IDE enables a second randomized protocol evaluating Aquablation therapy versus active surveillance. Aquablation uses waterjet resection to precisely eradicate prostate tissue. It provides the potential for an effective cancer treatment while maintaining the patient’s quality of life.
In addition to the IDE, the company completed enrollment in its WATER IV study evaluating Aquablation versus radical prostatectomy.
The first randomized WATER IV study fully enrolled 280 patients. It’s the only FDA-randomized study comparing Aquablation to radical prostatectomy, the established surgical standard of care, the company said. The company expects to share primary endpoint results in 2027.
Procept said its second randomized study in the program (WATER IV AS) will enroll up to 333 patients globally. It evaluates Aquablation versus active surveillance in men with Grade Group 1 and 2 prostate cancer. The study aims to see whether Aquablation may provide an earlier treatment option for men on surveillance before the disease progresses further. Investigators plan to follow patients for 10 years, including biopsy at one year and MRI-based whole-gland evaluation at three years.
San Jose, California-based Procept initially designed Hydros to treat benign prostatic hyperplasia (BPH). The company says it represents the first AI-enabled robotic platform designed specifically for the treatment of BPH. Hydros received FDA clearance for treating BPH in August 2024. The company announced the system’s international launch earlier this year.
Procept President and CEO Larry Wood said:
“We are excited to complete enrollment in the first randomized WATER IV protocol, reflecting strong interest from physician investigators as well as patients in evaluating Aquablation as a new approach to prostate cancer treatment. The IDE approval for the additional randomized WATER IV protocol enables us to evaluate whether earlier intervention with Aquablation may offer men on active surveillance a quality-of-life-preserving treatment option rather than waiting for the disease to progress.”
