PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

Last updated: November 15, 2024
Sponsor: PROCEPT BioRobotics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Bladder Disorders

Prostate Cancer, Early, Recurrent

Treatment

Robotic Waterjet Treatment

Clinical Study ID

NCT06051942
CSP0003
  • Ages < 80
  • Male

Study Summary

The goal of this clinical trial is to assess the performance and safety of the AQUABEAM Robotic System for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (LUTS) and are diagnosed with localized prostate cancer. Participants will go through baseline and follow up assessments up to 12 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • International Prostate Symptom Score (IPSS) ≥ 8

  • Gleason Grade Group 1-3

  • Prostate-specific Antigen (PSA) ≤20ng/mL

  • Cancer stage less than or equal to T2c

Exclusion

Exclusion Criteria:

  • Patients with previous surgical treatment of benign prostatic hyperplasia

  • MRI evidence of extracapsular extension of cancer

  • Any severe illness that would prevent complete study participation or confound studyresults

Study Design

Total Participants: 125
Treatment Group(s): 1
Primary Treatment: Robotic Waterjet Treatment
Phase:
Study Start date:
November 22, 2022
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • The Chinese University of Hong Kong

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • American University of Beirut

    Beirut,
    Lebanon

    Active - Recruiting

  • San Diego Clinical Trials

    La Mesa, California 91942
    United States

    Active - Recruiting

  • Endeavour Health (NorthShore University HealthSystem)

    Glenview, Illinois 60026
    United States

    Active - Recruiting

  • NorthShore University HealthSystem

    Glenview, Illinois 60026
    United States

    Active - Recruiting

  • Urology Austin, PLLC

    Austin, Texas 78745
    United States

    Site Not Available

  • Potomac Urology Center

    Alexandria, Virginia 22311
    United States

    Active - Recruiting

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