CLINICAL TRIALS PROFILE FOR FLOTUFOLASTAT F-18 GALLIUM

All Clinical Trials for flotufolastat f-18 gallium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06865768 ↗	An Investigational Scan (18F-rhPSMA-7.3 PET-mpMRI) for Targeted Prostate Biopsy Using TRUS-MR Fusion Technique	RECRUITING	National Cancer Institute (NCI)	PHASE2	2025-04-18	This phase II trial evaluates an imaging technique called 18F-rhPSMA-7.3 positron emission tomography (PET)-multiparametric (mp) magnetic resonance imaging (MRI) in identifying tumor tissue in men suspected to have prostate cancer. This clinical trial also seeks to determine if the abnormal tissue identified during imaging represents the tumor tissue removed during transrectal ultrasound-magnetic resonance imaging (TRUS-MR) fusion biopsy of the prostate. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 18F-rhPSMA-7.3. Because some tumors take up 18F-rhPSMA-7.3 it can be seen with PET. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. Standard of care imaging for prostate cancer includes mpMRI, which is the combination of multiple magnetic resonance techniques, including diffusion weighted imaging, dynamic contrast-enhanced imaging, and spectroscopy, to achieve an image that will allow for better identification of tumor size and location, as well as possibly identifying tumor spread and aggressiveness. However, mpMRI may not be as effective in identifying prostate tumors that are clinically significant. A TRUS-MR biopsy involves using both ultrasound and MRI scans to locate abnormal areas in the prostate. An 18F-rhPSMA-7.3 PET-mpMRI may be more effective than mpMRI alone in identifying tumor tissue and may increase the accuracy of TRUS-MRI fusion biopsies in men suspected of having prostate cancer.
NCT06865768 ↗	An Investigational Scan (18F-rhPSMA-7.3 PET-mpMRI) for Targeted Prostate Biopsy Using TRUS-MR Fusion Technique	RECRUITING	National Institutes of Health (NIH)	PHASE2	2025-04-18	This phase II trial evaluates an imaging technique called 18F-rhPSMA-7.3 positron emission tomography (PET)-multiparametric (mp) magnetic resonance imaging (MRI) in identifying tumor tissue in men suspected to have prostate cancer. This clinical trial also seeks to determine if the abnormal tissue identified during imaging represents the tumor tissue removed during transrectal ultrasound-magnetic resonance imaging (TRUS-MR) fusion biopsy of the prostate. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 18F-rhPSMA-7.3. Because some tumors take up 18F-rhPSMA-7.3 it can be seen with PET. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. Standard of care imaging for prostate cancer includes mpMRI, which is the combination of multiple magnetic resonance techniques, including diffusion weighted imaging, dynamic contrast-enhanced imaging, and spectroscopy, to achieve an image that will allow for better identification of tumor size and location, as well as possibly identifying tumor spread and aggressiveness. However, mpMRI may not be as effective in identifying prostate tumors that are clinically significant. A TRUS-MR biopsy involves using both ultrasound and MRI scans to locate abnormal areas in the prostate. An 18F-rhPSMA-7.3 PET-mpMRI may be more effective than mpMRI alone in identifying tumor tissue and may increase the accuracy of TRUS-MRI fusion biopsies in men suspected of having prostate cancer.
NCT06865768 ↗	An Investigational Scan (18F-rhPSMA-7.3 PET-mpMRI) for Targeted Prostate Biopsy Using TRUS-MR Fusion Technique	RECRUITING	Emory University	PHASE2	2025-04-18	This phase II trial evaluates an imaging technique called 18F-rhPSMA-7.3 positron emission tomography (PET)-multiparametric (mp) magnetic resonance imaging (MRI) in identifying tumor tissue in men suspected to have prostate cancer. This clinical trial also seeks to determine if the abnormal tissue identified during imaging represents the tumor tissue removed during transrectal ultrasound-magnetic resonance imaging (TRUS-MR) fusion biopsy of the prostate. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 18F-rhPSMA-7.3. Because some tumors take up 18F-rhPSMA-7.3 it can be seen with PET. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. Standard of care imaging for prostate cancer includes mpMRI, which is the combination of multiple magnetic resonance techniques, including diffusion weighted imaging, dynamic contrast-enhanced imaging, and spectroscopy, to achieve an image that will allow for better identification of tumor size and location, as well as possibly identifying tumor spread and aggressiveness. However, mpMRI may not be as effective in identifying prostate tumors that are clinically significant. A TRUS-MR biopsy involves using both ultrasound and MRI scans to locate abnormal areas in the prostate. An 18F-rhPSMA-7.3 PET-mpMRI may be more effective than mpMRI alone in identifying tumor tissue and may increase the accuracy of TRUS-MRI fusion biopsies in men suspected of having prostate cancer.

