PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System

Sponsor

PROCEPT BioRobotics (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06054867

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

6.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Localized Prostate Cancer	Device: Robotic Waterjet Treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aquablation	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. Other Names: Aquablation therapy

Arm

Intervention/Treatment

Experimental: Aquablation

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.

Other Names:

Aquablation therapy

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California, Institute of Urology	Los Angeles	California	United States	90033
2	NYU Grossman School of Medicine	New York	New York	United States	10016
3	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029