PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Localized Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California, Institute of Urology, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robotic Waterjet Treatment

Device

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

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

PROCEPT BioRobotics

Industry

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Sep 26, 2023
Registry last updated: Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting