Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Multicentre Evaluation of Clinical Applications of Innovative PET/MRI with a 68Ga-PSMA-11 Radiotracer when Planning a Personalised Therapy in Prostate Cancer Patients

This study is exploring a new way to scan for prostate cancer using a combination of PET and MRI technologies, along with a special tracker called 68Ga-PSMA-11. The main goal is to see if these advanced scans can give doctors a better, more accurate picture of prostate cancer, especially in men with intermediate or high-risk disease. This includes understanding if the cancer has spread and whether it has returned after treatment. By getting more precise information, the hope is that doctors can create more personalised and effective treatment plans for each patient. The study will also look at how safe this new scanning method is and how it might change the initial treatment approach.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Medical University Of Bialystok

Enrolment target

366

Start

03 Dec 2024

Intermediate and high-risk prostate cancer

What is this study about?

This research study is looking into a new and advanced way to scan for prostate cancer using a combination of two powerful imaging techniques: PET and MRI. We're also using a special substance, often called a 'dye' or 'tracer,' which helps highlight the cancer cells on these scans. The main purpose is to see if these detailed scans can give doctors a much clearer and more accurate understanding of prostate cancer, especially in men who have a moderate to high risk of their cancer being more serious or spreading.

Imagine your doctor needs to know exactly where the cancer is, if it's spread outside the prostate, or if it has come back after treatment. Traditional scans provide a lot of information, but this new PET/MRI scan, with its special tracer, might offer an even more precise picture. This precision could be really important because it helps doctors decide on the very best, most personal treatment plan for you. The study aims to measure how often this detailed scan changes what doctors understand about the cancer's stage or where it has recurred.

Ultimately, the goal is to improve how we plan treatments for prostate cancer patients. By getting a more accurate map of the cancer, doctors might be able to offer more targeted treatments, which could lead to better results for patients. The study will also carefully check for any potential side effects of the scans and look at the practical aspects of using this new technology in hospitals.

Key takeaways

Exploring new advanced scans (PET/MRI) for prostate cancer.
Aims to improve accuracy in finding and staging prostate cancer.
May lead to more personalised treatment plans.
Specifically for men with intermediate or high-risk prostate cancer.
Checks for safety and effectiveness of the new scanning method.

Who may be eligible?

To join this study, you must be a man aged 18 or older. There isn't an upper age limit, meaning men of any adult age can take part.

This study is specifically for men who have been diagnosed with prostate cancer that is considered 'intermediate' or 'high-risk.' This means your doctor believes your cancer has a higher chance of growing or spreading, or it has already shown signs of being more aggressive.

Before you can join, the study team will review your medical information to make sure the study is a good fit for you. They will explain everything in more detail.

Quick self-check

Are you a man?
Are you 18 years old or older?
Have you been diagnosed with intermediate or high-risk prostate cancer?
Are you able to attend appointments for specialized scans?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will undergo special scans called 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI. These scans involve receiving a small amount of a special substance (the 'tracer') that helps highlight cancer on the images. You will have a few visits to the hospital for these imaging tests.

During your participation, doctors will closely monitor your PSA levels, which is a blood test often used to check for prostate health. The study team will track any side effects you might experience from the scans and follow up on your treatment plan after the scans. The total duration of your participation will depend on how your treatment is planned and whether you are part of the group looking at cancer returning. They will explain the exact number of visits and their timing during the consent process.

Potential risks and benefits

Participating in this study might offer you the benefit of receiving highly advanced scans that could give your doctors a more detailed understanding of your prostate cancer. This could lead to a more tailored and potentially more effective treatment plan. However, there are potential risks, such as exposure to a small amount of radiation from the scans and possible side effects from the tracer, though these are usually mild and rare. You should be aware that the information gained from these new scans might or might not change your current treatment plan. Your participation is completely voluntary, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

—
Poland

Common questions

What is prostate cancer?

Prostate cancer is a common cancer that affects the prostate gland, a small gland in men that sits just below the bladder.

What is a PET/MRI scan?

A PET/MRI scan combines two types of detailed imaging: PET (Positron Emission Tomography) and MRI (Magnetic Resonance Imaging). It gives doctors very clear pictures of your body and helps find cancer cells.

What is the 68Ga-PSMA-11 tracer?

This is a special, safe substance that is given before the scan. It helps make cancer cells show up more clearly on the PET/MRI scan, allowing doctors to see them better.

Will this scan directly treat my cancer?

No, the scan itself doesn't treat the cancer. It's a diagnostic tool that provides more information to help your doctors plan the best possible treatment for you.

Is this scan available to everyone?

Currently, this advanced scan is part of a research study to assess its benefits. If it proves to be very helpful, it might become more widely available in the future.