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Study on the Use of [18F]PSMA-1007 PET/CT Imaging for Detecting Prostate Cancer in Patients with Newly Diagnosed High-Risk or Very-High-Risk Conditions

Verified siteRegistered drugNo 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 studying prostate cancer, specifically in patients who have been newly diagnosed with high-risk or very-high-risk forms of the disease. The study will use a special imaging technique called [18F]PSMA-1007 PET/CT. This method combines two types of scans: a PET scan, which shows how tissues and organs are functioning, and a CT scan, which provides detailed images of the inside of the body. The purpose of the study is to evaluate how well this imaging technique can detect cancer that has spread to the pelvic lymph nodes, which are small glands that help fight infection.

Participants in the study will receive an injection of a solution called Radelumin, which contains a substance that helps highlight areas of cancer during the PET/CT scan. The study will compare the results of the PET/CT scans with the findings from a biopsy, which is a procedure where a small sample of tissue is taken from the body to be examined under a microscope. This comparison will help determine the accuracy of the PET/CT scans in identifying cancer spread.

The study will be conducted over a period of time, during which participants will undergo the PET/CT scan and have their results analyzed by three independent experts who are not aware of the patients' clinical information. This approach ensures an unbiased assessment of the imaging technique's effectiveness. The study aims to provide valuable information that could improve the diagnosis and treatment planning for patients with high-risk prostate cancer.

The research process

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

  1. Step 1

    Initial visit

    Upon joining the study, you will attend an initial visit where the study team will explain the trial process. You will be asked to provide written informed consent, confirming your understanding and willingness to participate.

    During this visit, your medical history will be reviewed, and you will undergo a physical examination to ensure eligibility for the trial.

  2. Step 2

    Pre-trial imaging

    You will undergo conventional imaging tests, such as a CT or MRI scan, and possibly a bone scan if needed. These tests are to check for any spread of cancer to the pelvic lymph nodes or other areas.

  3. Step 3

    PET-CT scan

    You will receive an injection of a solution called Radelumin, which contains a special substance that helps highlight areas of cancer during imaging. The solution is administered as an injectable solution.

    After the injection, you will undergo a PET-CT scan. This scan combines two types of imaging to provide detailed pictures of your prostate and surrounding areas.

  4. Step 4

    Follow-up visit

    After the PET-CT scan, you will have a follow-up visit with the study team. They will discuss the results of your scan and any further steps in your treatment plan.

    The study team will also monitor for any side effects from the injection and address any concerns you may have.

  5. Step 5

    End of trial

    The trial is expected to conclude by March 30, 2025. You will be informed about the overall findings of the study once it is completed.

    Your participation will contribute to understanding the effectiveness of the PET-CT scan in detecting prostate cancer spread.

Who can join the trial?

7 criteria

  • The patient must be a male aged 18 years or older.
  • The patient must be able to understand the information about the trial and must provide written consent to participate.
  • The patient must have newly diagnosed, biopsy-proven prostate cancer that is still located in the prostate area, and surgery to remove the prostate and nearby lymph nodes should be the preferred treatment.
  • The patient must have at least high-risk prostate cancer as defined by specific guidelines. This means having one or more of the following:
    • An overall ISUP grade group of 4 or 5, which is a way to classify the aggressiveness of prostate cancer.
    • A clinical category of T3a or greater, which describes the extent of the cancer.
    • A serum PSA level greater than 20 ng/ml, which is a blood test used to help diagnose prostate cancer.
    • The patient must have had standard imaging tests (like a CT or MRI scan, and a bone scan if needed) to check for cancer spread to the pelvic lymph nodes or other areas within 60 days before the planned PET-CT scan.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with prostate cancer cannot participate.
  • Only male patients are eligible for the study.
  • Patients who are part of a vulnerable population are not eligible. This means individuals who may have limited ability to protect their interests, such as those with certain disabilities or those who are economically disadvantaged.
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Investigated drugs

[18F]PSMA-1007 is a special type of imaging agent used in a PET/CT scan. This agent helps doctors see certain areas of the body more clearly, especially when looking for signs of prostate cancer that might have spread to nearby lymph nodes. The imaging agent works by attaching to a specific protein found on prostate cancer cells, making it easier for doctors to detect cancerous areas during the scan. This helps in diagnosing and planning the best treatment for patients with high-risk prostate cancer.

What is already known about the treatment

[18F]PSMA-1007 – This medication is administered through an injection and is used in PET/CT imaging, a type of scan that helps doctors see inside the body. It is currently being studied for its effectiveness in diagnosing prostate cancer, specifically in patients who are newly diagnosed with high-risk or very-high-risk forms of the disease. The main purpose of this medication is to help detect cancer that has spread to the pelvic lymph nodes. It works by attaching to a protein commonly found on prostate cancer cells, allowing doctors to see these cells more clearly during imaging. This medication is classified as a radiopharmaceutical, which means it is a radioactive compound used for diagnosis or treatment.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. The prostate is a small gland in males that produces seminal fluid. As the disease progresses, it may spread to nearby tissues or other parts of the body, such as the bones and lymph nodes. Early stages often have no symptoms, but as it advances, it can cause difficulty urinating, blood in urine, or pelvic discomfort. The progression can vary, with some forms growing slowly and others being more aggressive. Monitoring and understanding the growth pattern is crucial for managing the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504026-19-01Protocol codeABX-CT-302EU/EAGLE-iEstimated enrolment435 patientsSponsorAbx Advanced Biochemical Compounds - Biomedizinische Forschungsreagenzien GmbH

sourced from the EU Clinical Trials Register and site verification

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