PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System

Study Overview
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Brief Summary
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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.

Official Title
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PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System

Conditions
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Localized Prostate Cancer

Intervention / Treatment
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* Device: Robotic Waterjet Treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aquablation<br> | Device: Robotic Waterjet Treatment<br>* 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.<br>* Other names: Aquablation therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AQUABEAM, Aquablation, Aquablation therapy, Robotic Waterjet Treatment, RWT, Prostate cancer