20 Participants Needed

FAZA PET Scan for Prostate Cancer

Michael Milosevic | Radiation Oncology
Overseen ByMichael Milosevic, MD
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking the drug disulfiram (Antabuse).

How does the FAZA PET Scan treatment for prostate cancer differ from other treatments?

The FAZA PET Scan for prostate cancer is unique because it uses a specific imaging agent to detect areas of low oxygen in tumors, which can help identify aggressive cancer cells. This approach is different from traditional treatments that focus on targeting androgen receptors or using general imaging techniques.12345

Eligibility Criteria

This trial is for men over 18 with prostate cancer who plan to receive radiotherapy, hormonal therapy, or other systemic treatments. They must be able to consent and lie supine for an hour. It's not for those over 136 kg, taking disulfiram, or with MRI contraindications (unless the target lesion isn't the prostate).

Inclusion Criteria

I plan to undergo radiotherapy with or without hormone therapy.
I am 18 years old or older.
My prostate cancer is advanced or has spread to other parts.
See 4 more

Exclusion Criteria

I cannot have an MRI if my cancer is in the prostate and needs PET FAZA imaging.
I cannot lie on my back for more than an hour.
I am currently taking disulfiram (Antabuse).
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo PET FAZA imaging to assess tumor hypoxia

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

  • 18F-Fluoroazomycin Arabinoside (18F-FAZA)
Trial OverviewThe study tests if a PET scan using a tracer called 18F-Fluoroazomycin Arabinoside (18F-FAZA) can detect low oxygen levels in prostate tumors better than current methods. This could influence future treatment strategies.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: PET FAZA imagingExperimental Treatment1 Intervention
PET FAZA imaging of tumor hypoxia in patients with prostate cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Findings from Research

The novel [18F]AlF-PSMA-137 probe demonstrated high specificity and binding affinity to prostate-specific membrane antigen (PSMA), with a radiochemical purity over 99% and effective tumor imaging capabilities in both preclinical and clinical settings.
In a pilot study involving 13 patients, [18F]AlF-PSMA-137 successfully detected 81 lesions, showing significant increases in tumor uptake over time, indicating its potential as an effective tool for diagnosing prostate cancer.
Preclinical evaluation and first in human study of Al18F radiolabeled ODAP-urea-based PSMA targeting ligand for PET imaging of prostate cancer.Ren, Y., Liu, C., Liu, T., et al.[2022]
Imaging with the marker (18)F-FMAU showed significantly higher uptake in castrated mice compared to noncastrated mice, indicating that androgen levels may influence cellular proliferation in prostate cancer.
CWR22 tumors exhibited higher uptake ratios of (18)F-FMAU compared to PC3 tumors, suggesting that (18)F-FMAU PET could be a valuable tool for characterizing prostate tumors based on their androgen sensitivity.
[18F]-2'-Fluoro-5-methyl-1-beta-D-arabinofuranosyluracil (18F-FMAU) in prostate cancer: initial preclinical observations.Jadvar, H., Yap, LP., Park, R., et al.[2021]
The PET imaging agent N-3-[18F]fluoropropylputrescine shows promising results for targeting prostate tumors, with a radiochemical yield of 7-10% and a specific activity exceeding 1.1 Ci/mumol after a synthesis time of 1.5 hours.
In vivo studies in male rats demonstrated high uptake in the prostate, especially when pretreated with specific compounds, suggesting that this agent could effectively differentiate prostate tissue from surrounding muscle and blood, enhancing its potential as a diagnostic tool.
N-3-[18F]fluoropropylputrescine as potential PET imaging agent for prostate and prostate derived tumors.Hwang, DR., Lang, LX., Mathias, CJ., et al.[2016]

References

Preclinical evaluation and first in human study of Al18F radiolabeled ODAP-urea-based PSMA targeting ligand for PET imaging of prostate cancer. [2022]
[18F]-2'-Fluoro-5-methyl-1-beta-D-arabinofuranosyluracil (18F-FMAU) in prostate cancer: initial preclinical observations. [2021]
N-3-[18F]fluoropropylputrescine as potential PET imaging agent for prostate and prostate derived tumors. [2016]
Synthesis of an Al18F radiofluorinated GLU-UREA-LYS(AHX)-HBED-CC PSMA ligand in an automated synthesis platform. [2023]
Prostate cancer PET bioprobes: synthesis of [18F]-radiolabeled hydroxyflutamide derivatives. [2016]