Procept BioRobotics has received a second FDA investigational device exemption (IDE) to allow another randomised study of its Aquablation therapy.
The regulatory clearance permits the start of a study comparing Aquablation therapy to active surveillance in men with Grade Group 1 and 2 prostate cancer.
Aquablation therapy involves using a waterjet to remove prostate tissue.
Designed to compare Aquablation with radical prostatectomy, the standard surgical treatment for prostate cancer, the WATER IV study has reached full enrolment with 280 patients.
Procept BioRobotics anticipates sharing the primary endpoint results from WATER IV in 2027.
A second study under the IDE, called WATER IV AS, will enrol up to 333 patients worldwide.
This study aims to assess the potential of Aquablation as an earlier intervention for men currently on active surveillance, with a ten-year patient follow-up planned.
Key milestones include a biopsy at one year and magnetic resonance imaging (MRI)-based evaluation of the entire prostate at three years.
Both randomised WATER IV protocols are scheduled to monitor disease control, urinary and sexual function, and overall patient outcomes for a decade.
According to Procept BioRobotics, no other prostate cancer therapy has undergone a similar level of early-stage evaluation.
Procept BioRobotics president and CEO Larry Wood said: “We are excited to complete enrolment in the first randomised WATER IV protocol, reflecting strong interest from physician investigators, as well as patients in evaluating Aquablation as a new approach to prostate cancer treatment.
“The IDE approval for the additional randomised WATER IV protocol enables us to evaluate whether earlier intervention with Aquablation may offer men on active surveillance a quality-of-life-preserving treatment option rather than waiting for the disease to progress.”
The company reports that the studies represent an ongoing plan to collect long-term data on both disease control and post-treatment quality of life in men with prostate cancer.
In August 2024, the FDA issued 510(k) clearance for Procept BioRobotics’ Hydros Robotic System, which aims to deliver Aquablation therapy.
