RecruitingNAINTERVENTIONAL

A Study to Evaluate the Performance of Confocal Microscopy to Detect Positive Margins During Radical Prostatectomy

This research is looking at a new technique called "LaserSAFE" to see if it can accurately find cancer cells at the very edge of the prostate gland during surgery. Finding these cells, known as a "positive margin," is important because it tells surgeons if more tissue needs to be removed. The LaserSAFE method uses a special microscope in the operating room to quickly check the removed prostate. This information could help surgeons make better decisions about whether to save the nerves around the prostate, potentially reducing side effects like problems with urinating or erections. This is particularly important for patients who might not usually be considered suitable for nerve-sparing surgery. The study also aims to check how quickly and reliably LaserSAFE works during the operation.

At a glance

Status

Recruiting

Phase

Sponsor

University College, London

Enrolment target

693

Start

20 Apr 2026

Estimated completion

20 May 2031

Prostate Cancer Prostate Cancer (Adenocarcinoma)

What is this study about?

When men have surgery to remove their prostate because of cancer, it's very important to make sure all the cancer is gone. Sometimes, cancer cells can be found right at the very edge of the removed prostate tissue. This is called a "positive margin," and it means there's a chance some cancer cells might have been left behind. Finding out about positive margins during surgery could help doctors make the best decisions at that moment.

This study is testing a new tool called "LaserSAFE." It's like a special, powerful microscope that can quickly look at the prostate tissue right after it’s been removed during surgery, while the patient is still in the operating room. The main aim is to see if LaserSAFE can accurately spot these cancer cells at the edges of the prostate. If it can, this could be a big help for surgeons.

One of the most important things LaserSAFE might help with is deciding whether to save the nerves around the prostate. These nerves are very important for things like bladder control and sexual function. Surgeons always try to save them if it's safe for the patient, but they also need to make sure all the cancer is removed. If LaserSAFE can quickly confirm that the edges are clear of cancer, it might give surgeons more confidence to save these nerves, even for patients who might not usually be offered nerve-sparing surgery. This could mean a better quality of life after surgery for many men.

Key takeaways

This study is testing a new microscope technology, LaserSAFE, during prostatectomy.
LaserSAFE aims to quickly find any cancer cells at the edge of the removed prostate.
The goal is to help surgeons decide if it's safe to save important nerves around the prostate.
This could potentially improve bladder control and sexual function after surgery.
Participation involves quality of life questionnaires and the use of LaserSAFE during your planned surgery.

Who may be eligible?

To join this study, you would need to be a man diagnosed with prostate cancer that is significant enough to require surgery, but has not yet spread to other parts of the body. You also need to be well enough to undergo a robotic prostate removal operation. Importantly, doctors would have already recommended against saving all the nerves around your prostate, or saving them on at least one side, based on your scans and biopsy results.

There are also reasons why you might not be able to join. For example, if you've already had certain treatments for prostate cancer like hormone therapy, radiotherapy, or chemotherapy, you wouldn't be eligible. Also, if your scans show a very low or very high chance of the cancer growing outside the prostate in certain areas, or if there's cancer directly involving nearby organs like the rectum or seminal vesicles, you wouldn't be able to participate.

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 who has been diagnosed with prostate cancer needing surgery?
Are you generally fit enough for robotic prostate surgery?
Has your doctor already suggested it might not be possible to save all the nerves around your prostate?
Have you NOT had previous treatments for prostate cancer like radiotherapy or hormone therapy?
Can you understand information in English and give informed consent?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your journey would look something like this:

Before your surgery, you would fill out a questionnaire about your quality of life. This helps researchers understand how you're feeling before the operation.

During your standard robotic prostate surgery, the surgeon will initially try to save the nerves around your prostate where possible. Crucially, the removed prostate gland will then be examined using the new LaserSAFE technique right there in the operating room. If LaserSAFE finds any cancer cells at the edges, surgeons will remove a small additional piece of tissue to ensure all cancer is gone.

After your surgery, you will attend routine follow-up appointments as you normally would for prostate cancer care. You'll also be asked to complete quality of life questionnaires again at 3 months and 12 months after your operation. There are no extra hospital visits beyond your normal care, and you won't need to take any new medications just for this study.

Potential risks and benefits

Potential benefits of taking part could include helping to advance medical understanding, which might improve how prostate cancer surgeries are performed in the future. For you personally, if LaserSAFE helps the surgeon confirm clear margins, it might increase the chances of successfully preserving nerves, which could lead to better quality of life outcomes. However, there's no guarantee of direct personal benefit. As with any surgery, there are general risks associated with prostatectomy, which your surgeon will discuss with you. Taking part in this study does not add significant new risks beyond those of the planned surgery. You are free to withdraw from the study at any time without giving a reason, and this would not affect the quality of your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University College London Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'positive margin' in prostate cancer surgery?

A positive margin means that cancer cells are found right at the edge of the prostate tissue that was removed during surgery. It suggests some cancer might have been left behind.

What are 'nerves around the prostate' and why are they important?

These nerves help control your bladder and sexual function. Surgeons try to save them if it's safe to do so, to help maintain your quality of life after surgery.

Is LaserSAFE safe?

LaserSAFE is a technique used on the prostate tissue after it's been removed from your body, so it doesn't directly interact with you during surgery or pose additional risk.

Will I get extra checks or medication in this study?

No, you will not receive any extra medication. You'll have extra quality of life questionnaires, but no additional hospital visits beyond your usual care.

Can I choose not to be in the study if I decide later?

Yes, you can choose to leave the study at any time, and it won't affect your medical care.

How to find out more

Ricardo Almeida-Magana, Dr

r.magana@ucl.ac.uk +44 02076792000 Official trial record

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