Active not recruitingNAINTERVENTIONAL

WATER IV Prostate Cancer

This research study, called WATER IV, is comparing two treatments for prostate cancer that is still contained within the prostate gland. The two treatments are Aquablation Therapy and radical prostatectomy (traditional surgical removal of the prostate). This study is for men whose prostate cancer is considered low-risk to higher-risk, and who are suitable for, or have chosen, prostate surgery as their treatment. Participants will be randomly assigned to receive one of these two treatments. Researchers will then closely monitor them for up to 10 years to see how safe each treatment is and how well it works. The aim is to understand which treatment might be better for men with this type of prostate cancer.

At a glance

Status

Active not recruiting

Phase

Sponsor

PROCEPT BioRobotics

Enrolment target

280

Start

03 Feb 2025

Estimated completion

01 Jan 2037

Localized Prostate Cancer

What is this study about?

You might have heard about different ways to treat prostate cancer when it's still inside the prostate gland and hasn't spread. This study, called WATER IV, is designed to compare two of these treatments: Aquablation Therapy and an operation called a radical prostatectomy. A radical prostatectomy is a common surgery where the whole prostate gland is removed. Aquablation Therapy is a newer technique that uses a high-pressure water jet to remove prostate tissue.

Researchers want to see if Aquablation Therapy is as safe and effective as radical prostatectomy for men with localized prostate cancer. This is important because understanding the pros and cons of different treatments helps doctors and patients make the best choices. By comparing these two methods, the study hopes to provide clearer information about their benefits and any potential downsides.

Participants in the study will be followed for a long time, up to 10 years. This long follow-up allows the researchers to get a really good understanding of how each treatment affects men over the years, including whether the cancer comes back, how their quality of life is, and any long-term side effects.

Key takeaways

Compares two treatments: Aquablation vs. traditional prostate surgery.
For men with prostate cancer that hasn't spread.
Participants will be randomly assigned to one treatment.
Involves long-term follow-up for up to 10 years.
Aims to understand treatment safety and effectiveness.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for men aged 45 or older who have been diagnosed with prostate cancer that is still contained within the prostate gland (meaning it hasn't spread). Your cancer should be classified as Grade Group 1, 2, or 3. You must also be a suitable candidate for prostate surgery, or have already decided that surgery is the right treatment for you.

There are certain reasons why you wouldn't be able to join. For instance, if you've had any previous treatment for your prostate cancer, such as surgery, radiation, hormone therapy, or chemotherapy, this study might not be suitable. Also, if you've had certain other medical conditions or treatments recently, like surgery for an enlarged prostate in the last 3 months, or if you can't stop taking blood-thinning medication, you might not be eligible.

Importantly, the study cannot include men if their cancer has spread to other parts of the body, like lymph nodes or bones. You also need to be able to understand what taking part means and commit to attending all the necessary check-ups for the full 10 years. If you have any ongoing medical issues that could make the surgery riskier or affect the study results, you would also not 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 aged 45 or older?
Do you have prostate cancer that hasn't spread to other parts of your body?
Have you been told you are suitable for prostate surgery?
Have you NOT had any previous treatment for your prostate cancer?
Are you able to attend appointments and commit to up to 10 years of follow-up?
Can you temporarily stop blood-thinning medicines if needed for surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first be assessed to make sure you meet all the requirements. Once confirmed, you'll be randomly assigned to receive one of two treatments: either Aquablation Therapy or a radical prostatectomy (which is traditional prostate surgery). This is like flipping a coin – you won't get to choose which treatment you receive as part of the study.

After your treatment, you'll have regular follow-up appointments with the study team. These check-ups will involve various tests and discussions with doctors to monitor your health and see how well the treatment is working. The researchers will be looking for any side effects and how your prostate cancer is responding. These follow-up visits will continue for a long time, up to 10 years, so it's a significant commitment.

Potential risks and benefits

Participating in any clinical trial has potential benefits and risks. A potential benefit could be access to a relatively new treatment like Aquablation Therapy, which might offer advantages over traditional surgery, although this is what the study aims to find out. Both Aquablation and radical prostatectomy are surgical procedures and carry common surgical risks such as bleeding, infection, and potential side effects like changes in urinary or sexual function. The study team will explain all known risks of both procedures in detail. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without explaining why, and this will not affect your future medical care.

Locations (37)

Arizona State Urological Institute
Verified postcode
Chandler, United States
East Valley Urology Center
Verified postcode
Mesa, United States
University of Southern California
Verified postcode
Los Angeles, United States
Boulder Medical Center
Verified postcode
Boulder, United States
Advanced Research
Verified postcode
Delray Beach, United States
University of Miami
Verified postcode
Miami, United States
Florida Urology Partners
Verified postcode
Tampa, United States
Trophy Point Urology
Verified postcode
Tampa, United States
Georgia Urology
Verified postcode
Atlanta, United States
Mountain View Hospital
Verified postcode
Idaho Falls, United States
University of Chicago
Verified postcode
Chicago, United States
Endeavor Health
Verified postcode
Glenview, United States

Common questions

What is 'localized prostate cancer'?

It means the cancer is only found inside the prostate gland and hasn't spread to other parts of your body.

What is Aquablation Therapy?

It's a newer way to treat the prostate using a high-pressure water jet to remove prostate tissue. This study is comparing it to traditional surgery.

What is 'randomized' mean in a study?

It means you'll be put into one of the treatment groups (Aquablation or traditional surgery) by chance, like drawing numbers from a hat. You won't get to choose which one.

How long will I be followed in this study?

The study involves a long-term follow-up, meaning you'll have check-ups and monitoring for up to 10 years after your treatment.

Can I leave the study if I change my mind?

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