Back to resultsPRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System
Primary Purpose
Localized Prostate Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robotic Waterjet Treatment
Sponsored by
About this trial
This is an interventional other trial for Localized Prostate Cancer focused on measuring AQUABEAM, Aquablation, Aquablation therapy, Robotic Waterjet Treatment, RWT, Prostate cancer
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.
Sites / Locations
- University of Southern California, Institute of Urology
- NYU Grossman School of Medicine
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aquablation
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT06054867
First Posted
September 12, 2023
Last Updated
September 19, 2023
Sponsor
PROCEPT BioRobotics
1. Study Identification
Unique Protocol Identification Number
NCT06054867
Brief Title
PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System
Official Title
PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PROCEPT BioRobotics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Localized Prostate Cancer
Keywords
AQUABEAM, Aquablation, Aquablation therapy, Robotic Waterjet Treatment, RWT, Prostate cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aquablation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Robotic Waterjet Treatment
Other Intervention Name(s)
Aquablation therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of participants who experience a serious device-related adverse event within 12 months following the study treatment.
Description
The primary endpoint is the proportion (percentage) of participants who experience a serious device-related adverse event within 12 months following the study treatment.
Time Frame
12 months post-treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Lee
Phone
650-232-7215
Email
a.lee@procept-biorobotics.com
Facility Information:
Facility Name
University of Southern California, Institute of Urology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ileana Aldana
Phone
323-865-0702
Email
Ileana.aldana@med.usc.edu
Facility Name
NYU Grossman School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dayna Leis, RN
Phone
347-266-2630
Email
Dayna.Leis@nyulangone.org
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monali Fatterpekar
Phone
212-241-0751
Email
monali.fatterpekar@mountsinai.org
12. IPD Sharing Statement
Learn more about this trial
PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System
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