CLINICAL TRIALS PROFILE FOR FLUCICLOVINE F-18

All Clinical Trials for Fluciclovine F-18

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00562315 ↗	FACBC PET/CT for Recurrent Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2007-10-01	Hypothesis:Anti-[18F]FACBC PET-CT will adequately detect local and extraprostatic recurrence, and lead to better characterization of disease status in restaging patients. This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to prostate tissue. The substance is called [18]FACBC and it is given in the form of an injection into a vein. After the substance reaches the prostate, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called [18]FDG is used for PET scans but this substance is eliminated by the kidneys and cannot reach the prostate. This substance called [18]FACBC is not eliminated by the kidneys and may allow tumors in the prostate to be seen better. It is sometimes difficult to tell if a growth on the prostate is cancer with scans or x-rays that are usually done. Anti-[18F]FACBC PET-CT will be compared to ProstaScint (In-capromab pendetide) which is the conventional imaging for prostate cancer. Investigators will be blinded of the intervention. This study will look at how the [18]FACBC goes into the prostate tissue and determine its ability to detect recurrent prostate cancer.
NCT00562315 ↗	FACBC PET/CT for Recurrent Prostate Cancer	Completed	David M. Schuster, MD	Phase 2	2007-10-01	Hypothesis:Anti-[18F]FACBC PET-CT will adequately detect local and extraprostatic recurrence, and lead to better characterization of disease status in restaging patients. This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to prostate tissue. The substance is called [18]FACBC and it is given in the form of an injection into a vein. After the substance reaches the prostate, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called [18]FDG is used for PET scans but this substance is eliminated by the kidneys and cannot reach the prostate. This substance called [18]FACBC is not eliminated by the kidneys and may allow tumors in the prostate to be seen better. It is sometimes difficult to tell if a growth on the prostate is cancer with scans or x-rays that are usually done. Anti-[18F]FACBC PET-CT will be compared to ProstaScint (In-capromab pendetide) which is the conventional imaging for prostate cancer. Investigators will be blinded of the intervention. This study will look at how the [18]FACBC goes into the prostate tissue and determine its ability to detect recurrent prostate cancer.
NCT02578940 ↗	Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of Prostate caNcer	Completed	IND 2 Results LLC	Phase 3	2015-11-01	The main aim is to assess the impact of using 18F-fluciclovine (as a PET imaging radiotracer) on the clinical and treatment decision required for managing patients with biochemically recurrent prostate cancer (BCR) who are being considered for salvage treatment with the intention of providing disease cure. Also, this study will consolidate the information regarding diagnostic performance of fluciclovine PET/CT in a large number of prospectively followed patients at several centres in the UK and assess the effect of PSA level on the likelihood of detecting cancer lesions by 18F-fluciclovine
NCT02578940 ↗	Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of Prostate caNcer	Completed	Innovate UK	Phase 3	2015-11-01	The main aim is to assess the impact of using 18F-fluciclovine (as a PET imaging radiotracer) on the clinical and treatment decision required for managing patients with biochemically recurrent prostate cancer (BCR) who are being considered for salvage treatment with the intention of providing disease cure. Also, this study will consolidate the information regarding diagnostic performance of fluciclovine PET/CT in a large number of prospectively followed patients at several centres in the UK and assess the effect of PSA level on the likelihood of detecting cancer lesions by 18F-fluciclovine
NCT02578940 ↗	Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of Prostate caNcer	Completed	Syne Qua Non Limited	Phase 3	2015-11-01	The main aim is to assess the impact of using 18F-fluciclovine (as a PET imaging radiotracer) on the clinical and treatment decision required for managing patients with biochemically recurrent prostate cancer (BCR) who are being considered for salvage treatment with the intention of providing disease cure. Also, this study will consolidate the information regarding diagnostic performance of fluciclovine PET/CT in a large number of prospectively followed patients at several centres in the UK and assess the effect of PSA level on the likelihood of detecting cancer lesions by 18F-fluciclovine
NCT02578940 ↗	Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of Prostate caNcer	Completed	Blue Earth Diagnostics	Phase 3	2015-11-01	The main aim is to assess the impact of using 18F-fluciclovine (as a PET imaging radiotracer) on the clinical and treatment decision required for managing patients with biochemically recurrent prostate cancer (BCR) who are being considered for salvage treatment with the intention of providing disease cure. Also, this study will consolidate the information regarding diagnostic performance of fluciclovine PET/CT in a large number of prospectively followed patients at several centres in the UK and assess the effect of PSA level on the likelihood of detecting cancer lesions by 18F-fluciclovine
NCT02680041 ↗	18F Fluciclovine (FACBC) PET/CT in Patients With Rising PSA After Initial Prostate Cancer Treatment	Completed	American College of Radiology	Phase 3	2016-06-01	This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent prostate cancer after curative-intent primary therapy and negative or equivocal findings on standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine PET/CT. Site clinicians will manage study subjects per standard practices and will document any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants will be followed for up to 6 months, with clinical data collected for this study. An interdisciplinary panel will provide expert guidance to local readers on request. The final reporting of the PET/CT scan will be a single report by the local reader following any such discussion.

