Recruiting

Study on the Use of 18F-PSMA-1007 PET/MRI for Diagnosing Significant Prostate Cancer in Patients with Suspected Prostate Cancer

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 clinical trial is focused on diagnosing prostate cancer, a condition where cells in the prostate gland grow uncontrollably. The study uses a special imaging technique called 18F-PSMA PET/MRI. This method combines two types of scans: PET (Positron Emission Tomography) and MRI (Magnetic Resonance Imaging), to provide detailed images of the prostate. The treatment involves an injection of a substance known as [18F]PSMA-1007, which helps highlight cancer cells during the scan.

The purpose of the study is to determine how accurately the 18F-PSMA PET/MRI can diagnose significant prostate cancer. Participants will receive the [18F]PSMA-1007 injection, followed by the combined PET/MRI scan. This approach aims to offer a comprehensive view of the prostate in a single session, potentially improving the detection of cancerous areas.

Throughout the study, participants will undergo the imaging process and be monitored for any effects. The trial seeks to provide valuable information on the effectiveness of this imaging technique in identifying prostate cancer, which could lead to better diagnostic methods in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed. Participants must be 18 years or older and suspected of having clinically significant prostate cancer.
Participants must be able to undergo all required procedures and provide informed consent.
Step 2
Initial assessment
An initial assessment is conducted to gather baseline health information. This may include a physical examination and medical history review.
Step 3
Administration of medication
The medication [18F]PSMA-1007 is administered through an injection or infusion. This is done intravenously, meaning it is given directly into a vein.
The purpose of this medication is to help in the imaging process for diagnosing prostate cancer.
Step 4
Imaging procedure
A combined PET/MRI scan is performed. This imaging procedure helps in diagnosing prostate cancer by providing detailed pictures of the prostate.
The scan is a one-stop approach, meaning it combines two types of imaging in a single session.
Step 5
Follow-up and results
After the imaging procedure, results are analyzed to determine the presence and significance of prostate cancer.
The diagnostic accuracy is measured by sensitivity, specificity, and predictive values, which help in understanding the effectiveness of the imaging.

Who can join the trial?

5 criteria

Patients must be 18 years of age or older.
Patients must be identified as suspects for clinically significant prostate cancer. This means that there is a strong reason to believe they might have a type of prostate cancer that needs medical attention.
Patients must be able to undergo all protocol scrutiny. This means they should be able to participate in all the tests and procedures required by the study.
Patients must be able to provide informed consent. This means they understand the study and agree to participate.
Only male patients are eligible to participate in this study.

Who cannot join the trial?

4 criteria

Patients who do not have a clinical suspicion of prostate cancer. This means that if there is no reason to believe you might have prostate cancer, you cannot participate.
Patients who are not male. This study is only for male participants.
Patients who are not within the specified age range. The study is only for certain age groups.
Patients who are part of a vulnerable population. This means people who might need special protection or care, such as those with certain disabilities or conditions, cannot participate.

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Verified
Ospedale San Raffaele S.r.l.
Milan, Italy

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Investigated drugs

18F-PSMA is a special type of imaging agent used in a PET/MRI scan. It helps doctors see prostate cancer more clearly. This agent attaches to a protein found on prostate cancer cells, making them visible during the scan. The goal is to help doctors diagnose prostate cancer more accurately by highlighting areas where cancer might be present.

What is already known about the treatment

18F-PSMA PET/MRI – This medication is not a traditional drug but a diagnostic tool used in the form of a hybrid imaging technique combining PET and MRI scans. It is currently being studied for its effectiveness in diagnosing clinically significant prostate cancer. The main therapeutic indication is to help identify prostate cancer that is clinically relevant, meaning it may require treatment. At the molecular level, it works by using a radioactive tracer, 18F-PSMA, which binds to prostate-specific membrane antigen (PSMA) present in prostate cancer cells, allowing them to be visualized during the scan. This technique falls under the pharmacological classification of diagnostic radiopharmaceuticals.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often begins with small changes in the size and shape of prostate cells, which can develop into a tumor. As the disease progresses, the tumor may grow and potentially spread to nearby tissues or other parts of the body. The progression can vary significantly, with some cases remaining localized and slow-growing, while others may advance more rapidly. Symptoms may include difficulty urinating, blood in urine, or pelvic discomfort, but early stages often present no symptoms. The disease's progression is influenced by factors such as age, genetics, and lifestyle.