Active not recruitingNAINTERVENTIONAL

A Comparison of TULSA Procedure vs. Radical Prostatectomy in Participants With Localized Prostate Cancer

This study is looking for men with early-stage prostate cancer to compare two different ways of treating it. One is the usual operation, called a radical prostatectomy, which removes the whole prostate. The other is a newer, less invasive method called the TULSA procedure, which uses heat to destroy cancer cells in the prostate while trying to protect nearby areas important for your well-being. The main goal is to find out if the TULSA procedure is just as good at controlling cancer as the standard surgery, but with fewer long-term side effects that can affect your quality of life, such as issues with bladder control or sexual function. Researchers will follow participants for up to 10 years to understand the long-term results.

At a glance

Status

Active not recruiting

Phase

Sponsor

Profound Medical Inc.

Enrolment target

201

Start

01 Nov 2021

Estimated completion

31 Aug 2036

Prostate Cancer Prostate Adenocarcinoma

What is this study about?

When men are diagnosed with prostate cancer that hasn't spread, there are different ways to treat it. One common treatment is a major operation called a radical prostatectomy. This involves a surgeon removing the entire prostate gland. While this surgery is very effective at getting rid of the cancer, it can sometimes lead to lasting problems. These might include difficulty controlling your bladder (incontinence) or issues with sexual function, such as getting erections. For many men, avoiding these side effects is a big concern.

This study is exploring a newer, gentler approach called the TULSA procedure. TULSA is a keyhole-like procedure where a special device is gently guided into your body through natural openings, avoiding the need for large cuts. Using very precise MRI scans as a guide, it uses focused ultrasound waves to create heat, specifically targeting and destroying the cancer cells in your prostate. A key part of TULSA is that it aims to treat the cancer while carefully protecting the healthy parts of your prostate and the surrounding nerves and tissues that are important for your bladder control and sexual function.

The main reasons for doing this study are twofold. Firstly, researchers want to see if the TULSA procedure can help men maintain or even improve their quality of life – especially when it comes to bladder, bowel, and sexual health – one year after treatment, compared to those who have the traditional surgery. Secondly, they will track how many men remain free from cancer problems, like the cancer coming back or needing more treatments, three years after having the TULSA procedure, and compare this to men who had the standard operation. Around 200 men will take part across different hospitals, and they will be followed for up to 10 years.

Key takeaways

It's for men with early, intermediate-risk prostate cancer.
Compares standard surgery (radical prostatectomy) with the TULSA procedure.
TULSA uses heat to kill cancer and aims to reduce side effects.
The study wants to see if TULSA is as effective but gentler.
Participants will be followed for up to 10 years.
You will be randomly assigned to one of the two treatments.

Who may be eligible?

This study is looking for around 200 male volunteers. You would need to be between 40 and 80 years old, and your doctors would expect you to live for at least another 10 years. You should have been diagnosed with prostate cancer that hasn't spread to other parts of your body, and your cancer should be considered 'intermediate risk', meaning it's not too aggressive but needs treatment.

There are also some specific medical requirements, for example, your PSA blood test result should be below a certain level, and your prostate scans and biopsies will be checked to make sure the cancer is suitable for this study. The cancer should also be in certain parts of the prostate.

You wouldn't be able to join if you can't have an MRI scan or general anaesthetic. Other reasons you might not be suitable include having certain prostate or bladder issues, having had some other medical implants, or if doctors think traditional surgery isn't an option for you. You must also be willing and able to understand and agree 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.

Are you male, aged between 40 and 80?
Do you have prostate cancer that hasn't spread and is considered 'intermediate risk'?
Are you generally healthy and expected to live for more than 10 years?
Have you had a recent prostate biopsy and PSA blood test?
Can you have an MRI scan and a general anaesthetic?
Do you have good bladder function without certain pre-existing conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either the standard radical prostatectomy surgery or the TULSA procedure. This is like flipping a coin – neither you nor your doctor can choose which treatment you get. You will have regular check-ups and tests, including scans and blood tests, at set times over the next 10 years to monitor your health and the success of the treatment. There will also be questionnaires to assess your quality of life, especially regarding bladder control and sexual function. The exact number of visits and tests will be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer you access to a new, less invasive treatment that could lead to fewer side effects affecting your bladder control and sexual function compared to traditional surgery. However, with any medical procedure, there are always potential risks, which the study team will explain fully. For example, the TULSA procedure is newer, so its long-term effectiveness compared to surgery is still being studied. There's also the chance you might experience side effects from either treatment. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time without it affecting your usual medical care.

Locations (22)

Arizona State Urological Institute
Verified postcode
Chandler, United States
East Valley Urological Center
Verified postcode
Mesa, United States
Investigate MD
Verified postcode
Scottsdale, United States
Atlantic Urology Medical Group
Verified postcode
Long Beach, United States
Urology Group of Southern California
Verified postcode
Los Angeles, United States
University of California, Los Angeles
Verified postcode
Los Angeles, United States
Comprehensive Urology Medical Group
Verified postcode
Los Angeles, United States
Alarcon Urology Center
Verified postcode
Montebello, United States
Pasadena Urological Medical Group
Verified postcode
Pasadena, United States
Stanford Cancer Center
Verified postcode
Stanford, United States
Yale Cancer Center
Verified postcode
New Haven, United States
Mayo Clinic Jacksonville
Verified postcode
Jacksonville, United States

Common questions

What is 'localized, intermediate risk prostate cancer'?

This means your prostate cancer is only in the prostate gland and hasn't spread, and it's considered to be at a moderate level of aggression, needing treatment.

What's the main difference between the two treatments?

Radical prostatectomy is a major surgery to remove the whole prostate. The TULSA procedure uses heat to destroy cancer cells inside the prostate in a less invasive way, aiming to protect normal tissues.

How will I know which treatment I'll get?

You'll be randomly assigned to one of the two treatments – like drawing lots or flipping a coin. You won't be able to choose which one you receive.

How long will I be followed up in this study?

Researchers will keep in touch and monitor your health and treatment results for up to 10 years after your treatment.

Is the TULSA procedure available outside of this study?

The TULSA procedure is still being evaluated in studies like this one to understand its effectiveness and safety compared to standard treatments.