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Procedure

Robotic Waterjet Treatment for Prostate Cancer

N/A
Waitlist Available
Research Sponsored by PROCEPT BioRobotics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prostate volume ≥ 30 ml
Clinical Stage ≤ T2c
Must not have
Radiographically suspicious lymph node involvement confirmed with biopsy or PET scan.
Evidence of bone metastasis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post-treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a robotic system to treat prostate cancer. Participants will be monitored for up to a year.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While specific side effects aren't listed here, similar procedures may include risks such as discomfort at the treatment site, urinary issues like difficulty urinating or infection risk post-treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate is larger than 30 ml.
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My cancer is in an early stage and has not spread widely.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My scans or biopsy confirm I have suspicious lymph node involvement.
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My cancer has spread to my bones.
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My tests show cancer has spread to the seminal vesicles.
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I have received treatment for prostate cancer before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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
Proportion of participants who experience a serious device-related adverse event within 12 months following the study 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
1,299 Total Patients Enrolled
~5 spots leftby Apr 2025
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.
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