherapy. By utilizing PET scans, the study seeks to provide a more effective and straightforward method for assessing hypoxia compared to previous techniques.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a histologic diagnosis of adenocarcinoma of the prostate, particularly those with bulky intermediate risk, high risk, or metastatic disease.
Not a fit: Patients who are unable to lie supine for more than 60 minutes or those without a diagnosis of prostate cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for prostate cancer by better understanding the role of hypoxia in tumor behavior.
How similar studies have performed: Other studies have shown promise in using PET scans for similar assessments, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Michael Milosevic, MD
- Email: mike.milosevic@rmp.uhn.on.ca
- Phone: 416-946-4501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.