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?

This trial aims to explore how a special PET scan using 18F-Fluoroazomycin Arabinoside (18F-FAZA) can detect low oxygen levels in prostate cancer. Low oxygen may influence cancer growth and response to treatments like radiation and chemotherapy. The goal is to determine if PET scans can simplify this detection process. Men with prostate cancer that is bulky, high-risk, or has spread, and who plan to undergo treatments like radiotherapy, may be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future cancer diagnostics.

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).

What prior data suggests that this PET scan is safe for prostate cancer patients?

Research has shown that 18F-Fluoroazomycin Arabinoside (18F-FAZA) helps detect low oxygen levels in tumors. One study found that using 18F-FAZA PET scans is feasible, meaning it can be performed successfully without major issues. Another study demonstrated that this imaging method provides valuable insights into cancer, offering promise for understanding tumor behavior.

Although specific safety details are limited, testing 18F-FAZA in humans suggests it is generally considered safe for clinical use. Typically, new treatments must demonstrate they are well-tolerated and safe in earlier studies before further testing, meaning any serious side effects would have been identified and addressed.

In conclusion, while complete safety details of 18F-FAZA are not provided here, past research supports its use in imaging studies without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of 18F-Fluoroazomycin Arabinoside (18F-FAZA) because it offers a novel way to image tumor hypoxia in prostate cancer. Unlike standard imaging techniques, 18F-FAZA PET scans specifically target low-oxygen areas within tumors, which are often more aggressive and resistant to treatment. This specificity could help doctors better tailor treatment plans by identifying which areas of the tumor need more aggressive therapy. By providing a clearer picture of tumor biology, 18F-FAZA could potentially improve prostate cancer management and outcomes.

What evidence suggests that this PET scan is effective for detecting hypoxia in prostate cancer?

Research has shown that 18F-Fluoroazomycin Arabinoside (18F-FAZA), which participants in this trial will receive, can help detect low oxygen levels, known as hypoxia, in prostate cancer. An initial study successfully identified 81 cancerous areas in patients using 18F-FAZA, clearly highlighting the tumor regions. This finding suggests that 18F-FAZA might be useful for spotting hypoxia, which is important because low oxygen levels can affect how cancer responds to treatments like radiation and chemotherapy. Early studies also indicate that 18F-FAZA PET imaging could serve as a helpful marker, potentially allowing doctors to predict how the cancer will behave or respond to treatments before starting therapy. ^{3 6 7 8 9}

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.

Ability to provide written informed consent to participate in the study

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

Exclusion Criteria

I cannot have an MRI if my cancer is in the prostate and needs PET FAZA imaging.

You weigh more than 136 kilograms.

I cannot lie on my back for more than an hour.

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 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 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 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 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. clinicaltrial.be clinicaltrial.be/en/details/75487?per_page=100&only_recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Prostate Hypoxia FAZA 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 ...

2. withpower.com withpower.com/trial/faza-pet-scan-for-prostate-cancer-b1d7e

FAZA PET Scan for Prostate Cancer In a pilot study involving 13 patients, [18F]AlF-PSMA-137 successfully detected 81 lesions, showing significant increases in tumor uptake over time, indicating ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11435673/

18F-Fluoroazomycin Arabinoside (FAZA) PET/MR as a ... These preclinical studies suggest that 18F-FAZA-PET imaging prior to therapy initiation may serve as an effective clinical biomarker to identify ...

4. researchgate.net researchgate.net/publication/383588003_F-Fluoroazomycin_Arabinoside_FAZA_PETMR_as_a_Biomarker_of_Hypoxia_in_Rectal_Cancer_A_Pilot_Study

(PDF) F-Fluoroazomycin Arabinoside (FAZA) PET/MR as a ... The most reported primary pelvic tumor treated with RT was prostate cancer (77.3%), followed by cervical cancer (10.2%). ... outcomes ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4714693/

Prognostic value of 18F‐fluoroazomycin arabinoside PET ... 13 Clinical evaluation of FAZA is currently ongoing, and early results have been reported for head and neck, lung, prostate, and rectal cancers.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01567800

Study Details | NCT01567800 | Prostate Hypoxia FAZA A Feasibility Study of Hypoxia Imaging in Patients With Prostate Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA).

7. mdpi.com mdpi.com/2379-139X/10/9/102

18F-Fluoroazomycin Arabinoside (FAZA) PET/MR as a ... Imaging of hypoxia in LARC with 18 F-FAZA PET/MR is feasible. Blood pool as measured in the LV appears to be the most reliable reference for calculating the HF.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4074502/

PET radiopharmaceuticals for imaging of tumor hypoxia In this study, the prognostic significance of 18F-FAZA PET was confirmed (p=0.04): at a median follow-up of 19 months, disease-free survival was 93% for ...

9. clinicaltrial.be clinicaltrial.be/en/details/75487?per_page=100&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

Prostate Hypoxia FAZA 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 ...