Benign Prostatic Hyperplasia, Localized Prostate Cancer
Conditions
Keywords
AQUABEAM, AQUABEAM Robotic System, Aquablation, Aquablation therapy, Robotic Waterjet Treatment, RWT, Prostate cancer, Lower urinary tract symptoms, LUTS, BPH
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.
Interventions
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.
Sponsors
PROCEPT BioRobotics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
No minimum to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Hong Kong, Lebanon, New Zealand, United States
Outcome results
None listed