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NOT YET RECRUITING
NCT07650448
NA

WATER IV PCa (AS Sub-study)

Sponsor: PROCEPT BioRobotics

View on ClinicalTrials.gov

Summary

The WATER IV study is a multicenter, prospective, randomized clinical trial that aims to evaluate the safety and efficacy of Aquablation therapy in men with localized prostate cancer.

Official title: WATER IV Prostate Cancer: Aquablation Versus Active Surveillance for the Treatment of Localized Prostate Cancer

Key Details

Gender

MALE

Age Range

45 Years - Any

Study Type

INTERVENTIONAL

Enrollment

333

Start Date

2026-09

Completion Date

2038-12

Last Updated

2026-06-16

Healthy Volunteers

No

Interventions

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.

OTHER

Active Surveillance

Active surveillance is a management strategy for men with low- and favorable intermediate-risk localized prostate cancer that involves close monitoring with curative intent, reserving treatment for evidence of disease progression. Monitoring typically includes serial PSA testing, periodic prostate MRI, and repeat biopsies at scheduled intervals, with intervention triggered by evidence of disease progression.