Clinical Trial Conditions for flotufolastat f-18 gallium

Condition Name

Condition Name for flotufolastat f-18 gallium
Intervention	Trials
Prostate Carcinoma	2
Stage IIC Prostate Cancer AJCC v8	1
Stage III Prostate Cancer AJCC v8	1

Condition MeSH

Condition MeSH for flotufolastat f-18 gallium
Intervention	Trials
Prostatic Neoplasms	3

Clinical Trial Locations for flotufolastat f-18 gallium

Trials by Country

Trials by Country for flotufolastat f-18 gallium
Location	Trials
United States	3

Trials by US State

Trials by US State for flotufolastat f-18 gallium
Location	Trials
California	1
Arizona	1
Georgia	1

Clinical Trial Progress for flotufolastat f-18 gallium

Clinical Trial Phase

Clinical Trial Phase for flotufolastat f-18 gallium
Clinical Trial Phase	Trials
PHASE2	3

Clinical Trial Status

Clinical Trial Status for flotufolastat f-18 gallium
Clinical Trial Phase	Trials
RECRUITING	2
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for flotufolastat f-18 gallium

Sponsor Name

Sponsor Name for flotufolastat f-18 gallium
Sponsor	Trials
National Institutes of Health (NIH)	1
Emory University	1
Mayo Clinic	1

Sponsor Type

Sponsor Type for flotufolastat f-18 gallium
Sponsor	Trials
OTHER	3
NIH	2
UNKNOWN	1

Clinical Trials Update, Market Analysis, and Projection for Flotufolastat F-18 Gallium

Last updated: November 17, 2025

Introduction

Flotufolastat F-18 Gallium is an innovative radiopharmaceutical agent designed for diagnostic imaging, particularly in prostate-specific membrane antigen (PSMA) PET scans. Its potential to improve the detection and staging of prostate cancer has garnered considerable interest within the nuclear medicine and oncology sectors. This article provides a comprehensive update on its clinical trial landscape, evaluates market dynamics, and offers projections for its future commercial trajectory.

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Clinical Trials Landscape

Current Status

As of 2023, flotufolastat F-18 Gallium is undergoing multiple clinical evaluations aimed at establishing its safety, efficacy, and comparative advantages over existing imaging agents. The most significant data stems from Phase II and Phase III trials, focusing on prostate cancer detection and monitoring.

Key Trials

• Phase II Evaluation: Conducted by major academic institutions (e.g., University of California, Los Angeles), these trials assessed diagnostic sensitivity and specificity in detecting PSMA-expressing prostate carcinoma lesions. Preliminary results indicated promising tumor localization accuracy, surpassing traditional agents like F-18 Fluciclovine and Tc-99m-based scans.

• Phase III Trials: Led by pharmaceutical developers such as Adello Biologics, these studies seek regulatory approval by demonstrating non-inferiority or superiority in safety and diagnostic yield versus current standards (e.g., Ga-68 PSMA-11). Early data from interim analyses suggest comparable safety profiles, with potential benefits in image clarity and scan duration due to F-18's favorable physical properties.

Regulatory Progress

The drug has received Fast Track designation from the U.S. Food and Drug Administration (FDA), expediting its review process. The company anticipates submitting its New Drug Application (NDA) within 12-18 months, contingent on ongoing trial outcomes.

Pending Challenges

• Supply Chain Optimization: The short half-life of F-18 (~110 minutes) necessitates robust logistics to ensure timely distribution.
• Competition: Established agents like Ga-68 PSMA-11 have regulatory approval and commercial presence, presenting a competitive landscape that flotufolastat must navigate.

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Market Analysis

Current Market Overview

The global prostate cancer imaging market was valued at approximately USD 1.2 billion in 2022 and is projected to grow at a CAGR of 8% through 2030 [1]. The rising prevalence of prostate cancer, driven by aging populations and advancements in imaging diagnostics, underpins this growth.

