Not recruiting

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 disease that affects the prostate gland in men. The study will use a special imaging technique involving a substance called 64Cu-PSMA I&T, which is a solution for injection. This substance helps in detecting the spread of cancer to the lymph nodes, which are small glands that are part of the immune system.

The purpose of the study is to evaluate how well the 64Cu-PSMA I&T PET/CT scan can identify whether prostate cancer has spread to the pelvic lymph nodes in men who have been newly diagnosed with unfavorable intermediate-risk, high-risk, or very high-risk prostate cancer. These men are planning to undergo surgery to remove the prostate and some of the surrounding lymph nodes. The study will help determine if the scan can accurately show the presence or absence of cancer in these lymph nodes.

Participants in the study will receive an injection of 64Cu-PSMA I&T and then undergo a PET/CT scan. This scan combines two imaging techniques to provide detailed pictures of the inside of the body. The study will monitor any side effects from the injection for up to 72 hours. The results of the scan will be compared to the findings from the surgery to see how well the scan can detect cancer spread. This research aims to improve the way prostate cancer is staged and treated in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of prostate cancer and ensuring that a prostatectomy with pelvic lymph node dissection is planned.
Eligibility criteria include being male, aged 18 years or older, and having unfavorable intermediate-risk, high-risk, or very high-risk prostate cancer as defined by specific guidelines.
Step 2
Informed consent
Participants are required to understand and provide signed written informed consent before proceeding with the study activities.
Step 3
Administration of <b>64Cu-PSMA I&T</b>
The study involves the administration of 64Cu-PSMA I&T, a solution for injection, given through an intravenous injection. This is a diagnostic agent used to detect potential disease spread to lymph nodes.
Step 4
PET/CT scan
After the administration of 64Cu-PSMA I&T, a PET/CT scan is performed. This scan helps in identifying the presence or absence of metastatic pelvic lymph nodes.
The scan results are compared to a histopathology reference standard to determine the accuracy of the diagnostic performance.
Step 5
Evaluation of results
The sensitivity and specificity of the PET/CT scan are evaluated. Sensitivity refers to the ability to correctly identify patients with metastatic lymph nodes, while specificity refers to correctly identifying those without.
The results are interpreted by independent readers, and any treatment-emergent adverse events are monitored for up to 72 hours after the administration of the investigational product.

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 surgery to remove the prostate, along with a procedure to check the pelvic lymph nodes.
The disease should be classified as unfavorable intermediate-risk, high-risk, or very high-risk according to specific medical guidelines.
Participants must be male and at least 18 years old.
Patients need to be able to understand the study and provide signed written consent, which means they agree to participate after being informed about the study.

Who cannot join the trial?

4 criteria

Only male patients can participate. Female patients are not eligible.
Patients must be within a specific age range. If you are not in the required age group, you cannot participate.
Patients with certain types of prostate cancer are eligible. If your condition does not match the study's requirements, you cannot participate.
Patients who are considered part of a vulnerable population are not eligible. This means people who might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain
Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy

Trial locations

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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.

64CU-PSMA I&T

What is already known about the treatment

Copper Cu 64 PSMA I&T – This medication is administered through an injection and is used in conjunction with PET/CT scans. It is currently being studied in clinical trials for its effectiveness in diagnosing prostate cancer, particularly in assessing the presence of pelvic lymph node metastasis in patients who are about to undergo prostate surgery. The main therapeutic indication is for staging prostate cancer, especially in cases with intermediate to high risk. At the molecular level, it works by binding to the Prostate-Specific Membrane Antigen (PSMA), which is often overexpressed in prostate cancer cells, allowing for better imaging and detection. It falls under the pharmacological classification of radiopharmaceuticals used for diagnostic imaging.

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 cancer often grows slowly and may initially cause no symptoms. As it progresses, it can lead to difficulty urinating, blood in the urine, or pelvic discomfort. In advanced stages, it may spread to nearby lymph nodes or bones. The progression can vary, with some cases remaining localized while others become more aggressive.