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Active, not recruitingNCT06054867Updated Aug 14, 2024

PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System

An interventional study of Robotic Waterjet Treatment in Localized Prostate Cancer, sponsored by PROCEPT BioRobotics. Active, not recruiting at 3 sites in United States. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-08-14.

Sponsored by PROCEPT BioRobotics · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
40 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Localized Prostate Cancer

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Keywords

  • AQUABEAM
  • Aquablation
  • Aquablation therapy
  • Robotic Waterjet Treatment
  • RWT
  • Prostate cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 22 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

PROCEPT BioRobotics is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Aquablation

    Device: Robotic Waterjet Treatment

Interventions

  • DeviceRobotic 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.

    Also known as: Aquablation therapy

06

What researchers measure

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.

    Time frame: 12 months post-treatment

07

Study locations

3 sites
  • University of Southern California, Institute of Urology
    Los Angeles, California 90033, United States
  • NorthShore University HealthSystem
    Glenview, Illinois 60026, United States
  • NYU Grossman School of Medicine
    New York, New York 10016, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06054867
Lead sponsor
PROCEPT BioRobotics
Responsible party
Sponsor
First posted
Sep 26, 2023
Start date
Mar 11, 2024
Primary completion
Apr 2025 (estimated)
Completion
Apr 2025 (estimated)
Last update
Aug 14, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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