PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System
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.
Conditions:
🦠 Localized Prostate Cancer
🗓️ Study Start (Actual) 11 March 2024
🗓️ Primary Completion (Estimated) April 2025
✅ Study Completion (Estimated) April 2025
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Los Angeles, California, United States
📍 Glenview, Illinois, United States
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 40 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 September 2023
  • First Submitted that Met QC Criteria 19 September 2023
  • First Posted 26 September 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 June 2024
  • Last Update Posted 25 June 2024
  • Last Verified June 2024