PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs
Status
RECRUITING
Phase
NA
Age
All Ages
Enrollments
125Conditions
Benign Prostatic Hyperplasia, Localized Prostate CancerSummary
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.
Locations
3 locations Found with status Recruiting
Eligibility Criteria
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 Plan
Aquablation
DEVICE:
Robotic Waterjet TreatmentDescription:
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.
Outcome Measures
Primary Outcome Measures
Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment
Timeline
Last Updated
November 19, 2024Start Date
September 25, 2023Today
January 16, 2025Completion Date ( Estimated )
May 1, 2026
Sponsors of this trial
Lead Sponsor
PROCEPT BioRobotics
RECRUITING 
21 - 64 Years