RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Aquablation Therapy for Localized Prostate Cancer

The WATER IV study is a multicenter, prospective, randomly assigned clinical trial that aims to measure the safety and how well it works of Aquablation therapy in men with localized prostate cancer.

Official registry: https://clinicaltrials.gov/study/NCT07650448 · PROCEPT BioRobotics · enrollment listed as 333

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Aquablation Therapy, or Active Surveillance. The registry lists allocation as randomized. The WATER IV study is a multicenter, prospective, randomly assigned clinical trial that aims to measure the safety and how well it works of Aquablation therapy in men with localized prostate cancer.

They plan to enroll about 333 people at 28 sites. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

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

Interventions: Aquablation Therapy, Active Surveillance

Primary outcome (registry wording): Freedom from GG ≥ 2

Who it is for (from inclusion criteria)

Ages 45 Years to any
Men only
Biological male with age ≥ 45 years at the time of consent
Biopsy positive Grade Group 2 prostate cancer or biopsy positive Grade Group 1 MRI visible lesion (PI-RADS/Likert ≥ 3)
First prostate cancer diagnoses within 18 months (545 days) of consent
Are candidates for active surveillance
Clinical Stage ≤ T2c
Prostate volume ≥25 ml

Who the registry excludes

Any prior or current local or systemic treatment for prostate cancer, including but not limited to surgery, radiation therapy (external or brachytherapy), tissue ablation, hormone therapy or chemotherapy
Patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 3 months of study treatment
Evidence of lymph node, bone metastasis, extracapsular extension or seminal vesicle invasion
Patient is unwilling to accept a blood transfusion if required
Any condition or history of illness or surgery that may pose an additional risk to patients undergoing the Aquablation or radical prostatectomy procedure such as:
7\. Patient currently participating in other studies unless approved by Sponsor in writing
8\. More than one complete biopsy beyond the diagnostic biopsy comprising both a systematic biopsy and biopsy of any MRI visible lesion (PI-RADS/Likert ≥ 3)

Public study contact (from the registry)

Angela Lee

650-232-7215

a.lee@procept-biorobotics.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

28 listed

Arizona State Urological Institute — Chandler, Arizona (not_yet_recruiting)
University of Southern California — Los Angeles, California (recruiting)
Tri Valley Urology — Murrieta, California (not_yet_recruiting)
Boulder Medical Center — Boulder, Colorado (not_yet_recruiting)
Advanced Research — Delray Beach, Florida (recruiting)
University of Miami — Miami, Florida (not_yet_recruiting)
Trophy Point Urology — Tampa, Florida (not_yet_recruiting)
Georgia Urology — Atlanta, Georgia (recruiting)
Mountain View Hospital — Idaho Falls, Idaho (recruiting)
University of Chicago — Chicago, Illinois (not_yet_recruiting)
Endeavor Health — Glenview, Illinois (recruiting)
Johns Hopkins University — Baltimore, Maryland (not_yet_recruiting)

+ 1 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07650448 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07650448?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07650448?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary