PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System

Last updated: August 12, 2024
Sponsor: PROCEPT BioRobotics
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Prostate Cancer, Early, Recurrent

Prostate Cancer

Prostate Disorders

Treatment

Robotic Waterjet Treatment

Clinical Study ID

NCT06054867
CSP0004
  • Ages > 40
  • Male

Study 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.

Eligibility Criteria

Inclusion

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, multiplepositive from any MRI targeted lesion will be considered as a single positive core.

Exclusion

Exclusion Criteria:

  • Any prior or current treatment for prostate cancer, including but not limited tosurgery, radiation therapy (external or brachytherapy), tissue ablation orchemotherapy.

  • Patients with previous surgical or minimally invasive treatment of benign prostatichyperplasia within the prior 12 months.

  • Radiographically suspicious lymph node involvement confirmed with biopsy or PETscan.

  • 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 tomen undergoing the Aquablation procedure.

Study Design

Total Participants: 22
Treatment Group(s): 1
Primary Treatment: Robotic Waterjet Treatment
Phase:
Study Start date:
March 11, 2024
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • University of Southern California, Institute of Urology

    Los Angeles, California 90033
    United States

    Site Not Available

  • San Diego Clinical Trials

    San Diego, California 91942
    United States

    Site Not Available

  • NorthShore University HealthSystem

    Glenview, Illinois 60026
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • NYU Grossman School of Medicine

    New York, New York 10016
    United States

    Site Not Available

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