PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

Condition(s) studied

Investigational drug(s) / intervention(s)

Robotic 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment — 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.

Trial sites (6)

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