PROCEPT BioRobotics
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.
The WATER IV AS sub-study is a multicenter, prospective, randomized clinical trial that aims to evaluate the safety and efficacy of Aquablation therapy in men with low to intermediate risk localized prostate cancer who are candidates for active surveillance. Participants will be randomized to either Aquablation Therapy or active surveillance and followed up to 10 years.
Inclusion Criteria: 1. Biological male with age ≥ 45 years at the time of consent 2. Biopsy positive Grade Group 2 prostate cancer or biopsy positive Grade Group 1 MRI visible lesion (PI-RADS/Likert ≥ 3) 3. First prostate cancer diagnoses within 18 months (545 days) of consent 4. Are candidates for active surveillance 5. Clinical Stage ≤ T2c 6. PSA \< 15 ng/ml 7. Prostate volume ≥25 ml Exclusion Criteria: 1. 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 thera…
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.
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.