CLINICAL TRIALS PROFILE FOR AXUMIN

All Clinical Trials for Axumin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03263780 ↗	High Resolution PET-MRI Before Prostate Cancer HIFU	Completed	Blue Earth Diagnostics	Phase 2	2017-12-07	This prospective trial aims to determine if enhanced prostate imaging using two novel imaging technologies (high resolution DWI and 18F-fluciclovine PET-MRI) will detect prostate cancers not seen on standard multiparametric prostate MRI in patients considered candidates for focal HIFU.
NCT03263780 ↗	High Resolution PET-MRI Before Prostate Cancer HIFU	Completed	Timothy J. Daskivich	Phase 2	2017-12-07	This prospective trial aims to determine if enhanced prostate imaging using two novel imaging technologies (high resolution DWI and 18F-fluciclovine PET-MRI) will detect prostate cancers not seen on standard multiparametric prostate MRI in patients considered candidates for focal HIFU.
NCT03349463 ↗	Evaluation of Fluciclovine Uptake in Patients With Cervical, Ovarian Epithelial or Endometrial Cancers.	Recruiting	Blue Earth Diagnostics	Phase 4	2018-11-14	An important part of staging and deciding the method of treatment is knowing areas of how cancer is involved. Diagnostic imaging is often used to determine the location of the cancer using techniques like nuclear medicine, MRI (magnetic resonance imaging), CT (computerized tomography), and ultrasound. Each technique looks for cancer in different ways and are often used together to make a better determination of the extent of disease. One of the techniques used in cancer imaging is PET/CT. This technique combines a nuclear medicine study (PET or positron emission tomography) with CT performing both scans at the same time. PET/CT most commonly uses a radioactive sugar (FDG or fluorodeoxyglucose) to detect the cancer. The problem with FDG is that it is excreted by the kidneys and collected in the bladder. Even though the bladder is emptied prior to the scan, the FDG activity present there may interfere with the detection of small areas of cancer involvement in lymph nodes or adjacent areas. It is because of this that PET/CT using FDG is infrequently used in gynecological cancers. This purpose of this study is to evaluate if 18F-fluciclovine can be used to help determine the extent of gynecological cancers. 18F-fluciclovine (also known as AXUMIN) is a radioactive tracer which has been approved by the FDAFood and Drug Administration (FDA) for use in patients with prostate cancer. 18F-fluciclovine has much less excretion through the kidneys which improves the PET/CT imaging of the pelvis.
NCT03349463 ↗	Evaluation of Fluciclovine Uptake in Patients With Cervical, Ovarian Epithelial or Endometrial Cancers.	Recruiting	Bital Savir-Baruch	Phase 4	2018-11-14	An important part of staging and deciding the method of treatment is knowing areas of how cancer is involved. Diagnostic imaging is often used to determine the location of the cancer using techniques like nuclear medicine, MRI (magnetic resonance imaging), CT (computerized tomography), and ultrasound. Each technique looks for cancer in different ways and are often used together to make a better determination of the extent of disease. One of the techniques used in cancer imaging is PET/CT. This technique combines a nuclear medicine study (PET or positron emission tomography) with CT performing both scans at the same time. PET/CT most commonly uses a radioactive sugar (FDG or fluorodeoxyglucose) to detect the cancer. The problem with FDG is that it is excreted by the kidneys and collected in the bladder. Even though the bladder is emptied prior to the scan, the FDG activity present there may interfere with the detection of small areas of cancer involvement in lymph nodes or adjacent areas. It is because of this that PET/CT using FDG is infrequently used in gynecological cancers. This purpose of this study is to evaluate if 18F-fluciclovine can be used to help determine the extent of gynecological cancers. 18F-fluciclovine (also known as AXUMIN) is a radioactive tracer which has been approved by the FDAFood and Drug Administration (FDA) for use in patients with prostate cancer. 18F-fluciclovine has much less excretion through the kidneys which improves the PET/CT imaging of the pelvis.
NCT03373006 ↗	A Phase II Study to Evaluate Axumin PET/CT for Risk Stratification for Prostate Cancer	Completed	Desert Medical Imaging	Phase 2	2018-02-27	To investigate the utility of fluciclovine F 18 for evaluation for metastatic disease in men undergoing laser focal therapy of prostate cancer and the impact on inclusion for a focal therapy cohort.

