Not recruiting

Study on the Use of 18F-PSMA-1007, Piflufolastat (18F), and Gozetotide for Detecting Pelvic Lymph Node Invasion in Newly Diagnosed Prostate Cancer Patients

Verified siteRegistered drugNo 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 evaluating the effectiveness of a special imaging technique called Prostate-Specific Membrane Antigen Positron Emission Computer Tomography (PSMA PET/CT) in detecting the spread of Prostate Cancer to the pelvic lymph nodes. The study aims to determine if using PSMA PET/CT can help reduce the number of surgical procedures called extended pelvic lymph node dissections (ePLND) that are currently performed on patients with newly diagnosed prostate cancer. The goal is to see if this approach can lower healthcare costs and reduce the burden on patients while maintaining similar outcomes in terms of disease progression.

The study involves three different treatments: 18F-PSMA-1007, PIFLUFOLASTAT (18F), and Locametz 25 micrograms kit for radiopharmaceutical preparation. These are solutions that are injected into the body to help highlight cancer cells during the PSMA PET/CT scan. The trial will compare the results of using these imaging agents with the current standard practice, which involves performing ePLND based on a calculated risk of cancer spread. The study will monitor various outcomes, including the rate of cancer returning after surgery and any complications related to the procedures.

Participants in the study will undergo PSMA PET/CT scans and may receive one of the imaging agents through an intravenous injection. The trial will track the number of surgical procedures performed, the costs associated with these interventions, and any complications that arise. The study will also assess the number of lymph nodes removed during surgery and whether additional PSMA PET/CT scans are needed. The trial is expected to continue until June 2030, with the aim of providing valuable insights into the cost-effectiveness and patient impact of using PSMA PET/CT in the management of prostate cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
The study begins with an initial assessment to confirm eligibility. This includes verifying age, diagnosis of prostate cancer, and suitability for specific procedures.
Eligibility criteria include being 18 years or older, having a biopsy-proven adenocarcinoma of the prostate, and being suitable for robot-assisted extended pelvic lymph node dissection (ePLND) combined with robot-assisted radical prostatectomy (RARP).
Step 2
Informed consent
Participants must provide written informed consent after understanding the potential benefits and burdens of the study.
Step 3
Psma pet/ct scan
A PSMA PET/CT scan is performed to detect pelvic lymph node invasion. This scan uses a special imaging technique to help visualize prostate cancer spread.
The scan involves the use of a radiopharmaceutical solution, such as 18F-PSMA-1007, administered through an intravenous injection.
Step 4
Surgical procedure
Based on the results of the PSMA PET/CT scan, a decision is made regarding the necessity of performing an extended pelvic lymph node dissection (ePLND) during the robot-assisted radical prostatectomy (RARP).
The goal is to reduce unnecessary surgical procedures and associated complications.
Step 5
Post-surgery follow-up
After surgery, follow-up assessments are conducted to monitor recovery and check for any surgical complications within six months.
Biochemical recurrence is evaluated by measuring prostate-specific antigen (PSA) levels, with a focus on detecting any increase above 0.2 ng/ml within two years post-surgery.
Step 6
Evaluation of outcomes
The study evaluates the cost-effectiveness of using PSMA PET/CT as a selection tool for ePLND, comparing it to standard practices.
Outcomes include the total number of ePLNDs and PSMA PET/CTs performed, healthcare costs, and the necessity for a second PSMA PET/CT.

Who can join the trial?

6 criteria

Must be at least 18 years old.
Must have a confirmed diagnosis of prostate cancer through a biopsy. A biopsy is a procedure where a small sample of tissue is taken from the body to be examined.
Must need a procedure called **extended pelvic lymph node dissection (ePLND)** along with **robot-assisted radical prostatectomy (RARP)**. ePLND is a surgery to remove lymph nodes in the pelvic area, and RARP is a type of surgery to remove the prostate using robotic assistance.
Must be suitable for the combined robot-assisted ePLND and RARP procedures.
Must be mentally capable of understanding the benefits and potential challenges of participating in the study.
Must provide written informed consent, which means agreeing in writing to participate in the study after being informed about it.

Who cannot join the trial?

2 criteria

Only male patients can participate. Female patients are not eligible.
Patients who are considered part of a vulnerable population cannot participate. This means people who might need extra protection or care, like those with certain disabilities or those who cannot make decisions for themselves.

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Verified sites

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

Amphia Hospital
Verified
Breda, The Netherlands
Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Catharina Ziekenhuis Stichting
Verified
Eindhoven, The Netherlands

Trial locations

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Investigated drugs

PSMA PET/CT is an imaging technique used to detect prostate cancer spread to the pelvic lymph nodes. It helps doctors decide if a surgical procedure called extended pelvic lymph node dissection (ePLND) is necessary. This method aims to reduce the number of unnecessary surgeries, lower healthcare costs, and decrease the risk of complications for patients, while maintaining effective disease management.

What is already known about the treatment

PSMA-PET/CT – This is a diagnostic imaging method used in the evaluation of prostate cancer. It involves the administration of a radioactive tracer that binds to the Prostate-Specific Membrane Antigen (PSMA) on prostate cancer cells, allowing for detailed imaging through Positron Emission Tomography/Computed Tomography (PET/CT). Currently, it is being studied for its effectiveness in detecting pelvic lymph node invasion in newly diagnosed prostate cancer patients. The main therapeutic indication is to assist in the staging of prostate cancer, potentially reducing the need for invasive procedures. The mechanism of action involves the tracer binding to PSMA, which is overexpressed in prostate cancer cells, allowing for precise imaging. It is classified under diagnostic radiopharmaceuticals.

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. As the disease progresses, it may spread to nearby tissues or other parts of the body. Early stages often show no symptoms, but advanced stages can lead to difficulties in urination, blood in urine, or pelvic discomfort. The progression can vary, with some cases growing slowly and others more aggressively. Monitoring and regular check-ups are crucial to understanding its development.