Aquablation procedures for prostate cancer completed at ambulatory surgery center

Three patients with prostate cancer have successfully underwent Aquablation procedures in an ambulatory surgery center (ASC), PROCEPT BioRobotics reported in a news release.¹

The procedures were completed by Rahul Mehan, MD, of East Valley Urology Center in Scottsdale, Arizona as part of the ongoing, pivotal WATER IV Prostate Cancer (PCa) Trial.

“While most WATER IV PCa trial sites will treat patients in a hospital setting, Dr. Mehan has elected to treat his randomized Aquablation therapy trial patients at an ASC,” said Barry Templin, chief technology officer of PROCEPT BioRobotics, in the news release from the company.¹ “This announcement marks a major milestone: we have demonstrated early-stage prostate cancer can be safely treated at an ASC with Aquablation therapy. With a prostate cancer treatment approach that removes significantly more tissue than a typical BPH procedure or focal therapy, Dr. Mehan successfully completed all procedures and discharged patients the same day without complications. This is indicative of not only a safe prostate resection, but also the potential for a more scalable, cost-effective care model in a rapidly changing market.”

About the WATER IV PCa Trial

The WATER IV PCa trial (NCT06651632) is an investigational device exemption (IDE) study comparing the safety and efficacy of first-line Aquablation therapy with that of radical prostatectomy in the treatment of patients with localized prostate cancer.²

In total, the global, multicenter, prospective WATER IV PCa trial plans to enroll up to 280 patients with grade group 1 to 3 localized prostate cancer. To be eligible for enrollment, patients need to be candidates for or have opted for radical prostatectomy. Participants also need to be aged 45 years or older and have clinical stage T2c disease or lower, a prostate-specific antigen level of 20 ng/mL or lower, and a prostate volume of at least 25 mL.

Patients in the study with be randomly assigned to Aquablation therapy with the AquaBeam or HYDROS robotic system or to radical prostatectomy.

The dual primary end points for the trial are the rate of pad use for urinary incontinence and the rate of erectile dysfunction at 6 months following the procedure. Patients enrolled in the trial will be followed for up to 10 years, with longer-term assessment focused on the reduction in treatment-related harm and oncologic events, according to PROCEPT.³

Primary completion of the trial is anticipated in July 2027.

“WATER IV PCa, a unique and thoughtful randomized trial design focusing on harm reduction by using Aquablation therapy as first-line treatment in comparison to radical prostatectomy for men with grade group 1 to 3 localized prostate cancer, could potentially change the way urologists treat localized prostate cancer for millions of men,” said global co-principal investigator Inderbir Gill, MD, of the University of Southern California, Los Angeles, in the news release.¹ “It is exciting to see that the FDA approved this IDE after a prompt and thorough review of the trial design, and we look forward to seeing the results of our forthcoming trial and are hopeful about the possibilities of this novel treatment approach for the most commonly diagnosed internal cancer in men.”

REFERENCES
1. Ambulatory Surgery Center completes WATER IV Trial procedures for prostate cancer with Aquablation Therapy. News release. PROCEPT BioRobotics. July 23, 2025. Accessed July 24, 2025. https://ir.procept-biorobotics.com/news-releases/news-release-details/ambulatory-surgery-center-completes-water-iv-trial-procedures

2. WATER IV Prostate Cancer (WATER IV PCa). ClinicalTrials.gov. Last updated April 3, 2025. Accessed July 24, 2025. https://clinicaltrials.gov/study/NCT06651632

3. PROCEPT BioRobotics received U.S. FDA approval to initiate pivotal randomized clinical study for prostate cancer. News release. PROCEPT BioRobotics. October 7, 2024. Accessed July 24, 2025. https://ir.procept-biorobotics.com/news-releases/news-release-details/procept-biorobotics-received-us-fda-approval-initiate-pivotal