Clinical Trial Conditions for Axumin

Condition Name

Condition Name for Axumin
Intervention	Trials
Brain Metastases	4
Prostate Cancer	3
Brain Metastases, Adult	2
Glioma	2

Condition MeSH

Condition MeSH for Axumin
Intervention	Trials
Prostatic Neoplasms	9
Brain Neoplasms	5
Neoplasms, Second Primary	4
Neoplasm Metastasis	4

Clinical Trial Locations for Axumin

Trials by Country

Trials by Country for Axumin
Location	Trials
United States	51

Trials by US State

Trials by US State for Axumin
Location	Trials
California	8
Pennsylvania	7
Florida	5
Utah	3
Louisiana	3

Clinical Trial Progress for Axumin

Clinical Trial Phase

Clinical Trial Phase for Axumin
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	4
Phase 2	8

Clinical Trial Status

Clinical Trial Status for Axumin
Clinical Trial Phase	Trials
Recruiting	13
Not yet recruiting	6
Completed	4

Clinical Trial Sponsors for Axumin

Sponsor Name

Sponsor Name for Axumin
Sponsor	Trials
Blue Earth Diagnostics	13
National Cancer Institute (NCI)	6
Blue Earth Diagnostics, Inc	3

Sponsor Type

Sponsor Type for Axumin
Sponsor	Trials
Other	29
Industry	17
NIH	6

Clinical Trials, Market Analysis, and Projections for AXUMIN

Introduction

AXUMIN, also known as fluciclovine F 18, is a diagnostic radiopharmaceutical used in positron emission tomography (PET) imaging to detect the recurrence of prostate cancer in men with elevated prostate-specific antigen (PSA) levels following prior treatment. Here, we will delve into the clinical trials, market analysis, and future projections for AXUMIN.

Clinical Trials Overview

Trial Design and Participants

The FDA approved AXUMIN based on evidence from two clinical trials, Trial 1 and Trial 2, conducted in the USA, Italy, and Norway. These trials involved male patients with suspected recurrence of prostate cancer due to rising PSA levels after radical prostatectomy and/or radiotherapy[1].

Trial 1: Efficacy Evaluation

Trial 1 evaluated 105 AXUMIN scans compared to histopathology results from biopsies of the prostate bed and suspicious lesions. The trial measured the successful detection of cancer lesions using PET/CT imaging. The results showed high sensitivity and specificity, with true positive rates of 96% and 92% for white and black patients, respectively[1].

Trial 2: Comparison with C11 Choline

Trial 2 compared the concordance between AXUMIN and C11 choline scans in patients with a median PSA value of 1.44 ng/mL. The agreement values between the two scans were 61%, 67%, and 77%, respectively, indicating a reasonable level of concordance[1].

Subgroup Analysis

The efficacy of AXUMIN was analyzed by race and age. The sensitivity and specificity varied slightly among different racial and age groups, but overall, AXUMIN demonstrated consistent performance across these subgroups[1].

Clinical Utility and Impact on Patient Management

LOCATE Study

A prospective, multicenter study known as the LOCATE study investigated the impact of AXUMIN PET/CT imaging on patient management. The study found that AXUMIN imaging changed clinical decision-making in more than one-third of patients, particularly in cases where standard-of-care imaging was negative or equivocal. Axumin-avid lesions were detected in 57% of patients with negative or equivocal findings on standard imaging[4].

EMPIRE-1 Study

The EMPIRE-1 study 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% rate with conventional imaging. This led to changes in treatment decisions and improved outcomes[4].

Market Analysis

Global Radiopharmaceuticals Market

The global radiopharmaceuticals market, which includes AXUMIN, is expected to grow significantly. In 2019, the market was valued at $6.1 billion and is projected to grow with a compound annual growth rate (CAGR) from 2018 through 2025. The demand for radiopharmaceuticals is driven by the rising prevalence of cancer and cardiovascular diseases, technological advancements, and increased healthcare expenditure[2].

