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Procept BioRobotics Corp. last week announced that the U.S. Food and Drug Administration has approved an Investigational Device Exemption, or IDE, trial of its Aquablation therapy.

The San Jose, Calif.-based company also recently received Breakthrough Device Designation to investigate the use of Aquablation therapy for prostate cancer. The FDA awards such designations in exceptional cases, expediting the review of novel therapies that can improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions.

The technology could “change the way urologists treat localized prostate cancer for millions of men,” stated Dr. Inderbir Gill, founding executive director of USC Urology, part of the Keck School of Medicine at the University of Southern California.

Procept BioRobotics develops personalized treatment

Aquablation uses ultrasound-guided, robot-assisted, heat-free waterjet to resection and precisely eradicate prostate tissue. The system provides the surgeon with a multi-dimensional view of the patient’s prostate.

This approach therapy enables personalized treatment planning tailored to each patient’s unique anatomy, claimed Procept BioRobotics. It allows the surgeon to specify which areas of the prostate to remove while preserving the anatomy that controls erectile function, ejaculatory function, and continence.

Aquablation promises to be an effective cancer treatment while maintaining the patient’s quality of life, said Procept BioRobotics. (The company was featured on MassDevice‘s list of the top urology device stories so far in 2024.)

Procept BioRobotics initially received FDA IDE for its Aquablation procedure in September 2023. The company’s next-generation Hydros surgical robot — cleared by the FDA in August — delivers Aquablation therapy.

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Aquablation trial to follow patients for 10 years

The WATER IV PCa trial will compare Aquablation to radical prostatectomy. It will focus on harm reduction by using Aquablation as a first-line treatment in comparison with radical prostatectomy, said Procept BioRobotics.

The company added that it expects the study to enroll up to 280 men with Grade Group 1 to 3 localized prostate cancer. It will take place across 50 centers, following the patients for 10 years.

The trial has a co-primary endpoint based on morbidity evaluated at the six-month follow-up. Longer-term follow-up will focus on both the reduction in treatment-related harm and oncologic events, Procept said.

“A significant opportunity exists to improve safety and quality of life outcomes for men needing treatment for prostate cancer,” said Reza Zadno, CEO of Procept BioRobotics. “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,”

“It is exciting to see that the FDA approved an IDE after a prompt and thorough review of the trial design, and we look forward to seeing the results of the forthcoming trial and are hopeful about the possibilities of this novel technology,” said Gill. He is also chairman of the Catherine & Joseph Aresty Department of Urology at Keck. 

Editor’s note: This article was syndicated from The Robot Report sibling site MassDevice.