Prostate Hypoxia FAZA

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Mar 28, 2012

Keywords

ClinConnect Summary

This clinical trial, called Prostate Hypoxia FAZA, is studying low levels of oxygen in prostate cancer cells using a special type of imaging test known as a PET scan. Researchers want to understand how these low oxygen levels might affect the growth of prostate cancer and how well treatments like radiation and chemotherapy work. The PET scan is thought to be a better and simpler way to measure this oxygen level compared to older methods.

To participate in this study, you need to be a man aged 18 or older with a confirmed diagnosis of prostate cancer, specifically aggressive forms like bulky intermediate risk, high risk, or metastatic cancer. If you join, you can expect to undergo a PET scan to assess your cancer. Participants should be able to lie still for about an hour, and certain medications or health conditions might prevent some people from being eligible. This trial is currently looking for volunteers, so if you think you might qualify and are interested, it could be a good opportunity to contribute to research in prostate cancer.

Gender

MALE

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