Specific Market Trends for AXUMIN

AXUMIN, as a diagnostic agent for prostate cancer recurrence, benefits from the growing demand for targeted and precise diagnostic tools. The market for radiopharmaceuticals, particularly those used in PET imaging, is expected to expand due to their high accuracy and the increasing incidence of prostate cancer[2].

Regulatory and Reimbursement Updates

FDA and CMS Developments

AXUMIN has maintained its indication for detecting prostate cancer recurrence but faced challenges in expanding its use for other conditions. For instance, the application for using AXUMIN to diagnose glioma was withdrawn due to insufficient data to determine its benefit-risk profile[3].

Reimbursement Status

AXUMIN will regain its Pass-Through payment status for diagnostic imaging radiopharmaceutical reimbursement until September 30, 2026, following a CMS proposal. This change is expected to improve patient access and reimbursement for AXUMIN[5].

Safety and Adverse Reactions

Common Adverse Reactions

Clinical studies with AXUMIN reported adverse reactions in ≤ 1% of subjects, including injection site pain, injection site erythema, and dysgeusia. Hypersensitivity reactions, including anaphylaxis, are also possible, and emergency resuscitation equipment should be available[5].

Radiation Exposure

AXUMIN contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices are recommended to minimize radiation exposure to patients and healthcare providers[5].

Future Projections

Market Growth

Given the increasing demand for precise diagnostic tools and the growing incidence of prostate cancer, the market for AXUMIN is expected to continue growing. The radiopharmaceuticals market, driven by technological advancements and elevated healthcare expenditure, is projected to see significant expansion through 2025[2].

Clinical Utility Expansion

Studies like the LOCATE and EMPIRE-1 trials have demonstrated the clinical utility of AXUMIN in changing patient management decisions. Future studies may further establish AXUMIN’s role in various clinical settings, potentially expanding its indications and usage[4].

Key Takeaways

• Clinical Trials: AXUMIN was approved based on two clinical trials that demonstrated its efficacy in detecting prostate cancer recurrence.
• Clinical Utility: AXUMIN has been shown to change clinical decision-making in a significant proportion of patients, especially in cases with negative or equivocal standard imaging.
• Market Analysis: The global radiopharmaceuticals market is growing, driven by the increasing prevalence of cancer and technological advancements.
• Regulatory Updates: AXUMIN will regain its Pass-Through payment status, improving patient access and reimbursement.
• Safety Profile: AXUMIN has a generally safe profile but requires careful handling to minimize radiation exposure.

FAQs

What is AXUMIN used for?

AXUMIN is used in positron emission tomography (PET) imaging to detect the recurrence of prostate cancer in men with elevated prostate-specific antigen (PSA) levels following prior treatment[1].

How effective is AXUMIN in detecting prostate cancer recurrence?

AXUMIN has shown high sensitivity and specificity in detecting cancer lesions, with a detection rate of ~80% in some studies, significantly higher than conventional imaging[4].

What are the common adverse reactions associated with AXUMIN?

Common adverse reactions include injection site pain, injection site erythema, and dysgeusia. Hypersensitivity reactions, including anaphylaxis, are also possible[5].

Is AXUMIN approved for use in diagnosing glioma?

No, the application for using AXUMIN to diagnose glioma was withdrawn due to insufficient data to determine its benefit-risk profile[3].

How does AXUMIN impact patient management?

AXUMIN imaging has been shown to change clinical decision-making in more than one-third of patients, particularly in cases where standard-of-care imaging is negative or equivocal[4].

Sources

1. FDA: Drug Trials Snapshots: Axumin - FDA
2. BusinessWire: Radiopharmaceuticals Markets, 2025 - ResearchAndMarkets.com
3. EMA: Axumin - withdrawal of application for variation to marketing
4. Axumin.com: Axumin imaging-based guidance impacted clinical management
5. BusinessWire: Blue Earth Diagnostics, a Bracco Company, Lauds CMS Proposal to Support Patient Access Through Improved Payment for Specialized Diagnostic Radiopharmaceuticals