PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

NCT06051942 | Active Not Recruiting FDA Device

• 1 other identifier: CSP0003
• Study Type: interventional
• Target: 125
• Locations: 4 countries
• Sites: 6

Brief 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.

Conditions

Benign Prostatic Hyperplasia; Localized Prostate Cancer

Keywords

AQUABEAM; AQUABEAM Robotic System; Aquablation; Aquablation therapy; Robotic Waterjet Treatment; RWT; Prostate cancer; Lower urinary tract symptoms; LUTS; BPH

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Aquablation

EXPERIMENTAL

Device: Robotic Waterjet Treatment

Interventions

Robotic Waterjet Treatment DEVICE

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.

Also known as: Aquablation therapy

Aquablation

Eligibility Criteria

• Age: Up to 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PROCEPT BioRobotics: lead

Study Sites (6)

San Diego Clinical Trials

La Mesa, California, 91942, United States

Location

Endeavour Health (NorthShore University HealthSystem)

Glenview, Illinois, 60026, United States

Location

Potomac Urology Center

Alexandria, Virginia, 22311, United States

Location

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

American University of Beirut

Beirut, Lebanon

Location

Tauranga Urology Research Ltd

Tauranga, New Zealand

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Prostatic Neoplasms; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: November 22, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

US (3); LE (1); HK (1); NZ (1)