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A study to investigate using contrast-enhanced ultrasound during focal therapy for prostate cancer

This study is investigating a new way to use contrast-enhanced ultrasound during an operation called focal therapy for prostate cancer. Focal therapy aims to treat only the cancerous parts of the prostate, carefully avoiding healthy tissue. The special ultrasound helps surgeons better identify any cancer that might still be there after the main treatment. If more cancer is found, it can be treated straight away during the same operation. Researchers want to see how effective this method is, how it changes the operation, and if it's easy for doctors to learn. This could lead to better treatment outcomes for men with prostate cancer in the future.

At a glance

Status
Recruiting
Sponsor
Imperial College London
Enrolment target
118
Start
07 Nov 2025
Estimated completion
01 Jan 2027

What is this study about?

This study is looking into a new approach during an operation called focal therapy for prostate cancer. Focal therapy is a way of treating prostate cancer that focuses on destroying only the cancerous parts of the prostate, trying to leave as much healthy tissue as possible untouched. This can help reduce side effects compared to treatments that remove or treat the whole prostate.

During your focal therapy operation, if you join this study, your surgeon would use a special type of scan called contrast-enhanced ultrasound. This scan uses a safe substance that helps certain areas show up more clearly on the ultrasound. The idea is that this could help the surgeon see if any prostate cancer is still left after they have done the main part of the focal therapy. If they spot any remaining cancer, they can then treat it there and then, while you are still having the operation under anaesthetic.

The main goal of this study is to see how well this special ultrasound works. Researchers want to find out if it really helps surgeons, how it fits into the operation, and how long it takes for surgeons to learn to use it effectively. They also want to understand if it's a good idea to do bigger studies on this technique in the future, potentially making focal therapy even better for men with prostate cancer.

Key takeaways

  • Tests a new way to use ultrasound during prostate cancer focal therapy.
  • Aims to help surgeons find and treat any remaining cancer during the same operation.
  • Could help improve how well focal therapy works for prostate cancer.
  • Involves extra scans and follow-up tests like PSA, MRI, and biopsy.
  • Potential for better-targeted treatment with very small added risks.

Who may be eligible?

This study is looking for men who are aged 18 or over and have prostate cancer that is contained within the prostate (not spread outside). You would need to be planning to have focal therapy as your first treatment for your prostate cancer, using methods like HIFU, cryotherapy, or irreversible electroporation.

There are a few reasons why you might not be able to join. For example, if you've already had treatment for your prostate cancer like radiotherapy or surgery, or if you've had certain heart or lung conditions that make the special ultrasound agent unsafe for you. Also, if you can't have an MRI scan, you wouldn't be able to take part.

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 18 years old or older?
  2. Do you have prostate cancer that hasn't spread outside the prostate?
  3. Are you scheduled for focal therapy (HIFU, cryotherapy, or IRE) as your first prostate cancer treatment?
  4. Can you have an MRI scan and tolerate the special ultrasound liquid?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo your focal therapy operation as planned, under general anaesthetic. During the operation, your surgeon would use the special contrast-enhanced ultrasound to scan your prostate both before and after they deliver the treatment. If they see any areas that look like remaining cancer, they will treat those specific spots immediately, still under the same anaesthetic.

After your operation, you will have regular check-ups. This includes blood tests to check your PSA levels at 3 and 12 months after your surgery. You will also have an MRI scan of your prostate and a needle biopsy of your prostate at 12 months. These tests help the doctors find out if any cancer remains and how well the treatment worked. The study is expected to run from December 2023 to January 2028.

Potential risks and benefits

The main benefit of taking part is that using this special ultrasound might improve your prostate cancer treatment, potentially lowering the chance of you needing further treatment later on. However, there are small risks too; the operation might take a little longer, and there's a very small chance of extra risks from the additional treatment given during the operation. You are always free to change your mind and withdraw from the study at any time without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Imperial College Healthcare NHS Trust
    City only
    London, England

Common questions

What is focal therapy for prostate cancer?

Focal therapy treats only the cancerous parts of your prostate, aiming to destroy cancer cells while leaving healthy tissue unharmed and reducing side effects.

What is contrast-enhanced ultrasound?

It's a special scan that uses a safe liquid to help doctors see certain areas more clearly on the ultrasound, like potential cancer cells.

Will I be awake during the extra scanning?

No, if you join the study, the special ultrasound and any additional treatment would happen while you are under general anaesthetic for your focal therapy.

Are there any extra tests after the operation?

Yes, you'll have PSA blood tests at 3 and 12 months, and an MRI scan and biopsy of your prostate at 12 months after your treatment.

Who is paying for this study?

The study is funded by the National Institute for Health and Care Research (NIHR) in the UK.

How to find out more

Alexander Light

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

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