The WATER IV PCa trial will compare Aquablation to radical prostatectomy. Procept expects the study to enroll up to 280 men with Grade Group 1 to 3 localized prostate cancer. It takes place across 50 centers, following the patients for 10 years. The study has a co-primary endpoint based on morbidity evaluated at the six-month follow-up. Longer-term follow-up focuses on both the reduction in treatment-related harm and oncologic events.
According to a news release, the trial focuses on harm reduction by using Aquablation as a first-line treatment compared to radical prostatectomy. Dr. Inderbir Gill, founding executive director of USC Urology, says it “could potentially change the way urologists treat localized prostate cancer for millions of men.”
San Jose, California-based Procept initially received FDA IDE for its Aquablation procedure in September 2023. Aquablation uses waterjet resection to precisely eradicate prostate tissue. It provides the potential for an effective cancer treatment while maintaining the patient’s quality of life. The company’s next-generation Hydros surgical robot — cleared by the FDA in August — delivers Aquablation therapy.
(Procept Biorobotics featured on MassDevice’s list of the top urology device stories so far in 2024.)
The image-guided, automated, heat-free robotic therapy uses real-time ultrasound imaging. This provides the surgeon with a multi-dimensional view of the prostate. Aquablation therapy enables personalized treatment planning tailored to each patient’s unique anatomy, Procept Biorobotics says.
“A significant opportunity exists to improve safety and quality of life outcomes for men needing treatment for prostate cancer. We believe Aquablation therapy has the ability to become a first-line treatment for localized prostate cancer. Initiating a randomized trial against radical prostatectomy is the first big step in pursuing a prostate cancer-specific indication– which no other energy-based treatment has today,” said Reza Zadno, CEO of Procept BioRobotics.
