PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System

NCT ID: NCT06054867

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-11
• Study Completion Date: 2025-04-30

Brief Summary

The goal of this clinical trial is to evaluate the safety of the AQUABEAM Robotic System in treating patients with localized prostate cancer. Participants will go through baseline and follow up assessments up to 12 months.

Conditions

Localized Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Aquablation

Group Type: EXPERIMENTAL

Robotic Waterjet Treatment

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Aquablation therapy

Eligibility Criteria

Inclusion Criteria

• Clinical Stage ≤ T2c
• PSA ≤ 20 ng/ml
• Prostate volume ≥ 30 ml
• Grade Group (GG) 1 or 2: If GG 1: ≥ 3 cores positive for cancer. Note, multiple positive from any MRI targeted lesion will be considered as a single positive core.

Exclusion Criteria

• Any prior or current treatment for prostate cancer, including but not limited to surgery, radiation therapy (external or brachytherapy), tissue ablation or chemotherapy.
• Patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 12 months.
• Radiographically suspicious lymph node involvement confirmed with biopsy or PET scan.
• Evidence of bone metastasis.
• Evidence of extracapsular involvement.
• Evidence of seminal vesicle invasion on DRE or MRI read as "definite", "probable" or "consistent with"
• Any condition or history of illness or surgery that may pose an additional risk to men undergoing the Aquablation procedure.

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

PROCEPT BioRobotics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Southern California, Institute of Urology

Los Angeles, California, United States

NorthShore University HealthSystem

Glenview, Illinois, United States

NYU Grossman School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

CSP0004

Identifier Type: -

Identifier Source: org_study_id