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NCT06051942 Clinical Trial

PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

Benign Prostatic Hyperplasia Clinical Trial

Official title:
PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06051942
Other study ID # CSP0003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 22, 2022
Est. completion date May 2026

Study information
Verified date February 2024
Source PROCEPT BioRobotics
Contact Angela Lee
Phone 650-232-7215
Email a.lee@procept-biorobotics.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to assess the performance and safety of the AQUABEAM Robotic System for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (LUTS) and are diagnosed with localized prostate cancer. Participants will go through baseline and follow up assessments up to 12 months.

Recruitment information / eligibility
Status Recruiting
Enrollment 125
Est. completion date May 2026
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender Male
Age group N/A to 80 Years
Eligibility Inclusion Criteria: - International Prostate Symptom Score (IPSS) = 8 - Gleason Grade Group 1-3 - Prostate-specific Antigen (PSA) =20ng/mL - Cancer stage less than or equal to T2c Exclusion Criteria: - Patients with previous surgical treatment of benign prostatic hyperplasia - MRI evidence of extracapsular extension of cancer - Any severe illness that would prevent complete study participation or confound study results

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Robotic Waterjet Treatment
The Aquablation therapy is a minimally invasive, image-guided, heat-free robotic therapy delivered by the AQUABEAM Robotic System. During Aquablation therapy, the AQUABEAM Handpiece is inserted transurethrally into the prostatic urethra. The operating physician then utilizes cystoscopy in conjunction with transrectal ultrasound (TRUS) imaging for real time visualization. The AQUABEAM Robotic System utilizes high-velocity sterile saline waterjet to resect and remove the prostate tissue according to the operating physician's treatment plan.

Locations
Country Name City State
Hong Kong The Chinese University of Hong Kong Hong Kong
Lebanon American University of Beirut Beirut
United States Urology Austin, PLLC Austin Texas
United States NorthShore University HealthSystem Glenview Illinois

Sponsors (1)
Lead Sponsor Collaborator
PROCEPT BioRobotics

Countries where clinical trial is conducted

United States,  Hong Kong,  Lebanon, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment Proportion (percentage) of participants with adverse events rated as related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (ejaculatory disorder, erectile dysfunction, or incontinence) evidenced through 3 months post-treatment. 3 months post-treatment
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