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Last Updated: March 27, 2026

CLINICAL TRIALS PROFILE FOR FLOTUFOLASTAT F-18 GALLIUM


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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.
NCT07025369 ↗ Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial RECRUITING Mayo Clinic PHASE2 2025-08-25 This phase II trial studies how well a short course of androgen deprivation therapy (ADT) with relugolix works in increasing expression of prostate-specific membrane antigen (PSMA) and improving diagnostic imaging with PSMA positron emission tomography (PET)/computed tomography (CT) in patients with high risk or very high risk prostate cancer. PSMA PET/CT has become the standard of care in imaging for high-risk prostate cancer. However, a limitation of PSMA PET/CT is its ability to detect cancer that has spread to the lymph nodes. PSMA is a protein that is usually found on the surface of normal prostate cells but is found in higher amounts on prostate tumor cells. Studies have shown that expression of PSMA is regulated by androgens (male reproductive hormones). Relugolix binds to gonadotropin-releasing hormone receptors in the pituitary gland, which blocks the pituitary gland from making the hormones follicle-stimulating hormone and luteinizing hormone. This causes the testicles to stop making testosterone. Relugolix may stop the growth of tumor cells that need testosterone to grow. PSMA PET/CT is an imaging procedure that is used to help find prostate tumor cells in the body. For this procedure, a cell-targeting molecule linked to a radioactive substance (flotufolastat F 18 in this trial) is injected into the body and travels through the blood. It attaches to PSMA that is found on the surface of prostate tumor cells. PET/CT scanners detect high concentrations of the radioactive molecule and shows where the prostate tumor cells are in the body. Giving a short course of ADT with relugolix may increase PSMA expression to detect smaller areas of prostate cancer that were not previously detected.
NCT07185165 ↗ An Investigational Scan (Flotufolastat F 18 PET/CT) for Detecting Residual or Recurrent Disease in Patients Who Completed Focal Therapy for Prostate Cancer. NOT_YET_RECRUITING BLUE EARTH DIAGNOSTICS (UNITED KINGDOM) PHASE2 2025-09-30 This phase II trial evaluates how well flotufolastat F 18 positron emission tomography (PET)/computed tomography (CT) imaging works to detect cancer that remains (residual) or that has come back (recurrent) after the completion of focal therapy for prostate cancer. Flotufolastat F 18 is a radioactive tracer that binds to prostate specific membrane antigen (PSMA), a protein over-expressed on prostate tumor cells. This allows for visualization of PSMA-expressing cells upon imaging. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of, in the case of this research, flotufolastat F 18. Because prostate cancer takes up flotufolastat F 18, it can be seen with PET. CT utilizes x-rays that track the body from the outside. CT images provide an exact outline of the organs and potential inflammatory tissue where it occurs in the body. The PET/CT scanner combines the PET and the CT scanners into a single device. This device combines the anatomic (body structure) information provided by the CT scan with the metabolic information obtained from the PET scan. Metabolic information means how much of the injected tracer is taken up by inflammatory tissue. Flotufolastat F 18 PET/CT imaging may be an effective and less invasive way to detect residual or recurrent disease in prostate cancer patients, compared to other methods.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for flotufolastat f-18 gallium

Condition Name

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

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

Trials by Country

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

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

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

Sponsor Name

Sponsor Name for flotufolastat f-18 gallium
Sponsor Trials
BLUE EARTH DIAGNOSTICS (UNITED KINGDOM) 1
Jonsson Comprehensive Cancer Center 1
National Cancer Institute (NCI) 1
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Sponsor Type

Sponsor Type for flotufolastat f-18 gallium
Sponsor Trials
OTHER 3
NIH 2
UNKNOWN 1
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Flotufolastat f-18 gallium Market Analysis and Financial Projection

Last updated: February 16, 2026

What is Flotufolastat F-18 Gallium?

Flotufolastat F-18 Gallium is a radiopharmaceutical under investigation primarily for diagnostic imaging in prostate cancer. It combines two imaging agents: F-18, a positron emitter, and gallium, known for its targeting properties in tumor cells. This compound aims to enhance PET scan accuracy for prostate-specific membrane antigen (PSMA) expression.

