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(9S,13S)-1-(1-(2-(2-(2-[18F]Fluoroethoxy)Ethoxy)Ethyl)-1H-1,2,3-Triazol-4-Yl)-3,11-Dioxo-2,4,10,12-Tetraazapentadecane-9,13,15-Tricarboxylicacid

This article discusses a clinical trial investigating the use of Florastamin (18F) PET/CT imaging for detecting clinically significant prostate cancer. The study focuses on patients with elevated PSA levels, suspicious MRI results, and clinical suspicion of prostate cancer. The trial aims to assess the effectiveness of this imaging technique in improving cancer detection and patient management.

Table of Contents

What is Florastamin (18F)?

Florastamin (18F), also known by its product name Prostavue, is a new diagnostic tool being studied for its potential in detecting prostate cancer[1]. It is classified as a radiopharmaceutical, which is a type of drug that contains a small amount of radioactive material used for diagnostic purposes[1].

How Does Florastamin (18F) Work?

Florastamin (18F) is used in combination with a special imaging technique called PET/CT (Positron Emission Tomography/Computed Tomography). This combination allows doctors to create detailed images of the body to locate potential prostate cancer cells[1]. The drug is designed to bind to specific targets in cancer cells, making them visible on the PET/CT scan.

Current Clinical Study

A clinical study is currently underway to evaluate the effectiveness of Florastamin (18F) PET/CT in locating significant prostate cancer in patients with certain risk factors[1]. The main goals of this study include:

  • Determining how accurate Florastamin (18F) PET/CT is in finding prostate cancer
  • Assessing how this new technique might change the way doctors diagnose and manage prostate cancer
  • Comparing the results of Florastamin (18F) PET/CT with other diagnostic tests

Who Can Participate in the Study?

The study is looking for participants who meet specific criteria[1]. These include:

  • Men with elevated PSA (Prostate-Specific Antigen) levels (≥10ng/mL) or high PSA density (≥0.26 ng/mL2). PSA is a protein produced by the prostate gland, and higher levels can indicate prostate cancer.
  • Patients who have had an MRI (Magnetic Resonance Imaging) scan with results that suggest a lower risk of prostate cancer (PI-RADS v2 ≤3).
  • Patients scheduled for a prostate biopsy or surgery to remove the prostate (radical prostatectomy).

Some factors that would prevent participation include[1]:

  • Previous treatment for prostate cancer
  • Known allergies to Florastamin (18F) or its ingredients
  • Life expectancy less than 6 months
  • Poor overall health status
  • Other active cancers

Potential Benefits of Florastamin (18F)

If proven effective, Florastamin (18F) PET/CT could offer several benefits for prostate cancer patients[1]:

  • More accurate detection of significant prostate cancer
  • Improved ability to locate cancer within the prostate
  • Potential to change how doctors diagnose and treat prostate cancer
  • Possibility of reducing unnecessary biopsies or treatments

How is Florastamin (18F) Administered?

Florastamin (18F) is given as an intravenous injection, which means it’s injected directly into a vein[1]. The dose is calculated based on the patient’s weight, with a maximum dose of 5 MBq/kg (megabecquerels per kilogram). After the injection, patients undergo a PET/CT scan to create images of their body.

Safety Considerations

As with any medical procedure, there are some safety considerations to keep in mind[1]:

  • Florastamin (18F) contains a small amount of radiation, but the risk is considered low for a single diagnostic procedure.
  • The study is monitoring for any side effects that might occur within 24 hours of receiving Florastamin (18F).
  • Patients with known allergies to the drug or its ingredients should not receive it.

It’s important to remember that Florastamin (18F) is still being studied, and more research is needed to fully understand its benefits and risks. If you think you might be eligible for this study or have questions about prostate cancer diagnosis, talk to your doctor about your options.

