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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 study about?

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.

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 consent and information

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

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Ente Ospedaliero Ospedali Galliera Di Genova Genoa Italy
Icbemd Idpthkbg Fiptbysyegeqk Oqowvttoxvh Rome Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not yet recruiting
23.06.2019

Trial locations

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.

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 ID:
2025-520861-29-00
Protocol code:
P.64Cu.003.01
Trial Phase:
Therapeutic confirmatory (Phase III)

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