PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

N/AActive Not RecruitingNCT06051942

PROCEPT BioRobotics125 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

125

Conditions

Benign Prostatic Hyperplasia Localized Prostate Cancer

Interventions

Robotic Waterjet TreatmentDEVICE

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.

Eligibility

Sex: MALEMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (6)

San Diego Clinical Trials

La Mesa, California, United States

Endeavour Health (NorthShore University HealthSystem)

Glenview, Illinois, United States

Potomac Urology Center

Alexandria, Virginia, United States

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

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.

Time frame: 3 months post-treatment

Data from ClinicalTrials.gov

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