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Procedure

Robotic Waterjet Treatment for Prostate Cancer

N/A
Recruiting
Research Sponsored by PROCEPT BioRobotics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Gleason Grade Group 1-3
Cancer stage less than or equal to T2c
Must not have
Patients with previous surgical treatment of benign prostatic hyperplasia
MRI evidence of extracapsular extension of cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post-treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a new robotic system called AQUABEAM for removing prostate tissue in patients with urinary symptoms and localized prostate cancer. Participants will be monitored for up to 12 months to

Who is the study for?
This trial is for men with lower urinary tract symptoms and localized prostate cancer. They must have a symptom score of 8 or higher, certain grades and sizes of cancer lesions, and a PSA level of 15ng/mL or less. The cancer should be at an early stage (T2c or less).
What is being tested?
The AQUABEAM Robotic System, which uses waterjet technology to remove prostate tissue, is being tested for effectiveness and safety in patients with urinary symptoms due to prostate enlargement or cancer.
What are the potential side effects?
Potential side effects may include discomfort during the procedure, bleeding, infection risk post-treatment, temporary urinary issues like difficulty urinating or increased frequency, as well as possible impacts on sexual function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is graded Gleason 1-3.
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My cancer is at an early stage, not beyond T2c.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery for an enlarged prostate.
Select...
My MRI shows my cancer has spread outside its original location.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AquablationExperimental Treatment1 Intervention

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Who is running the clinical trial?

PROCEPT BioRoboticsLead Sponsor
13 Previous Clinical Trials
1,196 Total Patients Enrolled
~31 spots leftby Aug 2025
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