Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Diagnostic Performance of Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography/Computed Tomography (PET/CT) Imaging for Pre-operative Lymph Node Assessment in Intermediate and High-risk Nonmetastasic Prostate Cancer

This study is investigating how effective a special scan, called a PET-PSMA scan, is at finding prostate cancer cells in the lymph nodes. If you have intermediate or high-risk prostate cancer and are considering surgery to remove the prostate, this scan could help your doctors. By comparing the PET-PSMA scan results with detailed tissue analysis after surgery, researchers aim to understand if this scan provides a clearer picture of where the cancer might have spread. This information is important for doctors to plan the most effective treatment, ensuring that any affected lymph nodes are identified and addressed during surgery, potentially leading to better outcomes for patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Regional Et Universitaire De Brest

Enrolment target

159

Start

26 Nov 2024

Prostate Cancer

What is this study about?

This study is about making sure men with prostate cancer get the best possible treatment. If you have prostate cancer that's considered 'intermediate' or 'high-risk,' it means there's a higher chance the cancer might have spread beyond the prostate itself, particularly to nearby lymph nodes. Lymph nodes are small, bean-shaped glands that are part of your body's immune system.

Currently, doctors use different ways to check for cancer spread. This study is testing a special type of scan called a PET-PSMA scan. The goal is to see if this scan is better at finding cancer in the lymph nodes before surgery compared to current methods. Knowing if cancer has spread to lymph nodes is really important because it helps your medical team decide the best plan for your treatment, especially if you're having surgery to remove your prostate.

By comparing the results of the PET-PSMA scan with what doctors find during and after surgery (when they can look at the tissues very closely), we can learn if this new scan gives more accurate information. This could lead to more tailored and effective treatments for men with prostate cancer in the future.

Key takeaways

This study is testing a new scan for prostate cancer.
It aims to find cancer in lymph nodes before surgery.
This could lead to more precise treatment plans.
Participation involves having an extra scan.
It's for men with intermediate or high-risk prostate cancer.
Your medical care will not be affected if you choose not to join.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older.

This study is for men who have prostate cancer that doctors consider intermediate or high-risk. This means there's a greater chance the cancer could affect nearby areas. Your medical team will have discussed and decided that surgery to remove your prostate (called a prostatectomy) is the right treatment for you.

Both men and women can technically be included in studies, but this particular study focuses on prostate cancer, which only affects men. Your doctors will check if your specific health situation matches all the requirements for this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with intermediate or high-risk prostate cancer?
Is surgery to remove your prostate (prostatectomy) recommended for you?
Are you willing to have a special scan before your surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main thing you'll be doing is having a special scan called a PET-PSMA scan before your planned prostate surgery. This scan involves a small injection of a harmless, temporary substance into your arm. Following your surgery, the medical team will carefully examine the tissues removed to compare with the scan results. We'll also keep an eye on how you're doing after treatment. There might be some follow-up appointments, which may include checking your PSA levels (a blood test for prostate health) and other imaging scans. The total time you'll be involved in the study will depend on your individual treatment and follow-up plan set by your doctors.

Potential risks and benefits

Taking part in this study might offer you the benefit of a more detailed scan (PET-PSMA) that could help your doctors fine-tune your surgical plan. However, as with any medical procedure, there are some potential risks. The PET-PSMA scan involves a small amount of radiation, similar to other commonly used scans, and there's a very small chance of an allergic reaction to the injected substance. Your doctors will discuss all potential risks with you. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is a PET-PSMA scan?

It's a special type of scan that uses a small amount of a radioactive substance to highlight prostate cancer cells, helping doctors see where they are in your body.

Why is this scan being studied?

Doctors want to see if this scan can better find prostate cancer that has spread to lymph nodes before surgery, which could help them plan your treatment more effectively.

Will I still have my surgery if I join?

Yes, this study is for men who are already planning to have prostate removal surgery as part of their treatment.

Is the injection for the scan painful?

The injection is usually given into a vein in your arm, similar to a blood test, so you might feel a brief sting.

How long will I be in the study?

The study involves your pre-surgery scan and follow-up after your surgery. Your doctor will explain the expected duration based on your treatment plan.