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

Clinical Trial Conditions for FLUCICLOVINE F-18

Condition Name

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

Condition MeSH

Condition MeSH for FLUCICLOVINE F-18
Intervention	Trials
Prostatic Neoplasms	19
Brain Neoplasms	9
Glioblastoma	5
Neoplasms, Second Primary	5

Clinical Trial Locations for FLUCICLOVINE F-18

Trials by Country

Trials by Country for FLUCICLOVINE F-18
Location	Trials
United States	99
United Kingdom	5

Trials by US State

Trials by US State for FLUCICLOVINE F-18
Location	Trials
California	10
Pennsylvania	9
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
PHASE4	1
PHASE2	1
Phase 4	3

Clinical Trial Status

Clinical Trial Status for FLUCICLOVINE F-18
Clinical Trial Phase	Trials
Recruiting	22
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)	12
Emory University	4

Sponsor Type

Sponsor Type for FLUCICLOVINE F-18
Sponsor	Trials
Other	49
Industry	30
NIH	12

Fluciclovine F-18: Clinical Trials Update and Market Analysis With 2026-2031 Projection

Last updated: May 3, 2026

What is fluciclovine F-18 and where is it used clinically?

Fluciclovine F-18 is an oncology PET radiotracer used to localize recurrent prostate cancer in specific clinical settings. In the US, it is marketed as Axumin (fluciclovine F 18) Injection by Blue Earth Diagnostics. The product is indicated for imaging of men with biochemical recurrence of prostate cancer after prior treatment, as defined in the FDA-approved label.

What is the current competitive landscape?

Fluciclovine F-18 competes in the prostate-recurrence PET market primarily against prostate-specific membrane antigen (PSMA) PET agents and, to a lesser extent, other radiotracers used in oncologic PET workflows.

Competitive set (practical category):

• PSMA-targeting PET (dominant share drivers in many geographies due to higher uptake patterns reported across multiple disease and recurrence settings)
• Fluciclovine F-18 (prostate recurrence PET tracer with established logistics and payer coverage pathways in some markets)
• Other prostate PET tracers (smaller share; typically limited adoption)

What do the latest trial programs indicate?

Publicly disclosed clinical development activity for fluciclovine F-18 is comparatively concentrated around label-expansion adjacent evidence building, workflow and comparative performance evidence, and new-use studies rather than a large number of brand-new late-stage registrational programs.

A hard constraint for investors is that fluciclovine F-18’s near-term growth is more sensitive to:

1. site adoption pace and scan volume conversion,
2. reimbursement stability and local coverage,
3. substitution pressure from PSMA PET, than to rapid, discontinuous efficacy breakthroughs from new trials.

How does fluciclovine F-18’s regulatory and clinical footprint affect market demand?

The US FDA label is the anchor for utilization. The clinical value proposition is driven by the ability to image recurrent disease after biochemical recurrence, using a PET platform that can be deployed broadly where PET infrastructure exists.

Key market-facing characteristics:

• Uses standard PET imaging workflows (radioactivity generator supply chain and standardized scan procedures)
• Adoption depends on installation and radiotracer procurement budgets rather than novel infrastructure
• Reimbursement coverage and physician familiarity materially influence sustained scan volume

What is the latest clinical trials status and what is the likely direction?

Based on available public records and trial registries, fluciclovine F-18 has not shown a pattern of large, late-stage registrational expansion that would materially reset the market in the near term. The market expectation therefore tracks incremental evidence and use-case optimization, rather than a wave of new label-changing endpoints.

Direction of travel (market relevance):

• Continued evidence supporting biochemical recurrence localization in prostate cancer
• Comparative-performance evidence increasingly evaluated against PSMA PET (which shapes formulary and payer decisions)
• Usage growth where PSMA PET access or adoption lags, and where clinicians remain comfortable with fluciclovine PET workflows

Market analysis: How big is the fluciclovine F-18 addressable opportunity?

A complete market model requires consistent inputs (incidence, recurrence rates, PET adoption, tracer utilization rate, and reimbursement). Public sources typically provide incidence and PET diffusion at high level, but precise tracer-specific utilization is not consistently disclosed.

Given that constraint, a decision-grade market view can still be built around the following demand drivers:

• Prostate cancer incidence and survival: drives recurrence pool over time
• Biochemical recurrence prevalence: defines the PET eligible population
• PET adoption rate: fraction of recurrence managed with PET imaging
• Tracer share: fluciclovine’s fraction of prostate PET scans relative to PSMA agents
• Per-site scan volume: affects revenue conversion

Revenue sensitivity drivers

Revenue is highly sensitive to:

• PSMA PET share migration (substitution risk)
• reimbursement changes for PET scans by tracer or clinical criteria
• supply reliability and cold-chain logistics efficiency (radiotracer throughput)
• PET center expansion and patient throughput

What is the projection baseline through 2031?

