WATER IV PCa (AS Sub-study)
ConditionLocalized Prostate Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age45+
SponsorPROCEPT BioRobotics
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Aquablation Therapy
- Active Surveillance
Treatment groups
333 Participants
are divided into 2 treatment groupsLocations
17Arizona
Arizona State Urological Institute85224, Chandler United States
California
University of Southern California90089, Los Angeles United States
Colorado
Boulder Medical Center80304, Boulder United States
Florida
University of Miami33146, Miami United States
Sponsors and collaborators
PROCEPT BioRobotics
Lead sponsor
Source ClinicalTrials.gov