Clinical Trial Conditions for Fluciclovine F-18

Condition Name

Condition Name for Fluciclovine F-18
Intervention	Trials
Prostate Cancer	8
Brain Metastases	6
Prostate Adenocarcinoma	3
Metastatic Prostate Carcinoma	3

Condition MeSH

Condition MeSH for Fluciclovine F-18
Intervention	Trials
Prostatic Neoplasms	18
Brain Neoplasms	9
Neoplasms, Second Primary	5
Neoplasm Metastasis	5

Clinical Trial Locations for Fluciclovine F-18

Trials by Country

Trials by Country for Fluciclovine F-18
Location	Trials
United States	96
United Kingdom	5

Trials by US State

Trials by US State for Fluciclovine F-18
Location	Trials
California	9
Pennsylvania	8
Utah	7
Georgia	7
Florida	6

Clinical Trial Progress for Fluciclovine F-18

Clinical Trial Phase

Clinical Trial Phase for Fluciclovine F-18
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	7
Phase 2	17

Clinical Trial Status

Clinical Trial Status for Fluciclovine F-18
Clinical Trial Phase	Trials
Recruiting	19
Completed	10
Not yet recruiting	9

Clinical Trial Sponsors for Fluciclovine F-18

Sponsor Name

Sponsor Name for Fluciclovine F-18
Sponsor	Trials
Blue Earth Diagnostics	21
National Cancer Institute (NCI)	11
Emory University	4

Sponsor Type

Sponsor Type for Fluciclovine F-18
Sponsor	Trials
Other	48
Industry	30
NIH	11

Clinical Trials, Market Analysis, and Projections for Fluciclovine F-18 (Axumin)

Introduction to Fluciclovine F-18 (Axumin)

Fluciclovine F-18, marketed as Axumin, is a positron emission tomography (PET) imaging agent specifically designed for detecting prostate cancer recurrence in men who have undergone prior treatments such as radical prostatectomy or radiotherapy, and who have elevated prostate-specific antigen (PSA) levels.

Clinical Trials and Efficacy

LOCATE Study

The LOCATE study, a prospective, US, multicenter, open-label trial, evaluated the impact of Axumin PET/CT imaging on patient management of biologically recurrent prostate cancer. The study found that Axumin imaging changed clinical management in a significant portion of patients. Specifically, Axumin-avid lesions were detected in 57% of patients who had negative or equivocal findings on standard-of-care imaging, with 30% of these lesions located in the prostate or prostate bed and 38% outside, including lymph nodes, soft tissues, and bone[1].

EMPIRE-1 Study

The EMPIRE-1 study, a single-center, open-label, phase 2/3 randomized trial, compared 3-year event-free survival in patients receiving radiotherapy based on conventional imaging versus Axumin PET/CT imaging. The study showed an ~80% overall detection rate with Axumin imaging, significantly higher than the 14% detection rate with conventional imaging. Axumin PET/CT changed clinical decision-making in more than one-third of patients, with no significant differences in toxicity between the two groups[1].

FDA Approval and Clinical Trials Data

The FDA approved Axumin based on evidence from two clinical trials that evaluated its efficacy in detecting cancer lesions using PET/CT imaging compared to biopsy results. These trials demonstrated that Axumin scans had a high positive predictive value, especially in patients with PSA levels greater than 1 ng/mL. The agreement between Axumin and C11 choline scans was also evaluated, showing agreement values ranging from 61% to 77%[3][5].

