PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- PROCEPT BioRobotics
- Enrollment
- 125
- Locations
- 8
- Primary Endpoint
- Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 80 Years (Child, Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •International Prostate Symptom Score (IPSS) ≥ 8
- •Gleason Grade Group 1-3
- •Prostate-specific Antigen (PSA) ≤20ng/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
Arms & Interventions
Aquablation
Intervention: Robotic Waterjet Treatment (Device)
Outcomes
Primary Outcomes
Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported