Localized Prostate Cancer
Conditions
Keywords
AQUABEAM, Aquablation, Aquablation therapy, Robotic Waterjet Treatment, RWT, Prostate cancer
Brief summary
The goal of this clinical trial is to evaluate the safety of the AQUABEAM Robotic System in treating patients 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
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical Stage ≤ T2c * PSA ≤ 20 ng/ml * Prostate volume ≥ 30 ml * Grade Group (GG) 1 or 2: If GG 1: ≥ 3 cores positive for cancer. Note, multiple positive from any MRI targeted lesion will be considered as a single positive core.
Exclusion criteria
* Any prior or current treatment for prostate cancer, including but not limited to surgery, radiation therapy (external or brachytherapy), tissue ablation or chemotherapy. * Patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 12 months. * Radiographically suspicious lymph node involvement confirmed with biopsy or PET scan. * Evidence of bone metastasis. * Evidence of extracapsular involvement. * Evidence of seminal vesicle invasion on DRE or MRI read as definite, probable or consistent with * Any condition or history of illness or surgery that may pose an additional risk to men undergoing the Aquablation procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who experience a serious device-related adverse event within 12 months following the study treatment. | 12 months post-treatment | The primary endpoint is the proportion (percentage) of participants who experience a serious device-related adverse event within 12 months following the study treatment. |
Countries
United States
Outcome results
None listed