Surgical Robotics Technology
PROCEPT BioRobotics® Corporation has announced the U.S. Food and Drug Administration (FDA) has approved a pivotal Investigational Device Exemption (IDE) clinical trial comparing Aquablation therapy to radical prostatectomy. The Company also recently received Breakthrough Device Designation to investigate the use of Aquablation therapy for prostate cancer. Breakthrough Device Designation is awarded 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 trial, known as WATER IV PCa, is a global multicenter, prospective, randomized clinical study assessing the safety and efficacy of Aquablation therapy compared to radical prostatectomy in men with Grade Group 1 to 3 localized prostate cancer. The study will enroll up to 280 patients at up to 50 centers and follow them for 10 years. There is 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.
“WATER IV PCa, a unique and thoughtful trial design focusing on harm reduction by using Aquablation as first line treatment in comparison to radical prostatectomy, could potentially change the way urologists treat localized prostate cancer for millions of men,” said, Inderbir Gill, MD, founding executive director of USC Urology, part of Keck Medicine of USC and chairman, Catherine & Joseph Aresty Department of Urology, Keck School of Medicine of USC. “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.”
“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, Chief Executive Officer of PROCEPT BioRobotics.
About Aquablation Therapy
Aquablation therapy is the first and only ultrasound guided, robotic-assisted, heat-free waterjet for the treatment of BPH. The system’s real-time ultrasound imaging provides the surgeon with a multi-dimensional view of the prostate enabling personalized treatment planning tailored to each patient’s unique anatomy. The surgeon can specify which areas of the prostate to remove while preserving the anatomy that controls erectile function, ejaculatory function and continence. Once the treatment plan is mapped by the surgeon, the predictable robotic-assisted execution enables prostate tissue to be removed in a precise, targeted, and controlled fashion.
Source: PROCEPT BioRobotics