Aspect Details
Study Drug Florastamin (18F) / Prostavue
Primary Objective Analyze sensitivity of Florastamin (18F) PET/CT in locating clinically significant prostate cancer
Key Inclusion Criteria PSA ≥10ng/mL and/or PSA density ≥0.26 ng/mL2, PI-RADS v2 ≤3 MRI report
Key Exclusion Criteria Prior prostate cancer treatment, hypersensitivity to study drug, active malignancy
Primary Endpoint Percentage of true positive patients in locating clinically significant prostate cancer
Secondary Endpoints Specificity, impact on diagnostic thinking and patient management, correlation with PHI and histopathology
Safety Monitoring Adverse events observed during first 24 hours after administration

FAQ

  • What is Florastamin (18F) and how is it used in this study? Florastamin (18F) is a radioactive tracer used in PET/CT imaging. In this study, it's being evaluated for its ability to detect and locate clinically significant prostate cancer in patients with suspicious symptoms or test results.
  • Who is eligible to participate in this clinical trial? Eligible participants are those with PSA levels ≥10ng/mL and/or PSA density ≥0.26 ng/mL2, a PI-RADS v2 ≤3 report from a recent MRI, and are scheduled for a biopsy or radical prostatectomy. They must not have had any previous prostate cancer treatments.
  • What are the main objectives of this study? The main objective is to analyze the sensitivity of Florastamin (18F) PET/CT in locating clinically significant prostate cancer. Secondary objectives include assessing its specificity, impact on diagnostic thinking and patient management, and correlating results with other diagnostic methods.
  • How is the effectiveness of Florastamin (18F) PET/CT being measured? The effectiveness is being measured through various endpoints, including the percentage of true positive patients identified, the impact on diagnostic thinking and patient management, and correlation with histopathological results.
  • Are there any risks associated with participating in this trial? While specific risks are not detailed in the provided information, the study does monitor for adverse events during the first 24 hours after Florastamin (18F) administration. As with any medical procedure, there may be risks, which would be fully explained to participants before enrollment.

Ongoing Clinical Trials on (9S,13S)-1-(1-(2-(2-(2-[18F]Fluoroethoxy)Ethoxy)Ethyl)-1H-1,2,3-Triazol-4-Yl)-3,11-Dioxo-2,4,10,12-Tetraazapentadecane-9,13,15-Tricarboxylicacid

  • Study of Florastamin (18F) PET/CT Imaging for Detection of Significant Prostate Cancer in Patients with Elevated PSA Levels and Unclear MRI Results

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria

Glossary

  • Florastamin (18F): A radioactive tracer used in PET/CT imaging to detect and locate prostate cancer.
  • PET/CT: Positron Emission Tomography/Computed Tomography, an imaging technique that combines PET and CT scans to provide detailed pictures of the body's structures and functions.
  • PSA: Prostate-Specific Antigen, a protein produced by the prostate gland. Elevated levels may indicate prostate cancer.
  • PSA Density: A calculation that considers the size of the prostate and the PSA level, used to help determine the risk of prostate cancer.
  • PI-RADS: Prostate Imaging-Reporting and Data System, a standardized reporting system for prostate MRI results.
  • mpMRI: Multi-parametric Magnetic Resonance Imaging, an advanced form of MRI used to detect and characterize prostate cancer.
  • csPCa: Clinically Significant Prostate Cancer, cancer that is likely to impact a patient's prognosis and requires treatment.
  • Radical Prostatectomy: A surgical procedure to remove the entire prostate gland and surrounding tissues.
  • Sensitivity: The ability of a test to correctly identify patients with a disease.
  • Specificity: The ability of a test to correctly identify patients without a disease.
  • Net Reclassification Index (NRI): A statistical measure used to evaluate the improvement in prediction performance gained by adding a new marker to a set of baseline predictors.
  • Prostate Health Index (PHI): A blood test that combines three forms of PSA to provide a more accurate assessment of prostate cancer risk.
  • Histopathological: Relating to the microscopic examination of tissue to study the manifestations of disease.

References

  1. http://clinicaltrials.eu/trial/study-on-the-use-of-florastamin-18f-pet-ct-for-locating-prostate-cancer-in-patients-with-elevated-psa-levels-and-mri-suspicion/