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Study on Using Copper (64Cu) Chloride PET/CT Imaging for Prostate Cancer Patients with Biochemical Relapse After Surgery to Guide Radiation Therapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with prostate cancer who have experienced a return of the disease after having their prostate surgically removed. The study is investigating the use of a special imaging technique called PET/CT with a solution known as 64CuCl2 to help identify patients who might benefit from additional treatment with radiation therapy on the area where the prostate used to be, known as the prostatic bed.

The purpose of the study is to evaluate how accurately the 64CuCl2 PET/CT scan can detect the return of prostate cancer in patients who have already had surgery and show signs of the disease coming back, as indicated by rising levels of a protein called PSA in their blood. This imaging method is being tested to see if it can find cancer that other traditional methods might miss. The study involves patients who have had a previous diagnosis of prostate cancer and have undergone surgery to remove the prostate, but now show signs of the disease returning.

Participants in the study will receive an injection of the 64CuCl2 solution, which is a type of imaging agent, and then undergo a PET/CT scan. The results of this scan will help doctors determine if there is a local recurrence of cancer in the prostatic bed. The study will also look at how the scan results might influence treatment decisions, such as whether to proceed with radiation therapy. The trial aims to provide valuable information on the effectiveness of this imaging technique in guiding treatment for patients with recurrent prostate cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The trial begins with an initial assessment to confirm eligibility. This includes verifying age, previous medical history, and recent imaging tests.

    Eligibility criteria include being 45 years or older, having a history of prostate cancer surgery, and showing signs of cancer recurrence through specific blood tests.

  2. Step 2

    Preparation for imaging

    Preparation involves ensuring no other significant health issues are present and confirming the ability to understand and sign the consent form.

    Previous imaging tests such as mpMRI or PET/CT should have been conducted within the last 30 days.

  3. Step 3

    Administration of 64CuCl2

    The patient receives an injection of 64CuCl2 solution. This is a diagnostic agent used to highlight areas of potential cancer recurrence.

    The injection is administered as a solution directly into the bloodstream.

  4. Step 4

    PET/CT imaging

    Following the injection, a PET/CT scan is performed. This imaging technique helps identify areas where cancer may have returned.

    The scan focuses on the prostate bed, the area where the prostate was located before surgery.

  5. Step 5

    Evaluation of imaging results

    The results of the PET/CT scan are analyzed to determine if there is a detectable recurrence of cancer.

    The presence of cancer is indicated by a focal absorption in the prostate bed that is higher than the surrounding area.

  6. Step 6

    Follow-up and monitoring

    Patients are monitored for changes in PSA levels, a marker used to assess prostate cancer activity.

    The trial evaluates the relationship between PSA levels and imaging results to guide further treatment decisions.

  7. Step 7

    Adverse event recording

    Any adverse events experienced during the trial are recorded and classified according to established guidelines.

    This ensures patient safety and helps refine the use of the diagnostic agent.

Who can join the trial?

13 criteria

  • Must be a male aged 45 years or older at the time of joining the study.
  • Must have had a recent imaging test called mpMRI (a special type of MRI scan) or an ultrasound within the last 30 days.
  • Must have a Karnofski Index of 80% or higher, which means being able to carry out normal activities and work with some effort.
  • Must not have any other significant health problems that could affect participation.
  • Must be able to fully understand and sign the consent form, which explains the study details.
  • Must have a previous confirmed diagnosis of a type of prostate cancer called primitive prostate adenocarcinoma.
  • Must have had surgery to remove the prostate, known as a radical prostatectomy.
  • Must have had a drop to zero in PSA levels, which is a blood test used to measure prostate health.
  • Must have a documented increase in PSA levels, indicating a possible return of cancer, with two tests showing values between 0.2 ng/ml and 1 ng/ml.
  • Must not have any cancer spread to other parts of the body that was not seen in previous imaging tests like mpMRI or PET/CT scans.
  • Must not have a history of other cancers, except for non-melanoma skin cancer.
  • Must have had a recent 18F-FCH PET or PSMA PET scan within the last 30 days, which are special imaging tests for prostate cancer.
  • Must be planned to receive salvage radiotherapy, which is a type of radiation treatment, to the area where the prostate was located.

Who cannot join the trial?

3 criteria

  • Only male patients can participate. Female patients are excluded.
  • Patients who are not within the specified age range are excluded. The age range is not specified here, but it is important to check if you fall within the eligible age group.
  • Patients who are part of a vulnerable population are excluded. This means people who might need special protection or care, like those with certain disabilities or conditions.
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Investigated drugs

64CuCl2 is a special imaging agent used in PET/CT scans. In this trial, it helps doctors see if prostate cancer has come back in patients who have had their prostate removed. This imaging agent is used when other traditional methods do not show clear results. It helps in deciding if further treatment, like radiotherapy, is needed.

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 in clinical trials to assess its effectiveness in detecting prostate cancer recurrence after prostatectomy. The main therapeutic indication is for patients with biochemical relapse of prostate cancer, specifically targeting the prostatic bed. At the molecular level, 64CuCl2 works by emitting positrons that are detected by the PET scanner, providing detailed images of cancerous tissues. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often progresses slowly and may not show symptoms in the early stages. As it advances, it can cause urinary problems, pelvic discomfort, or erectile dysfunction. The cancer can spread to nearby tissues or other parts of the body, such as bones or lymph nodes. Monitoring PSA levels is crucial in assessing the progression of the disease. Early detection and monitoring are key to managing its progression effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520868-17-00Protocol codeP.64Cu.002.02Estimated enrolment138 patientsSponsorA.C.O.M. Advanced Center Oncology Macerata S.r.l.

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