Fluciclovine PET for Prostate Cancer Recurrence

Recruiting at 1 trial location

Overseen By OHSU Diagnostic Radiology Research

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: OHSU Knight Cancer Institute

Must not be taking: Supplements, Herbal medications

Disqualifiers: Uncontrolled infection, Intercurrent illness, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 2

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this prospective cohort study is to investigate the role of Fluciclovine Positron Emission Tomography (PET) in patients with biochemical recurrence of prostate cancer (BCR) and a negative Prostate Specific Membrane Antigen (PSMA) PET, specifically, whether Fluciclovine PET can help detect local recurrence and whether the results of Fluciclovine PET can change management.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot start any new cancer treatments or supplements between the PSMA PET and Axumin PET/CT scans.

What data supports the effectiveness of the drug Fluciclovine PET for prostate cancer recurrence?

Fluciclovine PET, also known as Axumin, is effective for detecting recurrent prostate cancer because it targets cancer cell metabolism, which is often increased in prostate cancer. It has been approved by the FDA for this purpose and is considered more accurate than other imaging techniques for identifying cancer recurrence. ^{1 2 3 4 5}

Is Fluciclovine PET safe for humans?

The research articles do not provide specific safety data for Fluciclovine PET, but it has been approved by the US Food and Drug Administration for use in detecting prostate cancer recurrence, suggesting it has undergone safety evaluations. ^{1 2 3 6 7}

How is the drug Fluciclovine PET unique for prostate cancer recurrence?

Fluciclovine PET is unique because it uses a special imaging technique to detect prostate cancer recurrence by targeting cancer metabolism, specifically amino acid transport, which is often increased in prostate cancer. This provides more detailed information than conventional imaging, helping to differentiate between local and distant cancer recurrence. ^{1 2 3 5 6}

Research Team

Nadine Mallak, M.D.

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

This trial is for adults over 18 with prostate cancer that has come back, as shown by rising PSA levels, but who have a negative or unclear PSMA PET scan. They must understand and agree to the study's procedures after initial treatments like surgery or radiation.

Inclusion Criteria

Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed

PSA of 0.2 ng/mL or higher within 45 days of the scan

I had prostate cancer treatment, but scans don't clearly show if it's back.

Exclusion Criteria

Intercurrent illness or condition that would limit compliance with study requirements

I do not have any serious infections that are uncontrolled.

I haven't started any new cancer treatments or supplements between my PSMA and Axumin scans.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Imaging

Participants undergo Fluciclovine PET/CT within 30 days of a negative or equivocal PSMA PET scan

1 month

1 visit (in-person)

Follow-up

Participants are monitored for changes in management and clinical outcomes for 6 months post Fluciclovine-PET/CT

6 months

Standard-of-care visits with treating physician

Treatment Details

Interventions

• Fluciclovine PET

Trial Overview The study is looking at how well Fluciclovine PET scans can find where prostate cancer has returned in patients whose PSMA PET scans didn't show anything. It will also see if these Fluciclovine PET results lead to changes in patient care.

Participant Groups

Group I: Fluciclovine PET/CT Experimental Treatment 1 Intervention

Participants will undergo Fluciclovine PET/CT within 30 days of a negative or equivocal PSMA PET scan. After the Fluciclovine PET/CT, the patient will follow up with their treating physician as per standard-of-care. The research team will collect clinical and imaging data at 6 months post Fluciclovine-PET/CT.

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

Blue Earth Diagnostics

Industry Sponsor

Trials

43

Recruited

3,100+

Blue Earth Diagnostics, Inc

Collaborator

Trials

5

Recruited

160+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

Findings from Research

The FDA recently approved F-labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC, F-fluciclovine) PET/CT scans for detecting suspected prostate cancer recurrence in men with elevated PSA levels after treatment.

In a unique case study of a 77-year-old man, the scan revealed not only suspected recurrent prostate cancer but also advanced-stage breast cancer, highlighting the potential for incidental findings during prostate imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metastatic Male Breast Cancer With Increased Uptake on 18F-Fluciclovine PET/CT Scan. Gill, HS., Tade, F., Greenwald, DT., et al.[2018]

Fluciclovine PET/CT is a valuable imaging tool for evaluating suspected prostate cancer recurrence in patients with elevated PSA levels, providing critical information for patient management.

