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Study on the Use of 64Cu-PSMA I&T to Detect Lymph Node Spread in Men with Newly Diagnosed Prostate Cancer Before Surgery

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 studying Prostate Cancer, a condition where cells in the prostate gland grow uncontrollably. The study is investigating a new diagnostic method using a special imaging agent called Copper Cu 64 PSMA I&T. This agent is used in a type of scan known as PET/CT, which helps doctors see if the cancer has spread to the lymph nodes in the pelvis. The purpose of the study is to determine how well this imaging agent can detect the presence or absence of cancer in these lymph nodes in men who have been newly diagnosed with prostate cancer and are planning to undergo surgery to remove the prostate and some surrounding lymph nodes.

Participants in the study will receive an injection of the Copper Cu 64 PSMA I&T solution, which is administered through an intravenous injection. After the injection, a PET/CT scan will be performed to capture detailed images of the pelvic area. The study aims to compare these images with the results from the surgery to see if the scan accurately identifies cancerous lymph nodes. This will help determine the effectiveness of the Copper Cu 64 PSMA I&T scan in staging prostate cancer.

The study will also monitor any side effects that may occur from the time the imaging agent is given until 72 hours afterward. The results of this study could provide valuable information on whether this new scanning method can improve the detection of prostate cancer spread, potentially leading to better treatment planning for patients. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of prostate cancer and a planned prostatectomy with pelvic lymph node dissection.

    Participants must be male, aged 18 years or older, and able to provide informed consent.

  2. Step 2

    Preparation for the scan

    Before the scan, participants receive an intravenous injection of 64Cu-PSMA I&T, a solution used to help detect cancer spread.

    This preparation is crucial for the upcoming imaging procedure.

  3. Step 3

    PET/CT scan

    A PET/CT scan is conducted to assess the presence or absence of cancer in the pelvic lymph nodes.

    The scan uses the injected 64Cu-PSMA I&T to provide detailed images for evaluation.

  4. Step 4

    Post-scan evaluation

    After the scan, results are analyzed to determine the presence of metastatic lymph nodes.

    The accuracy of the scan is compared to histopathology results obtained during surgery.

  5. Step 5

    Monitoring for side effects

    Participants are monitored for any side effects from the injection for up to 72 hours after administration.

    This monitoring ensures participant safety and helps identify any treatment-emergent adverse events.

Who can join the trial?

5 criteria

  • Patients must have a confirmed diagnosis of **prostate adenocarcinoma**, which is a type of prostate cancer.
  • Patients should have a planned **prostatectomy**, which is a surgery to remove the prostate gland, along with a **pelvic lymph node dissection**, which is a procedure to remove lymph nodes in the pelvic area.
  • Patients must have **unfavorable intermediate-risk, high-risk, or very high-risk disease** as defined by specific medical guidelines.
  • Participants must be male and at least 18 years old.
  • Participants must be able to understand the study and provide signed written consent, which means they agree to participate after being informed about the study details.

Who cannot join the trial?

4 criteria

  • Patients who do not have prostate cancer cannot participate.
  • Patients who are not male cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

Copper Cu 64 PSMA I&T is a special imaging agent used in PET/CT scans. It helps doctors see if prostate cancer has spread to the pelvic lymph nodes. This is important for planning the best treatment for patients with prostate cancer who are going to have surgery to remove the prostate and nearby lymph nodes.

What is already known about the treatment

Copper Cu 64 PSMA I&T – This medication is administered through a PET/CT scan, where it is used as a diagnostic agent. It is currently being studied in clinical trials for its effectiveness in staging prostate cancer, particularly in patients with newly diagnosed intermediate to very high-risk cases. The main therapeutic indication is to detect pelvic lymph node metastasis in prostate cancer patients before they undergo surgery. At the molecular level, Copper Cu 64 PSMA I&T binds to the Prostate-Specific Membrane Antigen (PSMA) on prostate cancer cells, allowing for precise imaging. It is classified as a radiopharmaceutical diagnostic agent.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. The prostate is a small gland in men that produces seminal fluid. This type of cancer is one of the most common in men and often grows slowly. In some cases, it may spread to nearby tissues or other parts of the body, such as the bones or lymph nodes. Symptoms can include difficulty urinating, blood in the urine, or pelvic discomfort. The progression of the disease can vary, with some cases remaining localized and others becoming more aggressive.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512754-16-00Protocol codeCURCu64PSM0003Estimated enrolment323 patientsSponsorCurium US LLC

sourced from the EU Clinical Trials Register and site verification

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