PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System

Localized Prostate Cancer Clinical Trial

Official title:

PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06054867
• Other study ID #: CSP0004
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: PROCEPT BioRobotics
• Contact: Angela Lee
• Phone: 650-232-7215
• Email: a.lee[@]procept-biorobotics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Localized Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	NorthShore University HealthSystem	Glenview	Illinois
United States	University of Southern California, Institute of Urology	Los Angeles	California
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	NYU Grossman School of Medicine	New York	New York
United States	San Diego Clinical Trials	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
PROCEPT BioRobotics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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