WATER IV Prostate Cancer, Rev. B
Research type
Research Study
Full title
WATER IV Prostate Cancer: Aquablation versus Radical Prostatectomy for the Treatment of Localized Prostate Cancer
IRAS ID
350129
Contact name
Angela Lee
Contact email
Sponsor organisation
Procept BioRobotics
Clinicaltrials.gov Identifier
Duration of Study in the UK
11 years, 1 months, 1 days
Research summary
According to Cancer Research UK, in the UK more than 55,000 men are diagnosed with prostate cancer every year and more than 12,000 men die from prostate cancer every year. Most cases of prostate cancer are localised, meaning the cancer is entirely within the prostate gland. Standard treatments range from active surveillance/monitoring of the cancer to treatments such as radiation and radical prostatectomy (surgical removal of the entire prostate gland), depending on the risk level of the cancer.
Active surveillance/monitoring is often used when the disease is found early and is not yet threatening. No anti-cancer treatment occurs initially. The cancer is followed closely, and radical therapy only happens if the disease beings to progress. This delays radical therapy and, if the disease never progresses, avoids it all together. Radical prostatectomy and radiation treatment treat the cancer aggressively but are not without risk and have been associated with both short- and long-term urinary incontinence and erectile dysfunction.
The AQUABEAM Robotic System developed by PROCEPT BioRobotics, is a device that is on the market and standardly-used to treat a different condition called benign prostatic hyperplasia (BPH). The device is a robotic surgical system that uses a high-velocity sterile saline waterjet to remove prostate tissue during a procedure called Aquablation therapy, that is minimally invasive and has less side effects when used in this surgery when compared to other surgical methods. The device is not approved or used for the treatment or management of prostate cancer as this device is investigational for that use. The purpose of this clinical trial is to evaluate the safety and efficacy of Aquablation therapy with the AQUABEAM Robotic System in treatment of localised prostate cancer by determining if treatment side effects are reduced in patients undergoing Aquablation therapy compared to radical prostatectomy.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
24/EE/0281
Date of REC Opinion
5 Mar 2025
REC opinion
Further Information Favourable Opinion