Status:
ACTIVE_NOT_RECRUITING
PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System
Lead Sponsor:
PROCEPT BioRobotics
Conditions:
Localized Prostate Cancer
Eligibility:
MALE
40+ years
Phase:
NA
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 assess...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06054867
Start Date
March 11 2024
End Date
April 1 2025
Last Update
August 14 2024
Active Locations (3)
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1
University of Southern California, Institute of Urology
Los Angeles, California, United States, 90033
2
NorthShore University HealthSystem
Glenview, Illinois, United States, 60026
3
NYU Grossman School of Medicine
New York, New York, United States, 10016