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Evaluation of PSMA PET/CT Imaging for Lymph Node Assessment in Patients with Intermediate and High-Risk Non-Metastatic Prostate Cancer Before Surgery

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 study focuses on patients with Prostate Cancer who are scheduled for surgical removal of the prostate. The study will use two imaging agents: 68GA-PSMA and Locametz, which are special substances that help detect cancer cells during scanning. These substances are given through an intravenous injection before performing detailed body scans.

The purpose of this research is to determine how well a special type of imaging called Positron Emission Tomography (combined with Computed Tomography) can detect whether cancer has spread to lymph nodes in patients with intermediate or high-risk prostate cancer. This imaging technique uses a substance that specifically attaches to prostate cancer cells, making them visible during the scan.

During the study, participants will receive an injection of the imaging agent and undergo a scanning procedure. The results of these scans will be compared with findings from surgery and other standard tests. The imaging will help doctors determine if cancer cells have spread beyond the prostate, which is important information for planning surgery and other treatments.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial PET-PSMA scan

    You will receive an intravenous injection of a special imaging substance called 68GA-PSMA

    A combined PET/CT scan (imaging that shows both body structure and cell activity) will be performed to examine lymph nodes

    This examination helps determine if cancer has spread to lymph nodes

  2. Step 2

    Surgical procedure

    Based on imaging results, you will undergo a total prostatectomy (complete removal of the prostate)

    During surgery, doctors will also remove lymph nodes for examination

    The surgery plan may be adjusted based on the PET-PSMA scan results

  3. Step 3

    Follow-up period

    Regular monitoring of PSA levels (prostate-specific antigen blood test) will be conducted

    Additional imaging tests may be performed if needed

    Your progress will be monitored until May 2027

  4. Step 4

    Safety monitoring

    Any unexpected health changes or side effects will be recorded throughout the study

    Regular medical check-ups will be scheduled to monitor your health

Who can join the trial?

11 criteria

  • Must be at least 18 years old
  • Must have confirmed prostate cancer through tissue examination (histological confirmation)
  • Must have either:
    • Intermediate-risk prostate cancer with:
      • PSA blood test results between 10 and 20 ng/mL, and/or
      • Cancer that can be felt during examination (T2b stage), and/or
      • ISUP grade 2 or 3 cancer cells
      • More than 5% risk of cancer spreading to lymph nodes
      • OR high-risk prostate cancer with:
        • PSA blood test results of 20 ng/mL or higher, and/or
        • Cancer that has spread within the prostate (T2c stage or higher), and/or
        • ISUP grade 4 or 5 cancer cells
        • Must be scheduled for complete surgical removal of the prostate (total prostatectomy) as recommended by a team of medical specialists
        • Must have valid health insurance coverage

Who cannot join the trial?

12 criteria

  • Age below 18 years or above 65 years
  • Previous treatment for prostate cancer (such as surgery, radiation therapy, or hormone therapy)
  • Presence of distant metastases (cancer spread to distant organs)
  • Known allergies to PSMA ligands (substances used in PET imaging)
  • Inability to lie still for the duration of the PET scan (approximately 30 minutes)
  • Current participation in other clinical trials
  • Severe kidney dysfunction (as it may affect the imaging agent elimination)
  • Conditions that would prevent having surgery
  • Previous pelvic surgery that could affect lymph node evaluation
  • Psychiatric or other conditions that could affect the ability to provide informed consent
  • Contraindications to PET imaging (such as inability to lie flat or claustrophobia)
  • Pregnancy or breastfeeding
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Investigated drugs

Based on the provided trial data, there is one diagnostic imaging agent used in this study: PSMA PET imaging agent - This is a radioactive tracer used in PET/CT scans that specifically binds to prostate-specific membrane antigen (PSMA). This substance helps doctors see if prostate cancer has spread to lymph nodes. When injected into the body, it attaches to prostate cancer cells, making them visible on PET/CT imaging. This allows doctors to detect potential cancer spread before surgery in patients with intermediate or high-risk prostate cancer.

What is already known about the treatment

68Ga-PSMA - A radioactive diagnostic agent administered intravenously for Positron Emission Tomography (PET/CT) imaging, specifically designed to detect prostate cancer cells and their potential spread to lymph nodes. This tracer works by binding to Prostate Specific Membrane Antigen (PSMA), a protein that is highly expressed on the surface of prostate cancer cells, allowing for precise visualization of cancer locations in the body. The substance is classified as a radiopharmaceutical diagnostic agent and is particularly valuable in determining the extent of prostate cancer spread before surgery, helping doctors make more informed decisions about treatment plans.

Investigated diseases

Prostate Cancer - A disease that begins in the prostate gland, which is part of the male reproductive system. The condition typically develops slowly, starting from normal prostate cells that gradually change and grow uncontrollably, forming a tumor. Most prostate cancers start in the gland cells (adenocarcinomas). As the disease progresses, cancer cells may spread to nearby lymph nodes and can eventually reach other parts of the body. The condition mainly affects older men and becomes more common with advancing age. Early stages of prostate cancer often develop without noticeable symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516319-25-00Protocol code29BRC20.0203Estimated enrolment159 patientsSponsorCentre Hospitalier Regional Et Universitaire De Brest

sourced from the EU Clinical Trials Register and site verification

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