RecruitingNAINTERVENTIONAL

Micro-ultrasound-Guided Focal Laser Ablation for Intermediate-Risk Prostate Cancer: Safety & Effectiveness

This research is investigating a treatment called Micro-Ultrasound Guided Focal Laser Ablation (MicroUSgFLA) for men with a specific type of prostate cancer (intermediate-risk). The main goal is to find out if this treatment is safe and if it can successfully slow down or even remove the need for more extensive treatments like surgery or radiation therapy. This laser treatment targets only the cancerous part of the prostate, which could be a gentler option than current full-gland treatments. The study also aims to show that MicroUSgFLA can be performed in more local clinics, rather than just large hospitals, making it easier for patients to access. This is because it uses micro-ultrasound to guide the treatment, which is simpler than MRI scans often needed for similar procedures.

At a glance

Status

Recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

Start

30 Apr 2025

Estimated completion

31 Dec 2027

Prostate Cancer (Adenocarcinoma)Low and Intermediate Risk Prostate Cancer

What is this study about?

Prostate cancer is very common in men, and many cases are considered 'low' or 'intermediate' risk. For these types, doctors are often looking for treatments that are less invasive and have fewer side effects than traditional surgery or radiation to the whole prostate gland. This study is exploring a new approach called Micro-Ultrasound Guided Focal Laser Ablation, often shortened to MicroUSgFLA.

Imagine targeting only the tiny area in the prostate where the cancer is, rather than treating the whole organ. That's the idea behind focal therapy. In this study, a special laser is used to precisely destroy the cancerous cells. What's new here is how they guide this laser: they're using a very detailed ultrasound (called 'micro-ultrasound'). This makes the procedure more straightforward than other focal therapies that often need complex MRI scans to guide them. The main benefit hoped for from this study is that this laser treatment could delay or even remove the need for more major treatments like surgery to remove the whole prostate or radiation therapy, which can come with significant side effects.

The researchers are hoping to show that if this treatment is successful, it could be offered in more local community settings, not just in big hospitals. This is because micro-ultrasound is easier to use and more widely available than MRI. It also means men who can’t have MRI scans (for example, due to metal implants or severe claustrophobia) might still be able to have this type of advanced, targeted treatment. The study will last for six months, looking closely at how safe and effective this treatment is.

Key takeaways

New laser treatment for intermediate-risk prostate cancer.
Aims to be less invasive than traditional treatments.
Uses micro-ultrasound guidance for precision.
Could make treatment more widely available in local clinics.
May delay or avoid the need for major surgery or radiation.

Who may be eligible?

This study is looking for men aged between 40 and 80 who have been diagnosed with a specific type of prostate cancer called 'intermediate-risk prostate cancer'. This usually means the cancer is contained within the prostate, is not too aggressive, and is of a certain size (no bigger than 15mm).

You would generally be considered for the study if your doctors have confirmed your cancer diagnosis with a biopsy and MRI or micro-ultrasound scans show the cancer is suitable for this type of targeted treatment. Your PSA level should be below 15 ng/mL, and you should be expected to live for at least another 10 years based on your overall health, excluding the prostate cancer itself. You'll also need to be able to fill out some questionnaires about your health before the procedure.

However, you wouldn't be able to join if your tumour is larger than 15mm, or if you're not well enough for this procedure. You also can't have had previous treatments for prostate cancer like surgery, radiation, chemotherapy, or certain hormone therapies. If you have other health conditions that might make the study unsafe for you, or if you can't have an MRI scan, you would also be excluded.

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 aged between 40 and 80?
Have you been diagnosed with intermediate-risk prostate cancer?
Is your cancer no more than 15mm in size?
Have you NOT had previous prostate cancer treatments like surgery or radiation?
Are you generally well and expected to live more than 10 years (unrelated to prostate cancer)?
Is your PSA level below 15 ng/mL?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the Micro-Ultrasound Guided Focal Laser Ablation treatment. This is a single-arm study, meaning everyone in the study will get the treatment being tested. The study will monitor your progress for six months after the treatment to assess its safety and effectiveness. This will involve appointments, possibly scans, and filling out health questionnaires. You will likely have initial assessments before the procedure and follow-up assessments at specific intervals over the six-month period to see how you are recovering and how the treatment has worked.

Potential risks and benefits

Participating in this study might offer you the benefit of receiving a less invasive, targeted treatment for your prostate cancer, potentially avoiding or delaying more extensive surgeries or radiation with their associated side effects. As with any medical procedure, there are potential risks, which will be fully explained to you by the study team before you decide to take part. These risks could include side effects from the procedure itself. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University Health Network - Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada· Recruiting

Common questions

What kind of prostate cancer is this study for?

This study is for men with 'intermediate-risk prostate cancer', which means the cancer isn't too aggressive and is contained within the prostate.

What is focal laser ablation?

It's a way to treat prostate cancer by using a special laser to destroy only the cancerous part of the prostate, leaving the healthy parts untouched.

Why is micro-ultrasound important for this treatment?

Micro-ultrasound helps doctors precisely guide the laser to the cancer, making the treatment more accurate and potentially allowing it to be done in more local clinics rather than only large hospitals.

Can this treatment replace major surgery?

The study aims to see if this treatment can postpone or even remove the need for more extensive treatments like full prostate removal surgery or radiation therapy.

How long will the study last if I participate?

The study will track your progress for six months after you receive the laser treatment.

How to find out more

Kateri Corr

kateri.corr@uhn.ca 416-946-4501 Official trial record

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