The FDA has given the green light to a pivotal Investigational Device Exemption (IDE) trial that will pit Aquablation therapy against radical prostatectomy in the treatment of localized prostate cancer. This decision marks a significant step forward for PROCEPT BioRobotics, the company behind Aquablation, and could potentially reshape how urologists approach early-stage prostate cancer treatment.
The trial, dubbed WATER IV PCa, is designed as a global, multicenter, prospective, randomized study. Researchers plan to enroll approximately 280 male patients diagnosed with Grade Group 1 to 3 localized prostate cancer. These patients will be recruited from 50 trial sites around the world and followed for a decade to assess long-term outcomes.
Trial Endpoints and Design
The primary endpoint of the WATER IV PCa trial will focus on morbidity, evaluated at the 6-month mark. Beyond this initial period, the study will track the reduction in treatment-related harm and the occurrence of oncologic events over the 10-year follow-up. This comprehensive approach aims to provide a thorough understanding of the therapy's safety and efficacy profile.
According to Inderbir Gill, MD, founding executive director of USC Urology, "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."
Aquablation Therapy: A Potential Paradigm Shift
Aquablation therapy has already received Breakthrough Device Designation from the FDA for its potential in prostate cancer treatment. Currently, it is approved in the U.S. for managing lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). The procedure utilizes a heat-free waterjet, guided by real-time ultrasound imaging, to precisely remove prostate tissue. This approach allows surgeons to personalize treatment plans, targeting specific areas while preserving the anatomy responsible for erectile function, ejaculatory function, and continence.
Reza Zadno, CEO of PROCEPT BioRobotics, stated, "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."
Prior FDA Approvals and Ongoing Studies
In September 2023, the FDA granted PROCEPT BioRobotics an IDE approval to conduct a single-arm feasibility study (NCT06054867) of Aquablation in localized prostate cancer. This study is enrolling approximately 22 patients across three clinical trial sites and is expected to be completed in April 2025. The primary endpoint is the proportion of patients experiencing a serious device-related adverse event within 12 months of the procedure.
