FDA Oks Aquablation vs Prostatectomy Trial in Localized Prostate Cancer

• An investigational device exemption (IDE) trial that will compare Aquablation therapy with radical prostatectomy in localized prostate cancer has been approved by the FDA.
• The study, titled WATER IV PCa, plans to assess the safety and efficacy of the therapies in approximately 280 patients with localized prostate cancer.
• In addition, the trial is focusing on morbidity at 6 months.

The FDA has approved an IDE trial comparing Aquablation therapy with radical prostatectomy for the potential treatment of patients with localized prostate cancer.¹

In the WATER IV PCa trial, a global multicenter, prospective, randomized study, experts plan to evaluate the safety and efficacy of Aquablation therapy vs radical prostatectomy in approximately 280 male patients with Grade Group 1 to 3 localized prostate cancer.

The coprimary end point of the trial is based on morbidity evaluated at the 6-month follow-up. Longer-term follow-up will look at reduction in treatment-related harm as well as oncologic events. Patients enrolled in the study will be evaluated across 50 trial sites and followed for 10 years.

“WATER IV PCa, a unique and thoughtful trial design focusing on harm reduction by using Aquablation as first line treatment in comparison to radical prostatectomy, could potentially change the way urologists treat localized prostate cancer for millions of men,” said Inderbir Gill, MD, founding executive director of University of Southern California (USC) Urology, part of Keck Medicine of USC, and chairman of the Catherine & Joseph Aresty Department of Urology at Keck School of Medicine of USC, in the press release. “It is exciting to see that the FDA approved an IDE after a prompt and thorough review of the trial design, and we look forward to seeing the results of the forthcoming trial and are hopeful about the possibilities of this novel technology.”

Background on Aquablation Therapy

Previously, the FDA granted Aquablation therapy breakthrough device designation in the prostate cancer space. Currently, Aquablation is approved in the US for the treatment of patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia.²

In September 2023, the FDA also granted Aquablation an IDE approval, allowing for the start of a single-arm feasibility study (NCT06054867). Here, approximately 22 patients with localized prostate cancer are being treated with Aquablation across 3 clinical trial sites, including in California, Illinois, and New York.³

Enrollment in the study is open to patients aged 40 years and older who have Grade Group 1 or 2 localized prostate cancer with a prostate-specific antigen level of 20 ng/mL or lower.⁴ Patients must also have a prostate volume of 30 mL or greater.

Experts are assessing the proportion of patients who have a serious device-related adverse event within 12 months following the Aquablation procedure as the primary end point.

The estimated study completion date is in April 2025.

REFERENCES:

1. PROCEPT BioRobotics received U.S. FDA approval to initiate pivotal randomized clinical study for prostate cancer. News release. PROCEPT BioRobotics. October 7, 2024. Accessed October 10, 2024. https://tinyurl.com/yr69tra9

2. Reimbursement for Aquablation therapy. PROCEPT BioRobotics. Accessed October 10, 2024. https://tinyurl.com/234ppukz

3. PROCEPT BioRobotics receives U.S. FDA investigational device exemption to investigate Aquablation therapy for prostate cancer. News release. September 12, 2023. Accessed October 10, 2024. https://tinyurl.com/5aen5ues

4. PRCT002 prostate cancer treatment with the AQUABEAM robotic system. ClinicalTrials.gov. Updated August 14, 2024. Accessed October 10, 2024. https://clinicaltrials.gov/study/NCT06054867