FAZA PET Scan for Prostate Cancer

Overseen By Michael Milosevic, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Disulfiram

Disqualifiers: Inability to lie supine, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

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. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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.

My prostate cancer is advanced or has spread to other parts.

Ability to provide written informed consent to participate in the study

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).

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• 18F-Fluoroazomycin Arabinoside (18F-FAZA)

Trial Overview The 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.

How Is the Trial Designed?

Group I: PET FAZA imaging Experimental Treatment 1 Intervention

PET FAZA imaging of tumor hypoxia in patients with prostate cancer

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

N-3-[18F]fluoropropylputrescine as potential PET imaging agent for prostate and prostate derived tumors. Hwang, DR., Lang, LX., Mathias, CJ., et al.[2016]

The study successfully optimized the automatic synthesis of [18F]AlF-PSMA using a commercial platform, achieving high radiochemical purity (over 90%) and a yield of 18% from 500 to 2000 mCi of 18F, which is suitable for clinical use.

This method allows for the production of larger batches of the radiopharmaceutical, enabling higher doses for more patients and improving the ability to acquire late images for better diagnosis of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesis of an Al18F radiofluorinated GLU-UREA-LYS(AHX)-HBED-CC PSMA ligand in an automated synthesis platform. Giglio, J., Zeni, M., Savio, E., et al.[2023]

The study developed new fluorine-containing imaging agents that can potentially allow for noninvasive imaging of androgen receptor-positive prostate cancer, which is crucial since 80-90% of prostate cancers depend on androgens.

These imaging agents were successfully synthesized with high radiochemical purity and yield, suggesting they could be used for quantitative molecular imaging and possibly guide treatment decisions in prostate cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate cancer PET bioprobes: synthesis of [18F]-radiolabeled hydroxyflutamide derivatives. Jacobson, O., Bechor, Y., Icar, A., et al.[2016]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Preclinical evaluation and first in human study of Al18F radiolabeled ODAP-urea-based PSMA targeting ligand for PET imaging of prostate cancer. [2022]

2. England pubmed.ncbi.nlm.nih.gov

[18F]-2'-Fluoro-5-methyl-1-beta-D-arabinofuranosyluracil (18F-FMAU) in prostate cancer: initial preclinical observations. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

N-3-[18F]fluoropropylputrescine as potential PET imaging agent for prostate and prostate derived tumors. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Synthesis of an Al18F radiofluorinated GLU-UREA-LYS(AHX)-HBED-CC PSMA ligand in an automated synthesis platform. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Prostate cancer PET bioprobes: synthesis of [18F]-radiolabeled hydroxyflutamide derivatives. [2016]