NCT06651632

WATER IV Prostate Cancer

WATER IV Prostate Cancer: Aquablation Versus Radical Prostatectomy for the Treatment of Localized Prostate Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: PROCEPT BioRobotics · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, prospective, randomized clinical trial that aims to assess the safety and efficacy of Aquablation Therapy in men with low-risk to intermediate to high-risk localized prostate cancer who are candidates for, or have opted for, prostatectomy. Participants will be randomized to either Aquablation Therapy or radical prostatectomy and followed up to 10 years.

Conditions

• Localized Prostate Cancer

Interventions

Type	Name	Description
DEVICE	Aquablation Therapy	The AquaBeam Robotic System and the HYDROS Robotic System utilize high-velocity sterile saline waterjet to resect prostate tissue, guided by real-time visualization through cystoscopy and transrectal ultrasound imaging. This minimally invasive surgical procedure is called the Aquablation therapy.
PROCEDURE	Radical Prostatectomy	Radical prostatectomy is a surgery that is performed through an incision in the lower abdomen or perineum, or with a laparoscope or robotic system to remove the entire prostate gland.

Timeline

• Start date: 2025-02-03
• Primary completion: 2027-07-01
• Completion: 2037-01-01
• First posted: 2024-10-22
• Last updated: 2026-03-31

Locations

37 sites across 7 countries: United States, Canada, Germany, Hong Kong, Portugal, Taiwan, United Kingdom

Regulatory

• FDA-regulated device study