A Phase 3 trial that will compare two types of surgery for an enlarged prostate — Procept BioRobotics‘ Aquablation water-beam approach versus the traditional approach of transurethral resection of the prostate (TURP) — has met its enrollment target.
The global trial of 184 patients, named WATER (NCT02505919), will compare the two procedures in a double-blind manner, meaning that neither patients nor investigators will know which surgery a patient receives.
“Thanks to the focus and commitment of the high-performing centers across three continents, we were able to complete enrollment of this ambitious study without delay,” Claus Roehrborn, MD, chair of the Department of Urology at the University of Texas Southwestern Medical Center in Dallas, said in a press release.
“The robust design of the WATER Study will provide us with comprehensive data related to the safety and effectiveness of Aquablation and a solid comparison to TURP, the most common procedure performed worldwide for the treatment of lower urinary tract symptoms due to [benign prostatic hyperplasia] BPH,” added Roehrborn, the study’s co-principal investigator.
Doctors who perform TURPs insert a surgical instrument through the urethra to cut away excess prostate tissue.
The 184 patients in Phase 3 of the WATER trial will be assigned to one of the two treatments randomly. Researchers will evaluate the therapies’ impact on symptoms and also look at side effects.
The research team will analyze the safety of the treatments after three months. At six months, they will assess symptoms with an International Prostate Symptom Score (IPSS).
Researchers will follow the patients for three years to collect long-term data on outcomes.
Aquablation is robotic surgery that uses a water beam to reduce the size of the prostate. Ultasound imaging helps surgeons target the ablation, or tissue to remove. The targeting means surgeons can avoid structures that are crucial to urinary continence and ejaculation.
Procept believes its approach, which uses its AquaBeam System, is beneficial regardless of prostate size and shape.
“By combining image guidance and robotics, the AquaBeam System has the potential to standardize BPH surgery through improved decision-making and procedural predictability,” said Peter Gilling, MD, the other co-principal investigator. He is a surgery professor at the University of Auckland and Tauranga Hospital in New Zealand.
“It was a tremendous accomplishment to complete this rigorous clinical trial in one year, and I want to acknowledge each of the sites and their investment in clinical research,” said Nikolai Aljuri, PhD, Procept’s co-founder and CEO.
“The completion of the WATER Study is an important step in achieving our goal of bettering the lives of men suffering from BPH by developing a minimally invasive solution that offers both a sustained and significant improvement to quality of life and a reduced risk of sexual side effects,” he said.
The AquaBeam System is available in the United States only for investigational use. The European Union has approved its use, and other countries are expected to do so this year.