Not recruiting

Study on Imaging-Guided Surgery for Prostate Cancer Patients Using [68Ga]PSMA-HBED-CC and [99mTc]PSMA I&S

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 improving the detection of lymph node metastases in patients with prostate cancer who are undergoing surgical treatment. The study involves the use of two imaging agents, [68GA]PSMA-HBED-CC and [99mTc]PSMA I&S, which are administered through an injection. These agents help in guiding the surgery to better identify cancerous lymph nodes during a procedure called robot-assisted radical prostatectomy, which is a type of surgery to remove the prostate gland and some surrounding tissue.

The purpose of the study is to enhance the ability of doctors to detect lymph node involvement in prostate cancer patients who are at risk of cancer spreading to the lymph nodes. This is particularly important for patients who have a higher than 5% risk of lymph node invasion based on preoperative data. The study aims to assess how well the imaging agent [99mTc]PSMA I&S works in this setting.

Participants in the study will receive the imaging agents before their surgery. The surgery will then be guided by the images produced, helping surgeons to identify and remove affected lymph nodes more accurately. The results of the lymph node examination are typically available about 10 days after the surgery. This approach is expected to improve the outcomes of the surgery by ensuring that all cancerous lymph nodes are identified and removed.

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
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis, and planned surgical treatment.
Informed consent is required to participate in the study.
Step 2
Pre-surgery imaging
An imaging procedure is conducted using [68GA]PSMA-HBED-CC administered through an intravenous injection or infusion.
This imaging helps in identifying areas of interest before surgery.
Step 3
Surgical procedure
The surgical procedure involves a robot-assisted radical prostatectomy and extended pelvic lymph node dissection.
During surgery, [99mTc]PSMA I&S is used to guide the detection of lymph nodes.
Step 4
Post-surgery evaluation
After surgery, a histopathological evaluation of the lymph nodes is performed by specialized pathologists.
Results from this evaluation are typically available 10 days after surgery.
Step 5
Follow-up
Regular follow-up appointments are scheduled to monitor recovery and assess any further treatment needs.

Who can join the trial?

6 criteria

Must be a male patient.
Age should be between 18 and 80 years.
Must have a confirmed diagnosis of prostate cancer through a biopsy.
Must have a risk of lymph node invasion greater than 5% based on the Briganti nomogram, which is a tool used by doctors to estimate the risk of cancer spreading to the lymph nodes.
Should be scheduled to have a robot-assisted radical prostatectomy (RARP), which is a type of surgery to remove the prostate, along with an extended pelvic lymph node dissection (ePLND), which is a procedure to remove lymph nodes in the pelvic area.
Must be able to understand and willing to sign a written informed consent document, which means agreeing to participate in the study after being informed about all the details.

Who cannot join the trial?

5 criteria

Patients who do not have prostate cancer.
Patients who are not candidates for surgical treatment with robot-assisted radical prostatectomy. This is a type of surgery to remove the prostate using robotic assistance.
Patients with a risk of lymph nodal invasion of 5% or less. Lymph nodal invasion means cancer has spread to the lymph nodes.
Female patients, as the study is only for male patients.
Patients who are considered part of a vulnerable population. This means groups of people who might need special protection or care.

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Verified sites

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Verified
Ospedale San Raffaele S.r.l.
Milan, Italy

Trial locations

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Investigated drugs

99mTc-PSMA-I&S is a special imaging agent used in this clinical trial. It helps doctors see lymph nodes more clearly during surgery for prostate cancer. This can improve the detection of cancer spread to the lymph nodes, which is important for planning the best treatment approach.

What is already known about the treatment

99mTc-PSMA-I&S – This medication is administered through injection and is used in imaging procedures. It is currently being studied in clinical trials to enhance the detection of lymph node metastases in prostate cancer patients undergoing surgery. The main therapeutic indication is to assist in identifying lymph node involvement in prostate cancer. At the molecular level, it targets the prostate-specific membrane antigen (PSMA), which is often overexpressed in prostate cancer cells, allowing for precise imaging. It is classified as a radiopharmaceutical agent used in nuclear medicine.

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 lead to difficulties in urination, blood in urine, or pelvic discomfort. The cancer can spread to nearby tissues or lymph nodes, and in some cases, to distant parts of the body. The risk of lymph node invasion increases with certain preoperative factors. Early detection and monitoring are crucial for managing its progression.