PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System

PROCEPT BioRobotics

Status

Active, not recruiting

Conditions

Localized Prostate Cancer

Treatments

Device: Robotic Waterjet Treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT06054867

CSP0004

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.