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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

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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)
Step 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
Step 3
Imaging procedure
A PET/CT scan will be performed after the injection
This combined imaging technique will create detailed pictures of your prostate
Step 4
Monitoring period
You will be monitored for 24 hours after receiving the injection to check for any potential side effects
Step 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
Step 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 trial?

7 criteria

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 trial?

15 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
Klagenfurt am Wörthersee, Austria
Verified
Uniklinikum Salzburg
Salzburg, Austria

Trial locations

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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.

(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

What is already known about the treatment

Florastamin (18F) - A radioactive diagnostic agent administered intravenously for PET/CT imaging, specifically designed for the detection and localization of clinically significant prostate cancer. This radiopharmaceutical tracer is currently being investigated in clinical trials as a diagnostic tool for patients with elevated PSA levels and suspected prostate cancer, working by binding to specific molecular targets in prostate cancer cells which can then be visualized through PET/CT scanning. As a diagnostic radiopharmaceutical, it belongs to the class of molecular imaging agents and represents a potential advancement in non-invasive prostate cancer detection and staging.

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.