A large and potentially definitive Phase 3 clinical trial to test a new, minimally invasive way of treating lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH) is now enrolling patients. The WATER study trial will compare the safety and efficacy of a procedure known as Aquablation with TURP, the current standard for treatment.
In LUTS, an abnormally enlarged prostate gland severely irritates or obstructs the uretha, making the proper and complete emptying of the bladder difficult so that urine is retained in the body. Both Aquablation and TURP — the transurethral resection of the prostate using an electric current — address this by removing the excess tissue causing the blockage. But TURP, while a successful surgical method, carries risks related to surgery as well as risks such as incontinence (urine leakage), retrograde ejaculation (ejaculation into the bladder) and, though infrequent, erectile dysfunction.
Created by Redwood Shores, California-based PROCEPT BioRobotics, the AquaBeam System that delivers Aquablation is designed to improve LUTS treatment by being both targeted and heat-free. The system combines image guidance and robotics to deliver Aquablation, a high-velocity waterjet therapy, to remove prostatic tissue, and aims to be the new treatment standard.
“Interventional therapy is an option to alleviate symptoms for men who fail medical management of benign prostatic hyperplasia, but current options are a trade-off between improvement of patient symptoms and a risk of complications. There is a need for a minimally invasive solution that offers a sustainable and significant improvement to quality of life and a reduced risk of adverse effects, including sexual side effects,” said Nikolai Aljuri, Ph.D., founder and CEO of PROCEPT BioRobotics.
“Our results represent a step in the right direction as they suggest the potential for Aquablation to revolutionize the prostate treatment paradigm. We look forward to the initiation of the WATER study, our global Phase 3 clinical study evaluating the safety and effectiveness of AquaBeam as compared to the current standard of care.”
A total of >200 men, ages 45 to 80, will be enrolled in the randomized and single-blinded WATER study at 10 sites across the U.S., part of a series of ongoing and international Phase 3 clinical trails comparing the safety and effectiveness of the two procedures to treat LUTS. Those primary endpoints will be evaluated at six months for safety and six months for efficacy after the procedure, with effectiveness measured using the International Prostate Symptom Score (IPSS) in both Aquablation and control groups. Participants will be followed for up to three years to allow for long-term analysis. The study expects to finish collecting endpoint data by December 2017, and be completed by September 2019.
The Aquabeam System was shown to have a 100 percent technical success rate, and IPSS scores that improved from 23.1 at baseline to 8.6 at six months in an earlier clinical trial in New Zealand, one of several Phase 1 and Phase 2 studies into its use. Mean prostate size at six months also reduced by 31 percent from baseline, according to study results. Adverse events were described as minimal and transient, and there were no reports of incontinence, or loss of erectile function. The mean procedural time was 48 minutes, with an Ablation treatment time of eight minutes; in a larger trial in Australia and New Zealand, it was reported to be 38 and five minutes, respectively. TURP, in contrast, usually takes between 60 and 90 minutes.
“Aquablation is a minimally invasive technique that results in efficient and precise resection of prostate tissue and may lessen the risks and discomfort associated with prostate surgical procedures,” said Dr. Peter Gilling, the trial’s principal co-investigator. “The technology developed by PROCEPT BioRobotics has the potential to standardize benign prostatic hyperplasia surgery, reduce the level of complexity required to deliver safe and effective therapy and ultimately improve the quality of life for men suffering from benign prostatic hyperplasia.”
Preclinical studies, including in a canine model, also showed that the Aquabeam system selectively and successfully ablated prostate tissue without injury to nearby structures like blood vessels, researchers reported.
Throughout the entire procedure, the extent and depth of the ablation is predetermined by endoscopic and transrectal ultrasonography guidance, essentially tailoring each procedure to the individual needs of a patient. Removed tissue is collected for further analysis.
“The early clinical experience with Aquablation has demonstrated much promise and has evolved into a treatment scalable to hospitals worldwide,” Aljuri said. “The initiation of the WATER study is an important step to achieve our goal of providing men suffering from BPH a minimally invasive solution that offers both a sustainable and significant improvement to quality of life and a reduced risk of sexual side effects.”
Other countries conducting Phase 3 investigations into Aquablation versus TURP as part of the WATER study are Germany, Switzerland, and the United Kingdom in Europe, and Australia and New Zealand. WATER stands for Waterjet Ablation Therapy for Endoscopic Resection of the prostate tissue.
PROCEPT BioRobotics is a medical device company focused on the development of minimally invasive technology to surgically treat prostate disease.
Anyone interested in more information on the WATER study, including enrollment information and the location of the 10 U.S. sites conducting the trial, can use this link or access the formal study on clinicaltrials.gov (NCT02505919).