This imaging technique is particularly effective because it targets the upregulated amino acid transport in prostate cancer, offering significant advantages over conventional imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACR-ACNM Practice Parameter for the Performance of Fluorine-18 Fluciclovine-PET/CT for Recurrent Prostate Cancer. Savir-Baruch, B., Banks, KP., McConathy, JE., et al.[2019]

The PET tracer 18F-fluciclovine (Axumin) has been approved for use in men suspected of having recurrent prostate cancer after previous treatment, indicating its potential role in improving diagnosis.

Studies utilizing systematic sector-based histopathology as a reference standard have been conducted to evaluate the diagnostic accuracy of 18F-fluciclovine PET, highlighting its importance in clinical settings for prostate cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-Fluciclovine PET for Assessment of Prostate Cancer with Histopathology as Reference Standard: A Systematic Review. Seierstad, T., Hole, KH., Tulipan, AJ., et al.[2021]

Fluorine 18 (18F) fluciclovine (FACBC) is a radiolabeled amino acid analog that is more effectively taken up by prostate cancer cells than normal tissue, making it a promising tool for imaging recurrent prostate cancer.

The FDA approved FACBC PET in 2016 due to its superior accuracy compared to other imaging techniques, and its production does not require an on-site cyclotron, enhancing its availability for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of 18F-Fluciclovine PET for Detection of Recurrent Prostate Cancer. Gusman, M., Aminsharifi, JA., Peacock, JG., et al.[2020]

18F-Fluciclovine is effective for PET imaging in detecting biochemical recurrence of prostate cancer, as demonstrated in a case involving a 66-year-old man with metastatic castrate-resistant prostate cancer.

The imaging revealed incidental uptake in a left supraclavicular lymph node, which was later confirmed to be a high-grade, poorly differentiated carcinoma with neuroendocrine features, indicating that 18F-Fluciclovine can help identify aggressive cancer types beyond typical prostate cancer markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Poorly Differentiated Neuroendocrine Tumor With 18F-Fluciclovine Uptake in a Patient With Metastatic Castrate-Resistant Prostate Cancer. Abiodun-Ojo, OA., Akintayo, AA., Harik, LR., et al.[2023]

In a study involving 41 patients, the integration of (18)F-fluciclovine PET-CT into radiation therapy planning for prostate cancer significantly altered treatment target volumes in 83% of detected abnormalities, indicating its utility in improving treatment accuracy.

The use of (18)F-fluciclovine allowed for more precise targeting of cancerous areas, with 51% of changes occurring in lymph nodes, suggesting that this radiotracer can enhance the effectiveness of post-surgery radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image Guided Planning for Prostate Carcinomas With Incorporation of Anti-3-[18F]FACBC (Fluciclovine) Positron Emission Tomography: Workflow and Initial Findings From a Randomized Trial. Schreibmann, E., Schuster, DM., Rossi, PJ., et al.[2018]

The study found that the uptake of the PET imaging tracer [(18)F]fluciclovine in prostate cancer cells is primarily mediated by the Na(+)-dependent amino acid transporter ASCT2, which is influenced by the hormone dihydrotestosterone (DHT).

[(18)F]fluciclovine-PET imaging is effective for detecting both androgen-dependent prostate cancer and castration-resistant prostate cancer (CRPC), suggesting it could be a valuable tool for early intervention in CRPC treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[(14)C]Fluciclovine (alias anti-[(14)C]FACBC) uptake and ASCT2 expression in castration-resistant prostate cancer cells. Ono, M., Oka, S., Okudaira, H., et al.[2022]

References

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

Metastatic Male Breast Cancer With Increased Uptake on 18F-Fluciclovine PET/CT Scan. [2018]

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

ACR-ACNM Practice Parameter for the Performance of Fluorine-18 Fluciclovine-PET/CT for Recurrent Prostate Cancer. [2019]

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

18F-Fluciclovine PET for Assessment of Prostate Cancer with Histopathology as Reference Standard: A Systematic Review. [2021]

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

Review of 18F-Fluciclovine PET for Detection of Recurrent Prostate Cancer. [2020]

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

Poorly Differentiated Neuroendocrine Tumor With 18F-Fluciclovine Uptake in a Patient With Metastatic Castrate-Resistant Prostate Cancer. [2023]

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

Image Guided Planning for Prostate Carcinomas With Incorporation of Anti-3-[18F]FACBC (Fluciclovine) Positron Emission Tomography: Workflow and Initial Findings From a Randomized Trial. [2018]

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

[(14)C]Fluciclovine (alias anti-[(14)C]FACBC) uptake and ASCT2 expression in castration-resistant prostate cancer cells. [2022]