Active — Not RecruitingNot Applicable

WATER IV Prostate Cancer

United States280 participantsStarted 2025-02-03

Plain-language 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.

Who can participate

Age range45 Years

SexMALE

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Inclusion criteria

✓. Biological male with age ≥ 45 years at the time of consent
✓. Biopsy positive Grade Group 1-3 prostate cancer
✓. Are candidates for prostatectomy or, in the case of GG1 disease, have already selected a radical therapy as their treatment.
✓. Clinical Stage ≤ T2c
✓. PSA ≤ 20 ng/ml
✓. Prostate volume ≥25 ml

Exclusion criteria

✕. 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:

What they're measuring

Rate of pad use for urinary incontinence

Timeframe: 6 Months

Rate of erectile dysfunction

Timeframe: 6 Months

Trial details

NCT IDNCT06651632

SponsorPROCEPT BioRobotics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07

View on ClinicalTrials.gov More Localized Prostate Cancer trials