PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System

NCT06054867 | Active Not Recruiting FDA Device

• 1 other identifier: CSP0004
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

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

Keywords

AQUABEAM; Aquablation; Aquablation therapy; Robotic Waterjet Treatment; RWT; Prostate cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who experience a serious device-related adverse event within 12 months following the study treatment.

  The primary endpoint is the proportion (percentage) of participants who experience a serious device-related adverse event within 12 months following the study treatment.

  12 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: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PROCEPT BioRobotics: lead

Study Sites (3)

University of Southern California, Institute of Urology

Los Angeles, California, 90033, United States

Location

NorthShore University HealthSystem

Glenview, Illinois, 60026, United States

Location

NYU Grossman School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

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

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 26, 2023
• Study Start: March 11, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

US (3)