FDA approves study of Aquablation vs radical prostatectomy in prostate cancer

The FDA has approved an investigational device exemption (IDE) trial that will compare Aquablation therapy with radical prostatectomy in the treatment of patients with localized prostate cancer, PROCEPT BioRobotics announced in a news release.¹

The primary end point for the trial is morbidity.

The acceptance of the IDE trial follows a previous FDA decision to grant a Breakthrough Device Designation to Aquablation for use in patients with prostate cancer. According to PROCEPT, “Breakthrough Device Designation is awarded in exceptional cases, expediting the review of novel therapies that can improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions.”¹

Aquablation therapy is currently approved in the United States for use in the treatment of patients with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) based on an FDA clearance granted in 2017.²

“A significant opportunity exists to improve safety and quality of life outcomes for men needing treatment for prostate cancer,” said Reza Zadno, CEO of PROCEPT BioRobotics, in the news release.¹ “We believe Aquablation therapy has the ability to become a first line treatment for localized prostate cancer. Initiating a randomized trial against radical prostatectomy is the first big step in pursuing a prostate cancer specific indication–which no other energy-based treatment has today.”

In total, the global, multicenter, prospective, randomized WATER IV PCa trial plans to enroll up to 280 patients with grade group 1 to 3 localized prostate cancer across 50 trial sites. The objective of the trial is to compare the safety and efficacy of first-line Aquablation vs radical prostatectomy in the management of localized prostate cancer.

Specifically, the primary end point for the trial is morbidity, which will be assessed at 6-month follow-up. Patients enrolled in the trial will be followed for up to 10 years, with longer-term assessment focused on the reduction in treatment-related harm and oncologic events.

“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 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 news release.¹ “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.”

Additional info on Aquablation

Aquablation was also granted an IDE approval from the FDA in September 2023 to initiate the launch of a single-arm feasibility study (NCT06054867) of the therapy in patients with localized prostate cancer.³

The study will include approximately 22 adult patients across 3 clinical trial sites: Keck Medical Center of USC, Perlmutter Cancer Center at NYU Langone Health, and Mount Sinai Tisch Cancer Center. To be eligible for enrollment in the study, patients need to have grade group 1 or 2 localized prostate cancer with a prostate-specific antigen level of 20 ng/ml or lower.⁴

The primary end point for the study is the proportion of patients who experience a serious device-related adverse event within 12 months following the Aquablation procedure.

Final completion of the study is anticipated for 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 8, 2024. https://ir.procept-biorobotics.com/news-releases/news-release-details/procept-biorobotics-received-us-fda-approval-initiate-pivotal

2. Reimbursement for Aquablation Therapy. PROCEPT BioRobotics. Accessed October 8, 2024. https://www.procept-biorobotics.com/healthcare-providers-us/reimbursement-for-aquablation-therapy

3. PROCEPT BioRobotics receives U.S. FDA investigational device exemption to investigate Aquablation therapy for prostate cancer. News release. September 12, 2023. Accessed October 8, 2024. https://ir.procept-biorobotics.com/news-releases/news-release-details/procept-bioroboticsr-receives-us-fda-investigational-device

4. PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System. ClinicalTrials.gov. Last updated August 14, 2024. Accessed October 8, 2024. https://clinicaltrials.gov/study/NCT06054867