Market Analysis

U.S. Prostate Cancer Nuclear Medicine Diagnostics Market

The U.S. prostate cancer nuclear medicine diagnostics market is growing steadily, driven by the increasing incidence of prostate cancer and the need for advanced diagnostic tools. In 2022, this market was estimated at USD 75.06 million and is projected to reach USD 153.97 million by 2030, growing at a compound annual growth rate (CAGR) of 9.2% from 2023 to 2030[2].

Dominance of Fluorine-18

Fluorine-18 (F-18) based products, including fluciclovine F-18, dominate the market due to their efficient bio-distribution and relatively low urinary excretion. F-18 held a market share of 74.23% in terms of revenue in 2022[2].

Market Projections

Growth Drivers

The market for fluciclovine F-18 is expected to grow due to several factors:

• Increasing Incidence of Prostate Cancer: The rising incidence of prostate cancer and the need for accurate recurrence detection drive the demand for advanced imaging agents.
• Advancements in PET Imaging: Continuous advancements in PET/CT technology and the approval of new imaging agents like POSLUMA (flotufolastat F18) further enhance the market[2].
• Clinical Utility: Studies like the LOCATE and EMPIRE-1 trials have demonstrated the clinical utility of Axumin in changing patient management, which is likely to increase its adoption.

Competitive Landscape

The approval of new PET imaging agents, such as POSLUMA, indicates a competitive but growing market. POSLUMA, approved by the FDA in May 2023, is another agent used to detect PSMA-positive lesions in men with prostate cancer, adding to the array of diagnostic tools available[2].

Safety and Risks

Radiation Exposure

The use of fluciclovine F-18 contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk for cancer. However, the benefits of early and accurate detection of metastatic disease are considered to outweigh these risks[5].

Image Interpretation Errors

Fluciclovine F-18 uptake is not specific for prostate cancer and may occur with other types of cancer and benign prostatic hypertrophy. Therefore, clinical correlation, including potential histopathological evaluation, is recommended to verify imaging results[5].

Key Takeaways

• Clinical Efficacy: Axumin has shown significant efficacy in detecting prostate cancer recurrence, especially in patients with negative or equivocal findings on standard-of-care imaging.
• Market Growth: The U.S. prostate cancer nuclear medicine diagnostics market is expected to grow at a CAGR of 9.2% from 2023 to 2030.
• Dominance of F-18: Fluorine-18 based products, including fluciclovine F-18, dominate the market due to their favorable pharmacokinetic properties.
• Safety Considerations: While Axumin offers significant clinical benefits, it carries risks associated with radiation exposure and potential image interpretation errors.

FAQs

What is fluciclovine F-18 used for?

Fluciclovine F-18, marketed as Axumin, is used for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated PSA levels following prior treatment.

How effective is Axumin in detecting prostate cancer recurrence?

Axumin has been shown to detect prostate cancer recurrence in a significant portion of patients, especially those with negative or equivocal findings on standard-of-care imaging, with an overall detection rate of around 80% in some studies.

What are the risks associated with Axumin?

The use of Axumin contributes to cumulative radiation exposure, which is associated with an increased risk for cancer. Additionally, image interpretation errors can occur since fluciclovine F-18 uptake is not specific for prostate cancer.

How does Axumin compare to conventional imaging?

Axumin PET/CT imaging has a significantly higher detection rate compared to conventional imaging methods, such as bone scans and CT or MRI of the abdomen and pelvis.

What is the market outlook for fluciclovine F-18?

The market for fluciclovine F-18 is projected to grow at a CAGR of 9.2% from 2023 to 2030, driven by the increasing incidence of prostate cancer and the need for advanced diagnostic tools.

Sources

1. Axumin Imaging-Based Guidance Impacted Clinical Management - Axumin.com
2. U.S. Prostate Cancer Nuclear Medicine Diagnostics Market Report - Grandview Research
3. Drug Trials Snapshots: Axumin - FDA
4. Clinical Trials Using Fluciclovine F18 - National Cancer Institute
5. FDA Approval Document for Axumin - FDA Access Data

Last updated: 2025-01-01