Robotic Waterjet Treatment for Prostate Cancer
Recruiting at 4 trial locations
AL
Overseen ByAngela Lee
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: PROCEPT BioRobotics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries
Trial Summary
What is the purpose of this trial?
The goal of this clinical trial is to evaluate the safety of the AQUABEAM Robotic System in treating patients with localized prostate cancer. Participants will go through baseline and follow up assessments up to 12 months.
Eligibility Criteria
Men with localized prostate cancer who haven't had previous treatments for an enlarged prostate in the last year, have a prostate volume of at least 30 ml, PSA levels at or below 20 ng/ml, and are classified as Grade Group 1 or 2. Men with advanced disease like bone metastasis, lymph node involvement confirmed by biopsy/PET scan, extracapsular spread, seminal vesicle invasion or any other serious health risks are not eligible.Inclusion Criteria
My prostate is larger than 30 ml.
My prostate cancer is low grade, and I have 3 or more positive biopsy cores.
My cancer is in an early stage and has not spread widely.
See 1 more
Exclusion Criteria
My scans or biopsy confirm I have suspicious lymph node involvement.
My cancer has spread to my bones.
I had surgery or a minimally invasive treatment for an enlarged prostate in the last year.
See 4 more
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Participants undergo baseline assessments before treatment
1 week
Treatment
Participants receive treatment with the AQUABEAM Robotic System
1 week
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
Treatment Details
Interventions
- AQUABEAM Robotic System
Trial OverviewThe trial is testing the AQUABEAM Robotic System's safety for treating localized prostate cancer. Participants will undergo this robotic waterjet treatment and be monitored through various assessments over a period of up to one year.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: AquablationExperimental Treatment1 Intervention
AQUABEAM Robotic System is already approved in United States for the following indications:
Approved in United States as Aquablation Therapy for:
- Benign Prostatic Hyperplasia (BPH)
- Lower Urinary Tract Symptoms (LUTS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
PROCEPT BioRobotics
Lead Sponsor
Trials
14
Recruited
1,300+
Other People Viewed
By Subject
By Trial
Related Searches
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.