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Clinical Trials in the USA / NCT06051942
Active, not recruiting Not applicable

PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

NCT06051942 · tracked via the Priya Life Science USA tracker
Sponsor
PROCEPT BioRobotics
Phase
Not applicable
Started
2022-11-22
Last updated
2026-01-28

Condition(s) studied

Benign Prostatic HyperplasiaLocalized Prostate Cancer

Investigational drug(s) / intervention(s)

Robotic Waterjet Treatment

Robotic Waterjet Treatment: 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.

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

Sex
MALE
Min age
—
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (6)

FacilityCityRegionStatus
San Diego Clinical Trials La Mesa California
Endeavour Health (NorthShore University HealthSystem) Glenview Illinois
Potomac Urology Center Alexandria Virginia
The Chinese University of Hong Kong Hong Kong Hong Kong
American University of Beirut Beirut Lebanon
Tauranga Urology Research Ltd Tauranga New Zealand

More PROCEPT BioRobotics trials in the USA

WATER IV PCa (AS Sub-study) Recruiting
WATER IV Prostate Cancer Active, not recruiting

Other trials for the same condition

Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study Recruiting
Sonablate HIFU International Registry for PC & BPH Patients Recruiting
Expander-2 Trial: Randomized Study to Evaluate Safety & Efficacy of the Urocross® Expander System & Retrieval Sheath Active, not recruiting
WATER IV PCa (AS Sub-study) Recruiting
A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06051942 on ClinicalTrials.gov ↗ ← All trials in the USA