PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

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.

AQUABEAM, AQUABEAM Robotic System, Aquablation, Aquablation therapy, Robotic Waterjet Treatment, RWT, Prostate cancer, Lower urinary tract symptoms, LUTS, BPH

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.

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.

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