Not yet recruitingNAINTERVENTIONAL

Microwave Intervention Under Local Anesthesia

This study is testing a new way to treat localised prostate cancer. It uses a special microwave treatment called Koelis TMA® to target cancer cells, but instead of putting you fully to sleep, doctors will use a local anaesthetic to numb the area. This means you would be awake during the procedure. The main goal is to see if this method is comfortable and practical for patients. Researchers will also look at how safe it is, how easy it is for doctors to perform, how satisfied patients are, and if much pain relief is needed. It's designed to see if this less intensive approach could be a good option for future treatments.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Koelis

Enrolment target

Start

15 Jun 2026

Estimated completion

15 Jun 2027

Localised Prostate Cancer

What is this study about?

This study is looking into a new way to treat men with prostate cancer that is contained in one area (localised). Currently, some prostate cancer treatments involve general anaesthesia, where you are completely asleep. This study wants to see if a special microwave treatment, called Targeted Microwave Ablation (TMA) using a device called Koelis TMA®, can be done using only a local anaesthetic. This means you would be awake, but the area being treated would be numbed, similar to having a dental procedure.

The main point of this study is to find out if it's possible and comfortable to do this microwave treatment with local anaesthetic. This could potentially make the procedure simpler and reduce some of the risks associated with general anaesthesia. If successful, it might offer a different option for men needing this type of prostate cancer treatment in the future. The study will also carefully check how safe the procedure is, how easy it is for the doctors to perform, and how patients feel about the experience.

It's important to know that this device is already approved for use, but typically with general anaesthesia. This study is specifically looking at whether local anaesthesia is a good option. They are not changing how the microwave device itself works, just the type of anaesthetic used.

Key takeaways

This study explores a less invasive anaesthetic option for prostate cancer treatment.
It uses local anaesthetic for a microwave treatment called Koelis TMA®.
The main goal is to check if this approach is comfortable and practical for you.
Safety, patient comfort, and ease of procedure for doctors are key observations.
Participation involves 4 contacts over approximately one month.
You can stop the procedure if you feel too uncomfortable.

Who may be eligible?

To join this study, you need to be a man over 18 years old who has localised prostate cancer and is planning to have the Koelis TMA® treatment. It's important that you could safely have either general anaesthetic, local anaesthetic, or sedation, as the doctors might need to switch if the local anaesthetic isn't enough.

You also need to be able to understand the study information and give your consent freely. This means you shouldn't have any serious mental health conditions that would stop you from understanding what you're agreeing to, and you must be part of a social security or health scheme.

There are also some reasons why you might not be able to join. For example, if you've had a serious illness like a heart attack or stroke in the last six months, or if you have uncontrollable bleeding problems. You also can't be in this study if you're already taking part in another medical study or if you're unable to give informed consent due to legal reasons.

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 male and over 18?
Do you have localised prostate cancer?
Are you scheduled for Koelis TMA® treatment?
Are you generally healthy enough for surgery and different types of anaesthetic?
Can you understand the study information and agree to take part?
Have you recently had serious heart or brain problems (within 6 months)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have four main contacts over about a month. First, there's an initial visit where doctors will confirm you're suitable for the study and collect some health information. Then, at the next visit, you'll have the microwave treatment using local anaesthetic.

About a week after the procedure, the study team will call you to check how you're feeling and if you've had any problems. Finally, about a month after your treatment, you'll have a follow-up appointment during a routine clinic visit. Throughout this time, the team will be checking your comfort, any pain you might have, and how generally well you are. If at any point during the procedure you feel too uncomfortable, it can be stopped, and they might switch to general anaesthetic or deeper sedation if needed.

Potential risks and benefits

This study aims to make prostate cancer treatment potentially less invasive by using local anaesthetic, which could mean a quicker recovery and fewer risks associated with general anaesthesia. However, there's a chance you might still feel some discomfort or pain during the procedure, and in that case, the anaesthetic might need to be changed to general anaesthesia. As with any medical procedure, there are always potential side effects, and the study will carefully monitor these. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Institut Jules Bordet
Verified postcode
Brussels, Belgium
Hôpital Cochin Port Royal
Verified postcode
Paris, France

Common questions

What is Koelis TMA®?

It's a special device that uses microwave energy to treat small areas of prostate cancer. It is already approved for use.

What is local anaesthesia?

It's medication that numbs a specific part of your body. You remain awake during the procedure, unlike with general anaesthesia where you are fully asleep.

Why is this study being done?

Doctors want to see if this microwave treatment can be done safely and comfortably with local anaesthesia instead of general anaesthesia, potentially making it easier for patients.

What happens if I feel pain during the procedure?

If you experience discomfort or pain, the procedure can be stopped, and the medical team might give you general anaesthesia or deeper sedation to continue.

How long will I be involved in the study?

You'll have four contacts over about a month: an initial visit, the treatment, a phone call a week later, and a final check-up after a month.

How to find out more

JOSSAN Claire

claire.jossan@koelis.com +33 (0)7 85 05 40 23 Official trial record

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