PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System

Not Applicable

Active, not recruiting

• Conditions: Localized Prostate Cancer
• Interventions: Device: Robotic Waterjet Treatment

• Registration Number: NCT06054867
• Lead Sponsor: PROCEPT BioRobotics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-26
• Study Start: 2024-03-11
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-14
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aquablation	Robotic Waterjet Treatment	-

Primary Outcome Measures

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

Trial Locations

Locations (3)

NYU Grossman School of Medicine; 🇺🇸 New York, New York, United States

University of Southern California, Institute of Urology; 🇺🇸 Los Angeles, California, United States

NorthShore University HealthSystem; 🇺🇸 Glenview, Illinois, United States