PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

Study Overview
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Brief Summary
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The goal of this clinical trial is to assess the performance and safety of the AQUABEAM Robotic System for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (LUTS) and are diagnosed with localized prostate cancer. Participants will go through baseline and follow up assessments up to 12 months.

Official Title
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PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

Conditions
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Benign Prostatic Hyperplasia, 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: International Prostate Symptom Score (IPSS) ≥ 8 Gleason Grade Group 1 with ≥3 positive cores or Gleason Grade Group 2-3 with lesions ≤15mm in diameters Prostate-specific Antigen (PSA) ≤15ng/mL Cancer stage less than or equal to T2c Exclusion Criteria: Patients with previous surgical treatment of benign prostatic hyperplasia MRI evidence of extracapsular extension of cancer Any severe illness that would prevent complete study participation or confound study results

Ages Eligible for Study
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Maximum Age: 80 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: Treatment
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 |
| --- | --- | --- |
| Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment | Proportion (percentage) of participants with adverse events rated as related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (ejaculatory disorder, erectile dysfunction, or incontinence) evidenced through 3 months post-treatment. | 3 months post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AQUABEAM, AQUABEAM Robotic System, Aquablation, Aquablation therapy, Robotic Waterjet Treatment, RWT, Prostate cancer, Lower urinary tract symptoms, LUTS, BPH