Fluciclovine PET for Prostate Cancer Recurrence

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Fluciclovine PET scans can detect prostate cancer recurrences when other tests, such as PSMA PET scans, yield negative results. Fluciclovine PET may also assist doctors in determining the next steps in treatment. Men who have undergone prostate cancer treatment, suspect recurrence, and have a PSA level of 0.2 ng/mL or higher within 45 days of the scan might be suitable candidates. Participants will undergo a Fluciclovine PET scan and follow up with their doctor to discuss results and potential changes to their care. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for Fluciclovine PET?

Research has shown that Fluciclovine PET is generally safe for people. It uses a special dye to help doctors see inside the body. In past studies, many patients tolerated it well, and no major safety concerns arose. Since Fluciclovine PET is already approved for other uses, this further suggests its safety.

However, a negative result does not mean cancer is gone, and a positive result does not always confirm cancer's return. This means the test can sometimes yield unclear results, but this does not affect safety. Prospective trial participants should discuss any concerns with their doctor. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Fluciclovine PET is unique because it offers a new way to detect prostate cancer recurrence, especially when conventional methods like PSMA PET scans return unclear results. Unlike traditional imaging techniques, Fluciclovine PET/CT utilizes a specialized radiotracer that targets amino acid transport in cancer cells, potentially making it more effective in identifying cancerous activity that other scans might miss. Researchers are excited about this approach because it could lead to earlier and more accurate detection of recurrent prostate cancer, allowing for timely adjustments in patient care and treatment plans.

What evidence suggests that Fluciclovine PET is effective for detecting prostate cancer recurrence?

Research shows that Fluciclovine PET scans, which participants in this trial will undergo, effectively detect recurrent prostate cancer. Studies indicate these scans can identify cancer recurrence in up to 81% of patients. Specifically, in the prostate itself, the detection rate is about 61%. This scan has also prompted changes in treatment plans for approximately 59% to 63% of patients, highlighting its role in disease management. Overall, Fluciclovine PET serves as a useful tool for pinpointing the return of prostate cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Nadine Mallak, M.D.

Principal Investigator

OHSU Knight Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

Citations

1.

nature.com

nature.com/articles/s41391-021-00382-9

18F-Fluciclovine PET/CT performance in biochemical ...

F-Fluciclovine PET/CT was shown to impact patient management and outcomes. Two studies reported 59–63% of patients to have a management change ...

2.

axumin.com

axumin.com/about/efficacy

Axumin® (fluciclovine F 18) injection | Axumin Efficacy Data

Axumin demonstrated an overall (whole-body) detection rate of 81% · 61% (92) had positive findings within the prostate and prostate bed · 55% (83) had positive ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6910635/

Update on 18F-Fluciclovine PET for Prostate Cancer Imaging

Comprehensive clinical data demonstrate that 18F-fluciclovine is beneficial in the identification of the site of suspected recurrent disease.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04234399

Determination of the Diagnostic Detection Rate of Axumin ...

In a subsequent Emory study which studied Fluciclovine without a correlative imaging test, Fluciclovine scan detected recurrence in 72% (18/25) of patients with ...

5.

jnm.snmjournals.org

jnm.snmjournals.org/content/63/supplement_2/4075

Analysis of Prostate Cancer Imaging Agents: F-18 Fluciclovine ...

The objectives of this study are to: identify differences in image quality between Axumin and PSMA, summarize the advantages and disadvantages ...

6.

axumin.com

axumin.com/about/safety-side-effects

Axumin® (fluciclovine F 18) injection | Safety & Side Effects

A negative image does not rule out the presence of recurrent prostate cancer and a positive image does not confirm the presence of recurrent prostate cancer.

7.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2016/208054s000lbl.pdf

AXUMIN (fluciclovine F 18) injection, for intravenous use

For small lesions (less than 1cm in diameter) focal uptake greater than blood pool should be considered suspicious for prostate cancer recurrence.

8.

axumin.com

axumin.com/resources

Download Axumin ® (fluciclovine F 18) Resources

Safety Data Sheet: Health and safety ... A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence.

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8616758/

18F-Fluciclovine PET/CT performance in biochemical ...

18 F-Fluciclovine PET/CT shows good performance in patients with recurrent prostate cancer leading to measurable clinical benefits.

10.

pubs.rsna.org

pubs.rsna.org/doi/abs/10.1148/rg.2019180139

Review of 18F-Fluciclovine PET for Detection of Recurrent ...

Fluorine 18 fluciclovine, a radiotracer that may be relatively new to readers, is described, and a case-based primer on the use of this agent is provided.