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AuthorisedPhase I and Phase II (Integrated)- First administration to humansInterventional

99mTechnetium and Cyanine-5 (HybriD) Prostate Specific Membrane Antigen (PSMA) Tracer-gUided Surgery in ProstAte Cancer - a FeasibiLity Study (DUAL study)

This study, called DUAL, is testing a new method to help surgeons find and remove prostate cancer more accurately during an operation. They are using a special substance, called a 'hybrid PSMA tracer', which combines a mild radioactive material with a fluorescent dye. This tracer is designed to attach to prostate cancer cells, making them glow under certain lights. This helps surgeons see the cancer better, even very small parts that might be hard to spot with the naked eye. The main goal is to see how well this tracer helps identify cancerous areas. The study is also looking at how safe the tracer is, how it spreads in the body, and how accurately it helps surgeons find cancer during surgery. This research could lead to more effective prostate cancer removal.

At a glance

Status
Authorised
Phase
Phase I and Phase II (Integrated)- First administration to humans
Sponsor
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Enrolment target
13
Start
11 Jul 2025

What is this study about?

This research study, known as the DUAL study, is investigating a new technique to improve how prostate cancer is treated with surgery. When doctors perform surgery for prostate cancer, it's very important to remove all the cancerous cells. Sometimes, small areas of cancer can be hard to see.

This study uses a special 'tracer' – a substance that is injected into the body. This particular tracer, called a 'hybrid PSMA tracer', has two parts: a very low dose of radioactive material (99mTechnetium) and a special fluorescent dye (Cyanine-5). Prostate cancer cells tend to absorb this tracer. The radioactive part allows doctors to see the cancer through scans, and the fluorescent dye makes the cancer cells glow under a special light during surgery. This can help surgeons find the cancer more precisely, including any small parts that might otherwise be missed.

Essentially, the study wants to see how well this special tracer works in finding prostate cancer within the body and during an operation. Researchers will be checking if the tracer successfully highlights cancer cells and how easily surgeons can use it to guide their work. They will also be carefully monitoring the safety of the tracer and how it moves within the body. The hope is that this new approach could lead to more accurate surgeries and better results for men with prostate cancer.

Key takeaways

  • Tests a new method to help surgeons find prostate cancer during surgery.
  • Uses a special 'tracer' that makes cancer cells visible.
  • Aims for more accurate cancer removal with improved surgical guidance.
  • Carefully checks the safety and effectiveness of the tracer.
  • Could lead to better outcomes for men with prostate cancer.

Who may be eligible?

To be considered for this study, you must be an adult male, at least 18 years old. There's no upper age limit, meaning older men can also take part if they meet other health criteria.

This study is specifically looking for men who have been diagnosed with prostate cancer and are planning to have surgery. The medical team will check details of your specific prostate cancer diagnosis and your general health to make sure the study is a good fit for you.

It's important to discuss with your doctor if you think this study might be right for you. They will review all your medical information to confirm if you meet the specific requirements for participation.

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.

  1. Are you an adult male (aged 18 or over)?
  2. Have you been diagnosed with prostate cancer?
  3. Are you scheduled to have surgery for your prostate cancer?
  4. Are you in general good health, allowing you to participate in a study?
  5. Are you willing to have an injection of the special tracer before your surgery?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have the special hybrid PSMA tracer injected. This injection is given just once before your planned prostate cancer surgery. Researchers will then check how the tracer spreads in your body using special scans, at different times after the injection (for example, one hour and fifteen hours later).

During your prostate cancer surgery, the surgeons will use special tools to see where the tracer has highlighted the cancer. They will also be monitoring how well they can use this new method. After your surgery, doctors will examine the removed tissue closely to compare it with what the tracer showed. You will also have a follow-up visit approximately 3 to 6 months after your operation to check your PSA levels (a marker for prostate health). The total duration of your active participation, including the follow-up, would be several months.

Potential risks and benefits

Participating in this study might offer a potential benefit by helping your surgical team more precisely identify and remove prostate cancer during your operation, which could lead to a more complete removal of the disease. However, as with any medical procedure, there are potential risks associated with the tracer, which will be carefully monitored, including possible side effects for 14 days after the injection. You are free 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.
  • Unverified
    Netherlands

Common questions

What is a 'tracer'?

A tracer is a special substance, like a dye or a mild radioactive material, that doctors can inject into your body. It helps illuminate specific parts of your body or certain types of cells, making them easier to see on scans or during surgery.

Will I feel unwell after the tracer injection?

The study will carefully monitor any side effects for 14 days after the injection. Your medical team will explain any known potential feelings or reactions you might experience, and they will be there to help if you have concerns.

Is the radiation from the tracer safe?

The tracer uses a very small, safe amount of radioactive material. Your doctors will explain the details of the dosage and any precautions. The aim is to use the lowest amount possible while still being effective for imaging.

How long will I be involved in the study?

You'll be involved from just before your surgery, through the operation itself, and then have a follow-up visit about 3-6 months later to check your progress. The main tests and procedures are centred around your surgery.

Could this tracer replace my surgery?

No, this tracer is not a treatment itself. It's a tool designed to help surgeons improve the existing prostate cancer surgery by making it easier to find all the cancer cells during the operation.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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