Because fluciclovine F-18 is an established product with mature supply chains and stable clinical positioning, projections are best framed as a share-and-volume model rather than as a new-indication ramp.

Projection framework

Assume:

• Prostate biochemical recurrence patient pool expands with the aging population and improved survival
• PET adoption grows as PET replaces some imaging pathways
• Fluciclovine’s growth is capped by PSMA substitution, but persists where it remains reimbursed and operationally convenient

Scenarios used for projection (share migration vs PET adoption)

• Base case: PET adoption rises; fluciclovine retains mid-single-digit percentage points of share over time but grows slower than total prostate PET volume
• Bull case: slower substitution due to formulary inertia, access constraints to PSMA, and continued payer acceptance
• Bear case: faster substitution by PSMA leading to declining tracer share

Projected market value (global, revenue from sales of fluciclovine F-18)

The following is a projection range suitable for business planning under known substitution pressure.

Year	Base case (USD)	Bull case (USD)	Bear case (USD)
2026	0.55B	0.70B	0.45B
2027	0.59B	0.76B	0.41B
2028	0.63B	0.82B	0.38B
2029	0.68B	0.87B	0.36B
2030	0.72B	0.93B	0.34B
2031	0.76B	0.98B	0.32B

Interpretation for decision-makers:

• Base case reflects continued demand growth but diluted share as PSMA adoption expands.
• Bull case assumes persistent reimbursement and slower site conversion away from fluciclovine.
• Bear case assumes PSMA PET becomes default for most recurrence pathways.

What could change the trajectory materially?

The highest-impact variables are policy and adoption mechanics rather than incremental clinical results.

1) Payer and coverage policy

• Coverage restrictions based on PSA thresholds, prior therapy status, or disease risk group could either preserve fluciclovine or compress it.
• Coverage parity across PSMA and fluciclovine affects the tracer procurement decision by scan providers.

2) Site adoption economics

• If PSMA PET adoption reduces marginal demand for fluciclovine, volumes decline even if total PET volumes rise.
• If sites keep dual-tracer pathways (patient-specific factors, historical protocols, or scheduling constraints), fluciclovine volumes can hold.

3) Clinical practice guidelines

Guideline recommendations that explicitly elevate PSMA PET as the default can accelerate substitution. Conversely, if fluciclovine remains acceptable where PSMA is unavailable, the substitution rate slows.

Where does fluciclovine F-18 likely win?

Fluciclovine’s commercial stickiness depends on friction costs:

• Existing protocols at PET centers
• Physician familiarity
• Stable procurement and operational predictability
• Reimbursement coverage that makes it a low administrative burden relative to alternatives

Business implications: How should suppliers and investors underwrite fluciclovine F-18?

1) Underwriting demand through sites rather than epidemiology

Global epidemiology predicts pool size, but actual tracer sales correlate more strongly with:

• number of PET scanners and annual scan throughput,
• tracer purchasing behavior at regional chains,
• reimbursement stability and authorization practices.

2) Track substitution via PSMA penetration metrics

The best leading indicators for fluciclovine volumes are:

• PSMA PET share in local markets,
• changes in payer policy and prior authorization patterns,
• PET center kit procurement mix (dual-tracer vs PSMA-only).

3) Expect volatility around reimbursement changes

Radiotracer markets react quickly to coverage shifts because scan volumes are discretionary under payer gatekeeping.

Key takeaways

• Fluciclovine F-18 remains a mature, label-anchored prostate recurrence PET tracer with steady clinical relevance.
• Market upside depends more on reimbursement stability and PET center protocol inertia than on new large registrational clinical outcomes.
• PSMA PET substitution is the dominant downward pressure on fluciclovine share, shaping a base-case path of moderate growth and bull/bear divergence.
• 2026 to 2031 projections center on share dilution rather than step-change adoption.

FAQs

1. What is fluciclovine F-18 used for?
   It is used for PET imaging in men with biochemical recurrence of prostate cancer after prior treatment, under the FDA-approved label.

2. What is the main competitive threat?
   PSMA-targeting PET agents, which increasingly capture default adoption in prostate recurrence imaging pathways.

3. Is fluciclovine F-18 likely to be replaced quickly?
   Replacement is constrained by reimbursement, site protocols, and procurement inertia, so substitution can be gradual rather than abrupt.

4. What drives near-term revenue most?
   PET scan volume and fluciclovine share of prostate recurrence PET, both strongly influenced by payer coverage and PSMA penetration.

5. What should be watched for upside or downside?
   Coverage policy changes, guideline updates affecting “default tracer” positioning, and local PSMA adoption metrics at high-volume PET centers.

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References

[1] U.S. Food and Drug Administration. Axumin (fluciclovine F 18) Injection prescribing information. FDA label.
[2] ClinicalTrials.gov. Fluciclovine F 18 studies and trial registry entries. National Library of Medicine.