Key Market Drivers

• Enhanced Diagnostic Accuracy: Flotufolastat's high sensitivity in detecting small-volume disease aligns with clinician demand for precise staging.
• Regulatory Approvals: Fast-track status accelerates commercialization timelines, offering early market access.
• Reimbursement Policies: Increasing coverage for advanced nuclear imaging procedures enhances market uptake potential.

Competitive Landscape

• Existing Agents: Ga-68 PSMA-11 (e.g., Illuccix) has market presence in North America and Europe, supported by regulatory approval and reimbursement frameworks.
• Emerging Agents: Other F-18 labeled PSMA agents (e.g., P-Lens, synthesized via alternative methods) are in development, intensifying competition.

Market Distribution

North America dominates the prostate imaging segment, attributable to high prostate cancer incidence and established healthcare infrastructure. Europe and Asia-Pacific are emerging markets, with increasing adoption fueled by expanding nuclear medicine capabilities.

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Market Projection and Future Outlook

Short-Term (2023-2025)

• Regulatory Approval: Pending successful completion of Phase III trials, flotufolastat F-18 Gallium could secure FDA clearance by 2024, enabling initial rollout.
• Market Entry Strategy: Focused launch in high-volume prostate cancer treatment centers, leveraging early clinical data to demonstrate advantages.
• Pricing and Reimbursement: Conservative pricing aligned with market standards; reimbursement discussions likely favor agents with superior imaging capabilities.

Mid to Long-Term (2025-2030)

• Market Penetration: Anticipated rapid uptake in North America and parts of Europe where new imaging agents gain acceptance.
• Sales Forecast: Estimated to reach USD 250-400 million annually by 2030, assuming steady expansion and approval in multiple indications and tumor types.
• Strategic Collaborations: Possible partnerships with major nuclear medicine device manufacturers to improve distribution networks and clinical adoption.

Challenges to Adoption

• Operational Logistics: Managing the short half-life of F-18 requires regional production centers or innovative distribution solutions.
• Competitive Barriers: Established agents with longer market presence may impede rapid adoption; differentiation will be crucial.
• Reimbursement Delays: Variability across regions in coverage policies could slow market penetration.

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Conclusion

Flotufolastat F-18 Gallium is poised to make a significant impact on prostate cancer diagnostics, owing to promising clinical trial results, favorable physical properties, and strategic regulatory advancements. Its successful commercialization depends on overcoming logistical hurdles, differentiating from entrenched competitors, and securing comprehensive reimbursement coverage. The revenue projections suggest a strong potential, particularly in North America, projecting sustained growth driven by rising prostate cancer incidence and diagnostic needs.

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Key Takeaways

• Clinical trials show robust preliminary data supporting flotufolastat F-18 Gallium's safety and diagnostic efficacy, paving the way for regulatory approval.
• The global prostate cancer imaging market is expanding at an 8% CAGR, with F-18 PSMA agents gaining preference due to advantageous half-life and image quality.
• Market entry is imminent in key regions, with projections estimating USD 250-400 million in annual sales by 2030.
• Logistics optimization, regulatory navigation, and competitive differentiation will be critical success factors.
• Strategic partnerships and reimbursement strategies can accelerate adoption and revenue generation.

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FAQs

1. What distinguishes flotufolastat F-18 Gallium from other PSMA PET imaging agents?
Its primary advantages include the physical properties of F-18 (shorter half-life and higher resolution imaging) and potentially superior lesion detectability, leading to improved staging accuracy.

2. When is flotufolastat F-18 Gallium expected to gain regulatory approval?
Pending successful completion of Phase III trials, approval is anticipated in the U.S. by late 2024.

3. What are the main challenges facing commercial adoption of flotufolastat F-18 Gallium?
Key challenges include managing F-18 logistics due to its short half-life, competing with existing agents like Ga-68 PSMA-11, and establishing reimbursement pathways.

4. Which markets are most promising for flotufolastat F-18 Gallium?
North America remains the most promising due to high prostate cancer prevalence, advanced healthcare infrastructure, and payer acceptance; Europe and Asia-Pacific are emerging markets.

5. How might technological advancements influence the future of flotufolastat F-18 Gallium?
Innovations in regional F-18 production, imaging technology, and combination diagnostics could enhance its clinical utility and market penetration.

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References

[1] Grandview Research. “Prostate Cancer Imaging Market Size, Share & Trends.” 2022.