PROCEPT BioRobotics Completes 280-Patient WATER IV Study and Secures IDE for 333-Patient Trial
PRCT•PROCEPT BioRobotics completed enrollment of 280 patients in its randomized WATER IV RP study comparing Aquablation therapy to radical prostatectomy and received FDA IDE approval for a second 333-patient protocol versus active surveillance. Both trials will track ten-year disease control and quality-of-life outcomes, with primary results due spring 2027.
1. Enrollment Milestone
PROCEPT BioRobotics fully enrolled 280 patients in its first randomized WATER IV RP study, the only FDA trial comparing Aquablation therapy against the surgical standard of radical prostatectomy. The company plans to present primary endpoint results at the American Urological Association Annual Meeting in spring 2027.
2. IDE Approval Secured
The FDA granted Investigational Device Exemption approval for a second randomized protocol, WATER IV AS, which will enroll up to 333 men with Grade Group 1 and 2 prostate cancer to compare Aquablation therapy versus active surveillance. This IDE approval allows the company to evaluate earlier intervention options for patients avoiding immediate radical treatment.
3. Trial Design and Follow-Up
Both WATER IV RP and WATER IV AS protocols will follow participants for ten years, assessing disease control alongside urinary, sexual, and overall function outcomes. The studies include one-year biopsy assessments and three-year MRI whole-gland evaluations to measure long-term efficacy and quality of life.
4. Strategic Implications
These twin randomized trials represent the highest level of clinical rigor for a prostate cancer therapy in early development, potentially validating Aquablation as a less invasive alternative and expanding PROCEPT’s market opportunity in prostate cancer and lower urinary tract symptom treatments.
