Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Multicenter, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging of Men with Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy with Pelvic Lymph Node Dissection

This study, known as a Phase 3 trial, is investigating how accurately a specific type of scan, called a Copper-64 PSMA PET/CT scan, can detect if prostate cancer has spread to lymph nodes in the pelvis. The study is for men who have been recently diagnosed with more advanced prostate cancer (unfavourable intermediate, high-risk, or very high-risk) and are planning to have surgery to remove their prostate and some lymph nodes. Researchers want to compare the scan results with what doctors find when they examine the removed lymph nodes under a microscope. This comparison will help determine how good the scan is at identifying when cancer *is* present in the lymph nodes, and when it *isn't*. The goal is to provide doctors with better tools to stage prostate cancer, which helps in planning the best treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Curium US LLC

Enrolment target

150

Start

15 Jan 2025

Prostate cancer

What is this study about?

When someone is diagnosed with prostate cancer, it's really important for doctors to know if the cancer is just in the prostate or if it has spread to other parts of the body, especially nearby lymph nodes. This helps them decide the best way to treat it. Currently, doctors use different tests to figure this out, but sometimes it can be hard to tell precisely.

This study is looking at a new type of scan called a Copper-64 PSMA PET/CT scan. This scan uses a small, safe amount of a special substance (called a tracer) that attaches to prostate cancer cells, making them show up brightly on the scan. The main purpose of this study is to see how accurate this scan is at finding prostate cancer cells in the lymph nodes in the pelvis, compared to what doctors find when they remove these lymph nodes during surgery and look at them closely under a microscope.

So, think of it as testing a new advanced 'map' to see how well it shows where prostate cancer has spread. If this scan proves to be very accurate, it could help doctors get a clearer picture of the cancer's stage before surgery, leading to more tailored and effective treatment plans for men with prostate cancer.

Key takeaways

This study is testing a new type of advanced scan for prostate cancer.
It aims to see how well the scan finds prostate cancer in lymph nodes before surgery.
The study is for men with specific types of prostate cancer who are having surgery.
It compares scan results with what's found in the lab after surgery.
The goal is to help doctors better stage prostate cancer and plan treatments.
Participation involves the scan and brief monitoring after the injection.

Who may be eligible?

This study is open to men who are at least 18 years old.

To be considered for this study, you must have been recently diagnosed with certain types of prostate cancer that are considered more serious (unfavourable intermediate-risk, high-risk, or very high-risk). You also need to be planning to have an operation to remove your prostate, which would also involve taking out some of the lymph nodes from your pelvis.

There might be other specific health requirements or conditions that would mean you can or cannot join the study, so it's always best to discuss your situation with your doctor.

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 a man aged 18 or over?
Have you recently been diagnosed with unfavourable intermediate-risk, high-risk, or very high-risk prostate cancer?
Are you planning to have surgery to remove your prostate and some pelvic lymph nodes?
Are you able to attend appointments for the scan and follow-up?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would essentially be undergoing the special Copper-64 PSMA PET/CT scan. This scan will happen shortly before your planned prostate and lymph node surgery. You will be given a small injection of the special tracer, and then you'll have the scan. After the scan, doctors will carry out your surgery as planned. The main part of the study involves comparing the results of your scan with what is found in the lymph nodes removed during your surgery when they are examined in the lab. This comparison will help the researchers understand how well the scan works. You would also be monitored for any side effects from the injection for a short time after you receive it. The total duration of your active participation in the study from the injection to a follow-up check-up shouldn't be very long.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as contributing valuable information that could improve how prostate cancer is diagnosed and treated for future patients. For you personally, the scan might provide additional information about your cancer that could be helpful to your doctors. However, there are also potential risks, such as side effects from the injection of the tracer, although these are generally mild and temporary. As with any medical procedure, there's a small risk of discomfort or allergic reaction. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

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

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Unverified
France
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Unverified
Spain
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Unverified
Italy

Common questions

What is a PET/CT scan?

A PET/CT scan is a medical imaging test that combines two types of scans: a PET scan (Positron Emission Tomography) which shows the activity of cells, and a CT scan (Computed Tomography) which takes detailed X-rays. Together, they create detailed pictures of the inside of your body.

What is 'Copper-64 PSMA I&T'?

This is a special substance, also called a 'tracer', that is injected into your body for the PET/CT scan. It's designed to attach specifically to prostate cancer cells, making them light up on the scan and helping doctors see where the cancer might be.

What are 'lymph nodes'?

Lymph nodes are small, bean-shaped glands that are part of your body's immune system. They can sometimes be where cancer cells spread first, especially in the pelvis for prostate cancer.

What does 'unfavourable intermediate-risk, high-risk or very high-risk' prostate cancer mean?

These terms are used by doctors to describe how likely the prostate cancer is to grow quickly or spread. Higher risk categories mean the cancer is more aggressive and needs more careful treatment planning.

Will this study change my planned surgery?

The study is designed to assess the scan's accuracy against what is found during your planned surgery. Your surgery itself would proceed as your doctors have already planned, regardless of the study. The study aims to provide additional information that may be useful for future patients.