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OpenTrials
Active, Not Recruiting

NCT Number: NCT06051942

PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Localized Prostate Cancer Lower Urinary Tract Symptoms Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Urological Manifestations

Age range

Up to 80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong, Hong Kong

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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 study results

Treatment and study plan

Robotic Waterjet Treatment

Device

The Aquablation therapy is a minimally invasive, image-guided, heat-free robotic therapy delivered by the AQUABEAM Robotic System. During Aquablation therapy, the AQUABEAM Handpiece is inserted transurethrally into the prostatic urethra. The operating physician then utilizes cystoscopy in conjunction with transrectal ultrasound (TRUS) imaging for real time visualization. The AQUABEAM Robotic System utilizes high-velocity sterile saline waterjet to resect and remove the prostate tissue according to the operating physician's treatment plan.

Other names: Aquablation therapy

Primary outcomes

  1. Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment

    Time frame: 3 months post-treatment

    Proportion (percentage) of participants with adverse events rated as related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (ejaculatory disorder, erectile dysfunction, or incontinence) evidenced through 3 months post-treatment.

Sponsors and collaborators

Lead sponsor

PROCEPT BioRobotics

Industry

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Sep 25, 2023
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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