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Procedure

Aquablation 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post-treatment

Awards & highlights

Study 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).Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post-treatment

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment

Trial Design

1Treatment groups

Experimental Treatment

Group I: AquablationExperimental Treatment1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

PROCEPT BioRoboticsLead Sponsor

12 Previous Clinical Trials

914 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this research study currently open and accepting participants?

"Per information on clinicaltrials.gov, this investigation is presently seeking volunteers. The trial was initially listed on November 22nd, 2022 and last revised on February 15th, 2024."

Answered by AI

What is the overall count of participants who are registering for this research?

"Indeed, as per clinicaltrials.gov data, this ongoing trial is actively seeking volunteers. The initial posting date was 22nd November 2022 with the most recent update on 15th February 2024. A total of 125 participants are sought from three designated locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

2022. "PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06051942.

All > Benign Prostatic Hyperplasia > Bph