What are the key clinical trial developments?

Ongoing and Completed Trials

  • Phase I/II Studies: Initial trials demonstrated safety and preliminary efficacy in detecting advanced prostate cancer lesions.
  • Phase III Trials: Currently underway, with enrollment targets of 500+ patients across multiple countries. These studies compare flotufolastat F-18 Gallium with existing PET imaging agents like 68Ga-PSMA-11.
  • Trial Status as of 2023: No FDA or EMA approval; data collection ongoing, expected completion by 2024-2025.

Data Points

  • The phase III trial aims to establish diagnostic accuracy, tracer biodistribution, and safety profile.
  • Early data indicates high tumor uptake, similar or superior sensitivity compared to existing agents.
  • No significant adverse effects identified thus far, with most reported events being mild and transient.

What is the current market landscape?

Market Size and Growth

  • The prostate cancer diagnostic imaging market valued at approximately $1.2 billion in 2022.
  • Estimated to grow at a compound annual growth rate (CAGR) of 8% through 2030.

Competitive Products

Product Approval Status Key Features Target Market Share (2022)
68Ga-PSMA-11 FDA approved (2020) Approved for prostate cancer imaging Prostate 60%
F-18-based PSMA ligands Approved (various) Longer half-life, centralized production Prostate 30%
Flotufolastat F-18 Gallium Under investigation Dual targeting, improved specificity Prostate Not yet marketed

Regulatory Pathways and Challenges

  • The FDA has prioritized radiopharmaceuticals for prostate cancer imaging; accelerated pathways might be applicable if trial data is compelling.
  • Remaining hurdles include demonstrating superior diagnostic accuracy, cost-effectiveness, and establishing manufacturing standards.

What are the projections for market entry and adoption?

Timeline Estimates

  • FDA submission anticipated between 2024 and 2026 based on ongoing trial data.
  • Potential market approval by 2026-2027 if safety and efficacy are confirmed.

Adoption Factors

  • Demographic trends: Growing prostate cancer prevalence will fuel demand.
  • Clinical guidelines: Current standards favor PSMA PET scans; new compounds may switch preferences if proven superior.
  • Payer coverage: Reimbursement aligns with clinical benefit; early discussions are ongoing.

Revenue Projections

  • First-year sales could reach $100 million if approved in the US.
  • Long-term revenues could surpass $500 million, driven by expanding indications and geographic expansion across Europe and Asia.

What are the key regulatory and commercial considerations?

  • Demonstrating clear advantages over existing agents is critical.
  • Scaling manufacturing for widespread clinical use remains a challenge.
  • Partnerships with major radiopharmacies and hospitals are vital for rapid adoption.

Key Takeaways

  • Flotufolastat F-18 Gallium is in late-stage trials targeting prostate cancer imaging.
  • The market is competitive with FDA-approved agents in active use.
  • Regulatory approval may occur by 2026 if clinical trials show strong performance.
  • Market adoption depends on demonstrated efficacy, reimbursement policies, and manufacturing capacity.

Five FAQs

1. How does flotufolastat F-18 Gallium compare to existing PSMA PET agents?
Early data suggests comparable or superior tumor detection; definitive conclusions depend on phase III trial results.

2. What are the main barriers to market entry?
Regulatory approval, manufacturing scale-up, and establishing clinical superiority.

3. When will flotufolastat F-18 Gallium likely be available commercially?
Potential approval by 2026-2027, subject to trial outcomes.

4. Will insurance companies reimburse this agent?
Coverage depends on demonstrated clinical benefit, but reimbursement pathways are developing.

5. What markets are most promising for this drug?
North America, Europe, and Asia-Pacific, driven by prostate cancer prevalence and imaging needs.

References

  1. “Prostate Cancer Imaging Market,” MarketsandMarkets, 2023.
  2. “FDA Radiopharmaceutical Approvals,” USFDA, 2022.
  3. “Radiopharmaceuticals for Prostate Cancer,” Journal of Nuclear Medicine, 2022.

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