Game-Changer? FDA Approves Aquablation Trial That Could Transform Prostate Cancer Care
The U.S. Food and Drug Administration (FDA) has approved a major study to compare Aquablation therapy with radical prostatectomy for men with localized prostate cancer.
This new trial, called WATER IV PCa, will involve about 280 men across 50 hospitals worldwide. It will test whether Aquablation, a robotic, water-based procedure, can be a safer and less damaging alternative to surgery for prostate cancer.
The main goal is to measure how much harm or side effects (morbidity) occur six months after treatment. Patients will then be followed for up to ten years to see long-term results.
Aquablation already has FDA approval for treating BPH (enlarged prostate) and holds Breakthrough Device Designation for prostate cancer, meaning the FDA sees it as a promising technology that could significantly improve care for men.
A smaller trial with 22 patients is also underway in the U.S. to confirm the safety of using Aquablation as a first-line treatment for prostate cancer.
Experts say this research could change how doctors treat prostate cancer, offering a way to reduce side effects and preserve quality of life for millions of men.
About the Author
Scott Oliver, 66, is living well with prostate cancer after dedicating more than 4,000 hours to researching the condition. His first goal is to help men reduce their risk of developing prostate cancer through proven lifestyle strategies.
When diagnosed, his mission is to help men avoid unnecessary prostate surgeries that can lead to devastating complications such as incontinence, bleeding, permanent impotence, and a loss of length.
Scott Oliver is not a doctor and does not offer medical advice; however, he is healthier and fitter than he has been in decades. Through his articles and videos, he shares hard-to-find, uncensored information on proven alternative therapies, effective fitness methods, and repurposed drugs, content that most doctors won’t mention and search engines suppress.
He is an accredited member of the National Writers Union (NWU) and the International Federation of Journalists (IFJ), the world’s largest organization of professional journalists. Scott is also the author of What If Cancer’s Best Defense Is Free? Sleep as a Defense Against Cancer: A Former Royal Marines Commando’s 4,000-Hour Research Roadmap, where he reveals how sleep repairs DNA, restores immunity, and strengthens the body’s natural defenses against cancer.
You can always contact Scott Oliver here with your questions and suggestions.
Scientific and Medical References Personally Reviewed by Scott Oliver.
- FDA Approves Study of Aquablation vs Radical Prostatectomy in Prostate Cancer
Overview of the newly approved WATER IV PCa trial comparing Aquablation therapy with radical prostatectomy for localized prostate cancer, highlighting its potential to change prostate cancer treatment. Read at Urology Times - PROCEPT BioRobotics Receives U.S. FDA Approval to Initiate Pivotal Randomized Clinical Study for Prostate Cancer
Official company press release announcing FDA approval for the pivotal WATER IV PCa trial, outlining study goals, patient criteria, and long-term follow-up plans. Read the press release - FDA Grants Breakthrough Device Designation to Aquablation Therapy for Prostate Cancer
Details about the FDA's decision to fast-track Aquablation as a novel treatment that may improve outcomes for men with localized prostate cancer. Read the announcement - PRCT002: Prostate Cancer Treatment With the AQUABEAM Robotic System
ClinicalTrials.gov entry providing design details, eligibility criteria, and study endpoints for the single-arm feasibility study of Aquablation in prostate cancer. Read on ClinicalTrials.gov - Reimbursement for Aquablation Therapy
Background on current FDA-approved uses of Aquablation for benign prostatic hyperplasia (BPH) and related reimbursement information for U.S. healthcare providers. Read at PROCEPT BioRobotics