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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
Prostate volume ≥ 30 ml
Clinical Stage ≤ T2c
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post-treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My prostate is larger than 30 ml.
Select...
My cancer is in an early stage and has not spread widely.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants who experience a serious device-related adverse event within 12 months following the study 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
12 Previous Clinical Trials
1,019 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies available for this research experiment?
"This clinical trial, which was initially posted on October 1st 2023 and last modified on September 19th of the same year, is no longer recruiting participants. Nevertheless, there are still 1277 medical trials open to potential volunteers at this moment in time."
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