AuthorisedTherapeutic confirmatory (Phase III)Interventional

Higher diagnostic accuracy of 64Cu PET/CT compared to standard 18F-choline PET/CT in the detection rate of metastasis from prostate cancer.

This study is for men with prostate cancer who might be at risk of the cancer spreading to other parts of their body. Researchers want to see if a newer type of scan, called 64Cu PET/CT, is more accurate than the scan currently used, called 18F-choline PET/CT, at finding these cancer spots. Both scans involve injecting a small amount of a special substance into your body to help detect any cancer that has spread. The study will carefully compare both scans in the same patients to see which one is better at identifying where the cancer might be. The goal is to help doctors make more informed decisions about treatment more quickly.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

A.C.O.M. Advanced Center Oncology Macerata S.r.l.

Enrolment target

285

Start

24 Feb 2025

Prostate cancer at risk of developing metastatic lesions

What is this study about?

This research study is looking at ways to detect if prostate cancer has spread to other parts of the body, which doctors call 'metastasis'. If prostate cancer spreads, it can go to areas like bones, lymph nodes (small glands that are part of your immune system), or other organs.

Currently, doctors often use a scan called 18F-choline PET/CT to look for these spread-out cancer cells. In this study, they are comparing this standard scan to a newer type of scan called 64Cu PET/CT. Both scans work by injecting a small amount of a radioactive substance into your body. This substance is attracted to cancer cells, making them light up on the scan image, so doctors can see them.

The main goal of the study is to see which of these two scans is better at finding these cancer spots accurately. They want to know which scan is more 'sensitive' (meaning it can find more of the cancer spots) and more 'specific' (meaning it's good at only lighting up actual cancer and not other things). By finding cancer spread more accurately, doctors can make better and faster decisions about the best treatment plan for individual patients, which is incredibly important for managing prostate cancer effectively.

Key takeaways

Compares two types of scans for prostate cancer spread.
Aims to find which scan is more accurate at detecting cancer that has spread.
Involves men with prostate cancer who are at risk of spread.
Could help doctors make better and quicker treatment decisions.
Both scans involve a small, safe injection of a tracing substance.

Who may be eligible?

This study is looking for men aged 18 or over. You must have prostate cancer and your doctors must think there's a chance the cancer could have spread to other parts of your body. This doesn't necessarily mean it *has* spread, but that your medical situation puts you at risk.

The research team will need to check your medical history and current health carefully to make sure the study is a safe and suitable option for you. This will involve looking at your overall health and any other medical conditions you might have.

If you're a man with prostate cancer and your doctor has mentioned concerns about potential spread, you might be a good fit for this study. The research team will be able to tell you if you meet all the specific requirements.

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?
Are you 18 years old or older?
Have you been diagnosed with prostate cancer?
Has your doctor discussed that your prostate cancer might be at risk of spreading?

Answer every question to see your result.

What does participation involve?

If you join this study, you would have both types of scans being tested: the standard 18F-choline PET/CT scan and the newer 64Cu PET/CT scan. These will happen at different times, and you'll receive a small, safe injection of a tracer substance before each scan.

Beyond the scans, the study will involve regular check-ups and follow-up appointments. These appointments are important for the research team to monitor your health and gather information about your treatment journey. They will also look at your existing medical information, such as your PSA levels (a blood test for prostate cancer).

Details on the exact number of visits, their duration, and the total length of your participation would be explained fully by the study team. They will also assess the impact of these scans on the decisions your doctors make about your care.

Potential risks and benefits

Taking part in this study could potentially benefit you by providing very detailed information about your prostate cancer, which might help your doctors make the best treatment choices. The scans could lead to a more accurate and earlier detection of any cancer spread. As with any medical procedure, there are some potential risks. Both scans involve a small amount of a radioactive substance, but the dose is very low and considered safe. There's a slight risk of an allergic reaction to the injected substance, and you might experience discomfort from the injection itself. You have the right to withdraw from the study at any time, for any reason, without it 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
Italy

Common questions

What is a PET/CT scan?

A PET/CT scan is a type of imaging test that combines two different scans. It helps doctors see how your body's cells are working and also provides detailed pictures of your organs and tissues.

Why are two different scans being compared?

Researchers want to find out if a newer type of scan (64Cu PET/CT) is better than the one currently used (18F-choline PET/CT) at finding if prostate cancer has spread. This helps improve diagnosis.

Will I get both scans if I join?

Yes, if you participate in the study, you will undergo both the 64Cu PET/CT scan and the 18F-choline PET/CT scan so they can be directly compared.

Are the injections safe?

Yes, the injections contain a very small and safe amount of a special substance designed to help show cancer cells on the scan. The research team will explain any potential, rare side effects.

Will this study change my cancer treatment?

The information from these scans *could* help your doctors make more informed decisions about your treatment plan, as they might provide a clearer picture of your cancer.