Ativo, mas não recrutandoNAINTERVENCIONISTA

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.

Em resumo

Status

Ativo, mas não recrutando

Fase

Patrocinador

PROCEPT BioRobotics

Meta de inscrição

280

Iniciar

03 Feb 2025

Conclusão estimada

01 Jan 2037

Localized Prostate Cancer

Sobre o que é este estudo?

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.

Pontos principais

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.
A participação é voluntária, e você pode se retirar a qualquer momento.

Quem pode ser elegível?

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.

Este estudo pode ser adequado para você?

Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.

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?

Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

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.

Riscos e benefícios potenciais

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.

Localizações (37)

Arizona State Urological Institute
Código postal verificado
Chandler, Estados Unidos
East Valley Urology Center
Código postal verificado
Mesa, Estados Unidos
Universidade do Sul da Califórnia
Código postal verificado
Los Angeles, Estados Unidos
Boulder Medical Center
Código postal verificado
Boulder, United States
Advanced Research
Código postal verificado
Delray Beach, United States
Universidade de Miami
Código postal verificado
Miami, Estados Unidos
Florida Urology Partners
Código postal verificado
Tampa, Estados Unidos
Trophy Point Urology
Código postal verificado
Tampa, Estados Unidos
Georgia Urology
Código postal verificado
Atlanta, Estados Unidos
Mountain View Hospital
Código postal verificado
Idaho Falls, United States
University of Chicago
Código postal verificado
Chicago, Estados Unidos
Endeavor Health
Código postal verificado
Glenview, United States

Perguntas frequentes

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.

Posso sair do estudo se mudar de ideia?

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

Como saber mais

Registro oficial do julgamento

Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.

Discussão

Discussão da comunidade

Desenvolvido pelo nosso fórum em community.patient.info. Por favor, seja respeitoso — isto não é um conselho médico.