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Comparing Copper (64Cu) Chloride PET/CT and Fluorocholine (18F) PET/CT for Detecting Metastasis in Prostate Cancer Patients at Risk

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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 cancer cells form in the tissues of the prostate. The study aims to compare two different imaging methods to detect the spread of cancer, known as metastasis. The two methods being compared are 64CuCl2 PET/CT and 18F-choline PET/CT. These are advanced imaging techniques that help doctors see if and where the cancer has spread in the body.

The purpose of the study is to determine which imaging method is more accurate in identifying cancer spread. Participants will undergo both imaging tests. The 64CuCl2 solution for injection and Fluorocholine (18F) solution for injection are used in these tests to help highlight areas of potential cancer spread. The study will assess how well each method detects cancer in different parts of the body, such as bones, lymph nodes, and other organs.

Throughout the study, the impact of these imaging tests on treatment decisions will be evaluated. This includes understanding how the results might change the course of treatment for patients. The study will also look at how these imaging methods relate to levels of a protein called PSA, which is often higher in men with prostate cancer. The goal is to improve the accuracy of cancer detection and help guide better treatment decisions for those with prostate cancer.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and ensuring the absence of other neoplastic diseases, except for non-melanoma skin carcinomas.

    Eligibility criteria include being 45 years or older, having a previous diagnosis of prostate adenocarcinoma, and being at risk of developing metastasis.

  2. Step 2

    Consent and information

    Participants must fully understand and sign an informed consent form. This confirms comprehension of the study's purpose and procedures.

  3. Step 3

    Imaging examination

    Participants undergo imaging examinations such as MRI, CT, bone scans, or PET scans to assess the current state of prostate cancer and potential metastasis.

  4. Step 4

    Administration of 18F-choline

    Participants receive an injection of 18F-choline solution for PET/CT imaging. This helps in detecting cancerous lesions.

    The dosage is 225 MBq/mL, administered as a solution for injection.

  5. Step 5

    18F-choline PET/CT scan

    A PET/CT scan is performed using the 18F-choline to identify any areas of cancer spread. The scan evaluates the presence of metastasis in bones, lymph nodes, and other regions.

  6. Step 6

    Administration of 64CuCl2

    Participants receive an injection of 64CuCl2 solution for PET/CT imaging. This is another method to detect cancerous lesions.

    The solution is administered via injection.

  7. Step 7

    64CuCl2 PET/CT scan

    A PET/CT scan is conducted using the 64CuCl2 to compare its effectiveness against the 18F-choline scan in detecting metastasis.

    The scan results are evaluated for sensitivity and specificity in identifying cancer spread.

  8. Step 8

    Data analysis and follow-up

    The diagnostic performance of both PET/CT scans is analyzed. This includes assessing sensitivity, specificity, and the impact on clinical decision-making.

    Participants are classified based on the extent of metastasis: non-metastatic, oligometastatic (up to three metastases), or multimetastatic.

    Follow-up data is collected to evaluate the impact of the scans on clinical outcomes and any potential misdiagnosis consequences.

Who can join the trial?

13 criteria

  • Must be a male aged 45 years or older at the time of joining the study.
  • Must be able to fully understand and sign a document that gives permission to participate in the study, known as an informed consent.
  • Must have a previous confirmed diagnosis of a type of prostate cancer called primary prostate adenocarcinoma.
  • Must have a medical reason for needing imaging tests to check the stage of the cancer or to re-evaluate it.
  • Must have undergone imaging tests like MRI, TAC, Bone Scan, PET, or other similar tests.
  • Must be at risk of the cancer spreading based on symptoms or specific risk criteria, which include:
  • Class A: High-risk patients before initial treatment, with specific test results like PSA > 20, GS > 7, or certain cancer stages. Must not have started radiotherapy yet.
  • Class B: Patients being re-evaluated after initial treatment, with specific PSA test results.
  • Class C: Patients showing signs of cancer progression during treatment, with specific increases in PSA levels.
  • Must not have a history of other cancers, except for non-melanoma skin cancers.
  • Must have a Karnofski index of 80% or higher, which is a measure of the ability to carry out daily activities.
  • Must not have other significant health issues that would prevent participation in the study.
  • Must fully understand the information provided in the study documents.

Who cannot join the trial?

3 criteria

  • Only male patients can participate in the study. Female patients are excluded.
  • Patients who are not within the specified age range are excluded. The study is for certain age groups only.
  • Patients who are considered part of a vulnerable population are excluded. This means people who might need special protection or care.
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Investigated drugs

  • 64CuCl2 PET/CT

    is a type of imaging test used in this study to detect the spread of prostate cancer. It uses a special radioactive substance, copper-64, which helps to create detailed images of the body. This test is being evaluated for its ability to accurately identify cancerous areas compared to another imaging method.

  • 18F-choline PET/CT

    is another imaging test used in the study for detecting prostate cancer metastasis. It involves a radioactive substance, fluorine-18 choline, which helps to highlight cancerous tissues in the body. This test is the standard method being compared to the new 64CuCl2 PET/CT to see which one is more effective in identifying cancer spread.

What is already known about the treatment

  • 64CuCl2

    This medication is administered through a PET/CT scan, where it is used as a diagnostic imaging agent. It is currently being studied for its effectiveness in detecting metastasis in prostate cancer patients, particularly those at risk of developing metastatic lesions. The main therapeutic indication is to improve the accuracy of diagnosing metastatic prostate cancer. At the molecular level, 64CuCl2 works by emitting positrons that are detected by the PET/CT scanner, providing detailed images of cancerous tissues. It is classified as a radiopharmaceutical used in diagnostic imaging.

  • 18F-choline

    This medication is also administered via a PET/CT scan and serves as a diagnostic imaging agent. It is commonly used in medical practice to detect prostate cancer metastasis. The primary therapeutic indication is to identify cancer spread in patients with prostate cancer. The mechanism of action involves the uptake of 18F-choline by cancer cells, which is then visualized by the PET/CT scanner. It belongs to the pharmacological class of radiopharmaceuticals used for diagnostic purposes.

Investigated diseases

Prostate Cancer at Risk of Developing Metastatic Lesions – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. When at risk of developing metastatic lesions, the cancer has the potential to spread beyond the prostate to other parts of the body. This progression often involves the cancer cells moving to nearby lymph nodes, bones, or other organs. The spread of cancer cells can lead to the formation of new tumors in these areas, known as metastases. The risk of metastasis is a significant concern as it can complicate the management of the disease. Monitoring and imaging techniques are crucial in assessing the spread and impact of the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520861-29-00Protocol codeP.64Cu.003.01Estimated enrolment285 patientsSponsorA.C.O.M. Advanced Center Oncology Macerata S.r.l.

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