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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Centr Georges Francois Leclerc Dijon France
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario Hm Sanchinarro Madrid Spain
Centre Jean Perrin Clermont Ferrand France
Hospital Universitario De Salamanca Salamanca Spain
Oncopole Claudius Regaud Toulouse France
Hospital Universitario De Navarra Pamplona Spain
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Centre Hospitalier Universitaire De Nimes Nimes France
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Hospital Universitario De Toledo Ute Toledo Spain
Hospital Universitario Clínico San Cecilio Granada Spain
Hospital Universitario Reina Sofía Cordoba Spain
Virgen del Rocío University Hospital Sevilla Spain
Ente Ospedaliero Ospedali Galliera Di Genova Genoa Italy
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hopital Beaujon Clichy France
Clinique Victor Hugo Le Mans France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Groupement Des Hopitaux De L’Institut Catholique De Lille lomme France
Centre Hospital Region Metz Thionville Metz France
Holhqutz Ukcgizxddcxlo Mzewpti Dm Voacjdjnwu Santander Spain
Hxcdlybh Ukwbbebogmosb Rfoaohxm Du Mtxxyz Malaga Spain
Cwck Dg Nlqhg Vandoeuvre Les Nancy France
Aydltsp Oyxkywsgfnn Puhg Gqzqgepd Xfdoi Bergamo Italy
Izchugno Pcuekksqnsyxcpf Ciogbk Cxlbcf Marseille France

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

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
15.10.2024
Italy Italy
Not yet recruiting
15.10.2024
Spain Spain
Not yet recruiting
15.10.2024

Trial locations

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.

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 ID:
2024-512754-16-00
Protocol code:
CURCu64PSM0003
Trial Phase:
Therapeutic confirmatory (Phase III)

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