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

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What is this study about?

This study focuses on patients with suspected prostate cancer who have elevated PSA (prostate-specific antigen) levels in their blood. The study will evaluate a new imaging method using Florastamin (18F), which is a radioactive substance given through an intravenous injection. This substance is used in combination with PET/CT scanning (a special type of medical imaging that combines two different scanning techniques) to help locate cancer in the prostate.

The purpose of this research is to determine how well Florastamin (18F) can detect significant prostate cancer in patients who have already undergone an MRI (magnetic resonance imaging) scan that showed unclear or low-risk findings. The medication being tested, also known as Prostavue or IASONFC303, is a solution that is injected into a vein. Each participant will receive a single dose of the study medication and undergo imaging procedures.

During the study, patients will receive the imaging agent and undergo a PET/CT scan. The results will be compared with other standard tests that are normally used to diagnose prostate cancer. The study will track how well this new imaging method performs in finding cancer compared to current diagnostic methods, and whether it leads to any changes in how doctors plan to treat their patients.

1 Initial medical imaging

A multi-parametric MRI scan of the prostate must have been performed within the last 3 months

The MRI results should show a PI-RADS score of 3 or lower (PI-RADS is a standardized reporting system for prostate imaging)

2 Medication administration

You will receive an injection of Prostavue (also known as florastamin) through an intravenous injection

The medication is a solution that will help create detailed images of your prostate

3 Imaging procedure

A PET/CT scan will be performed after the injection

This combined imaging technique will create detailed pictures of your prostate

4 Monitoring period

You will be monitored for 24 hours after receiving the injection to check for any potential side effects

5 Follow-up procedure

Based on your individual case, you will undergo either a biopsy (tissue sample collection) or a radical prostatectomy (surgical removal of the prostate)

The results will be compared with the imaging findings

6 Study duration

The overall study period runs from July 2024 to October 2027

Your individual participation duration will depend on your specific treatment plan

Who Can Join the Study?

  • Must be a male
  • Must be at least 18 years old
  • Must have either:
    – A PSA level of 10 ng/mL or higher (PSA is a protein produced by the prostate that can be measured in blood) and/or
    – A PSA density of 0.26 ng/mL² or higher (PSA density is the PSA level divided by prostate volume)
  • Must have had an MRI scan of the prostate within the last 3 months with a PI-RADS score of 3 or less (PI-RADS is a standardized reporting system for prostate MRI findings)
  • Must have their MRI data available for review by the study team
  • Must be scheduled for either:
    – A prostate biopsy (a procedure to take tissue samples from the prostate) or
    – A radical prostatectomy (surgery to remove the entire prostate)
  • Must provide signed informed consent to participate in the study

Who Cannot Join the Study?

  • Previous prostate cancer diagnosis or treatment
  • Known allergies or hypersensitivity to radioactive contrast agents
  • Age below 18 or above 75 years
  • Female patients (study is for male participants only)
  • Previous prostate surgery or radiation therapy
  • Unable to undergo PET/CT scanning (a specialized medical imaging test)
  • Participation in other clinical trials within the last 30 days
  • Inability to provide informed consent
  • Current urinary tract infection or prostatitis (inflammation of the prostate)
  • Medical conditions that could interfere with PSA levels (prostate-specific antigen, a blood test marker)
  • Recent prostate manipulation (including biopsy) within the past 6 weeks
  • Contraindications to magnetic resonance imaging (MRI)
  • Severe claustrophobia (fear of enclosed spaces)
  • Implanted medical devices incompatible with imaging procedures
  • Inability to lie still for the duration of imaging procedures

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Landeskrankenanstalten-Betriebsgesellschaft Kabeg Klagenfurt am Wörthersee Austria
Uniklinikum Salzburg Salzburg Austria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
10.07.2024

Trial locations

Investigated drugs:

Florastamin (18F) is a radioactive imaging agent used in PET/CT scans. It is injected into the body to help doctors see and locate prostate cancer cells. This imaging medication makes cancer cells visible during the scan, which helps to determine if cancer is present and where it is located in the prostate. It is particularly useful when combined with other diagnostic tests like MRI to provide a more complete picture of potential prostate cancer.

Investigated diseases:

Prostate Cancer – A disease that develops in the prostate gland, which is part of the male reproductive system. The condition typically begins when normal prostate cells start to grow uncontrollably and form masses of abnormal cells. The disease usually develops slowly over many years, starting from the inner parts of the prostate gland. As it progresses, the abnormal growth can spread within the prostate and potentially to nearby tissues. Early stages of prostate cancer often cause no noticeable symptoms, though some men may experience urinary changes as the disease advances.

Trial ID:
2023-510421-14-00
Protocol code:
IASON FC303
Trial Phase:
Therapeutic confirmatory (Phase III)

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