PROCEPT BioRobotics Completes WATER IV Prostate Cancer Study Enrollment, Receives FDA Approval for Second Trial
核心洞察
PROCEPT BioRobotics completed enrollment of 280 patients in the WATER IV RP study, the first FDA randomized trial comparing Aquablation therapy to radical prostatectomy for prostate cancer treatment.
The FDA granted investigational device exemption approval for a second randomized WATER IV AS study that will evaluate Aquablation therapy versus active surveillance in up to 333 patients with Grade Group 1 and 2 prostate cancer.
Both studies will follow patients for ten years to assess disease control and quality-of-life outcomes, with primary endpoint results from the first study expected at the 2027 American Urological Association Annual Meeting.
PROCEPT BioRobotics has achieved two significant milestones in its prostate cancer clinical program, completing enrollment in its first randomized study and receiving FDA approval for a second trial evaluating Aquablation therapy as an alternative treatment approach for men with localized prostate cancer.
WATER IV RP Study Reaches Full Enrollment
The company announced completion of enrollment in the WATER IV RP study, which randomized 280 patients to receive either Aquablation therapy or radical prostatectomy. This represents the only FDA randomized study comparing Aquablation therapy to radical prostatectomy, the established surgical standard of care for prostate cancer treatment.
The study enrolled patients aged 45 years and older with biopsy-positive Grade Group 1 to 3 prostate cancer who were candidates for radical prostatectomy. Eligible patients had clinical stage T2c disease or lower, prostate-specific antigen levels of 20 ng/mL or less, and prostate volumes of at least 25 mL.
Based on current timelines, PROCEPT BioRobotics expects to present the WATER IV RP primary endpoint results at the American Urological Association Annual Meeting in spring 2027. The study's co-primary endpoints focus on rate of pad use for urinary incontinence and rate of erectile dysfunction, while secondary endpoints include disease control and quality-of-life outcomes affecting urinary, sexual, and overall function.
FDA Approves Second Randomized Protocol
The FDA granted investigational device exemption approval for the WATER IV AS study, which will enroll up to 333 patients globally to evaluate Aquablation therapy versus active surveillance in men with Grade Group 1 and 2 prostate cancer.
This second protocol addresses a critical clinical question for men with lower-risk prostate cancer. Active surveillance is commonly used for these patients to avoid the quality-of-life impact associated with radical treatment, although many patients ultimately progress to surgery or radiation over time. The WATER IV AS study is designed to evaluate whether Aquablation therapy may provide an earlier treatment option for men on active surveillance before disease progression occurs.
Patients in the WATER IV AS study will be followed for ten years, including biopsy assessment at one year and MRI-based whole gland evaluation at three years.
Aquablation Technology and Clinical Approach
Aquablation therapy utilizes ultrasound-guided, transurethral robotic waterjet technology using a saline solution to resect prostate tissue. The procedure is designed to remove cancer, at-risk tissue, and any obstructive tissue, resulting in more than 95% of the gland being resected while leaving only the outer prostatic capsule intact.
"We are excited to complete enrollment in the first randomized WATER IV protocol, reflecting strong interest from physician investigators as well as patients in evaluating Aquablation as a new approach to prostate cancer treatment," said Larry Wood, President and Chief Executive Officer of PROCEPT BioRobotics. "The IDE approval for the additional randomized 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."
Long-term Follow-up and Clinical Significance
Both randomized WATER IV protocols will follow patients for ten years and are designed to evaluate the long-term experience of men with prostate cancer. The studies will assess both disease control and quality-of-life outcomes over time, including the impact of treatment on urinary, sexual, and overall function.
According to the company, no other prostate cancer therapy has been evaluated with such a level of rigor early in its development, reflecting PROCEPT BioRobotics' commitment to advancing science and innovation in prostate care. The comprehensive approach includes assessment of functional outcomes that are critical to patient quality of life following prostate cancer treatment.