Aquablation Therapy vs Radical Prostatectomy for Prostate Cancer (WATER IV PCa Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Male

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: PROCEPT BioRobotics

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a multicenter, prospective, randomized clinical trial that aims to assess the safety and efficacy of Aquablation Therapy in men with low-risk to intermediate to high-risk localized prostate cancer who are candidates for, or have opted for, prostatectomy. Participants will be randomized to either Aquablation Therapy or radical prostatectomy and followed up to 10 years.

Eligibility Criteria

This trial is for men with low to high-risk localized prostate cancer who are candidates for or have chosen to undergo prostatectomy. Specific eligibility criteria details were not provided.

Inclusion Criteria

I am a man aged 45 or older.

My prostate is larger than 25 ml.

My prostate cancer is in the early stages (Grade Group 1-3).

My cancer is in an early stage and has not grown deeply into nearby tissues.

Exclusion Criteria

I have had treatments for prostate cancer, such as surgery or hormone therapy.

My cancer has spread to my lymph nodes, bones, or seminal vesicles.

I am not willing to receive a blood transfusion.

I am able to understand and willing to follow the study's requirements.

Treatment Details

The study compares Aquablation Therapy, a minimally invasive waterjet treatment, with the traditional surgical method of radical prostatectomy in treating prostate cancer over up to a decade.

2Treatment groups

Experimental Treatment

Active Control

Group I: Aquablation TherapyExperimental Treatment1 Intervention

The Aquablation Therapy arm will receive Aquablation with either the AQUABEAM Robotic System or HYDROS Robotic System

Group II: Radical ProstatectomyActive Control1 Intervention

The radical prostatectomy arm will receive the standard of care radical prostatectomy procedure.