Skip to Main Content

WATER IV PCa STUDY

Connect with our Study Team

ABOUT THE STUDY

WATER IV Prostate Cancer (PCa) is a clinical study comparing investigational Aquablation® therapy and radical prostatectomy for the treatment of localized prostate cancer.

The study will evaluate and compare the safety and efficacy of Aquablation therapy and radical prostatectomy for men with Grade Group (GG) 1 to 3 localized prostate cancer. Aquablation therapy is an image-guided, minimally invasive surgery that aims to resect (remove) diagnosed cancer and most of the prostate using a robotically-controlled waterjet. Radical prostatectomy is a traditional surgery that removes the entire prostate along with some surrounding tissue. A surgical robot is often used to perform the radical prostatectomy surgery.

The WATER IV PCa study will include men who are candidates for, or have already selected, surgery for their prostate cancer treatment.

WHAT IS PROSTATE CANCER?

Prostate cancer is one of the most common types of cancer affecting 1 in 8 men according to both the American Cancer Society and Prostate Cancer UK.1,2 Prostate cancer is the abnormal growth of prostate cells that may spread to other parts of the body if not treated.

WHO IS A CANDIDATE FOR THE WATER IV PCa STUDY?

Biological males with grade group 1-3 localized prostate cancer.

Grade Groups

Grade groups indicate how different cancer cells look compared to normal prostate cells. Doctors perform a prostate biopsy to remove a small piece of prostate tissue to look at under a microscope. Based on how the cancer cells look, doctors assign a grade group (GG) from 1 (GG 1) to 5 (GG 5). The aggressiveness of the cancer is related to the cells’ appearance with GG 1 being the least likely to grow and spread and GG 5 the most likely.

Sometimes a different grading system is used and a “Gleason score” from 6-10 is assigned rather than a grade group. This system is named after Dr. Gleason who came up with the scoring system.

A diagnosis of GG1-3 prostate cancer is one of the requirements to participate in the WATER IV PCa study.

Localized Prostate Cancer

As part of a prostate cancer diagnosis, doctors “stage” the cancer. Staging prostate cancer is figuring out how much of the prostate contains cancer and if it has spread to other parts of the body. A tumor (T) score from 1-4 is assigned. If the prostate cancer is stage T1 or T2, the cancer is localized which means it is only inside the prostate. Stage T3 and T4 indicate the cancer has spread beyond the prostate.

Having localized disease, that is T1 or T2, is another requirement to participate in the WATER IV PCa study.

See if you’re a potential candidate

This table outlines candidacy for the WATER IV PCa study based on Grade Group and Tumor Stage.
Connect with our Study Team
Table with cancer characteristic and if they are a potential candidate for Water IV PCa treatment

WHAT ARE THE TREATMENT OPTIONS IN THIS STUDY?

There are two treatment options for the WATER IV PCa study: Aquablation therapy and radical prostatectomy.

Aquablation therapy

An advanced, minimally invasive surgical treatment that uses image guidance, robotics, and a heat-free waterjet to remove prostate tissue.

  • The surgeon accesses the prostate through the urethra and uses ultrasound imaging to visualize the entire prostate.
  • For each patient, the treatment is planned by a surgeon based on their individual anatomy. Tissue for both resection and preservation is identified. Surgeons take care to avoid treatment too close to nearby sensitive structures including those responsible for sexual and urinary function.
  • The waterjet then follows the treatment plan and precisely resects the identified prostate tissue.
1
Illustration of treatment planning for prostate cancer

Treatment planning

2
Illustration of waterjet resecting prostate tissue

Waterjet Resecting Tissue

3
Illustration of a resected prostate

Resected Tissue

Radical prostatectomy

A surgical approach that accesses the prostate through one or several incisions in the abdomen.

  • Radical prostatectomies can be performed in one of three ways:
    • Open – single incision to access the prostate directly
    • Laparoscopic – multiple small incisions to access the prostate using laparoscopic instruments
    • Robotic – multiple abdominal incisions to access the prostate using instruments on a surgical robot.
  • The surgeon removes the prostate and surrounding anatomy such as the seminal vesicles and lymph nodes, if needed.

    • HOW ARE PARTICIPANTS ASSIGNED TO A PROCEDURE IN THE STUDY?

    The WATER IV PCa study is a randomized controlled trial. Participants who enter the study will be randomly assigned Aquablation therapy or radical prostatectomy. The randomization in the study is structured 3 to 1 for Aquablation therapy to radical prostatectomy.

    Illustration of WATER IV PCa clinical study arms

    WHAT CAN A PARTICIPANT EXPECT FROM THE STUDY?

    Illustration of treatment planning for with health care provide and patient

    WHAT CAN A PARTICIPANT EXPECT FROM THE STUDY?

    Assessment

    After a study-specific consent form is signed, the physician will review the potential study candidate’s medical history, including, but not limited to, MRI, PSA, and biopsy results to confirm eligibility.

    Randomization

    Qualified participants will be randomly assigned to Aquablation therapy or radical prostatectomy.

    Treatment

    Participants will arrive at their treatment appointment and follow all hospital instructions.

    Follow-Up

    Participants will return to meet their care team at regular intervals to conduct brief assessments and provide input on recovery.

    CAN I GET AQUABLATION THERAPY TO TREAT PROSTATE CANCER WITHOUT PARTICIPATING IN THIS STUDY?

    No. Although Aquablation therapy is commonly used to treat enlarged prostates due to benign prostatic hyperplasia (BPH), it is not available outside of this study as a prostate cancer treatment.

    PARTICIPATING HOSPITALS

    United States

    Los Angeles, California

    University of Southern California

    Atlanta, Georgia

    Georgia Urology

    Glenview, Illinois

    Endeavor Health

    Kansas City, Kansas

    University of Kansas Medical Center

    New York City, New York

    Icahn School of Medicine at Mount Sinai

    Austin, Texas

    Urology Austin

    Alexandria, Virginia

    Potomac Urology

    Canada

    Toronto, Ontario

    University of Toronto

    Montréal, Quebec

    Centre Hospitalier de l'Université de Montréal

    United Kingdom

    London, United Kingdom

    The Royal Marsden Hospital

    Colney, Norwich

    Norfolk & Norwich University Hospital

    Portugal

    Lisbon, Portugal

    Hospital Cruz Vermelha

    Hong Kong

    Shatin, Hong Kong

    Chinese University of Hong Kong

    Click here for contact information and details about these hospitals.

    CONNECT WITH OUR STUDY TEAM

    For more information, please email wateriv@procept-biorobotics.com

    The AquaBeam® Robotic System and HYDROS™ Robotic System are not indicated for the treatment of prostate cancer globally. Caution: Investigational device. Limited by Federal (or United States) law to investigational use only.

    References:

    1. https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html Accessed on 10/14/2024
    2. https://prostatecanceruk.org/ Accessed on 10/14/2024