PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

Not Applicable

Recruiting

• Conditions: Benign Prostatic Hyperplasia; Localized Prostate Cancer
• Interventions: Device: Robotic Waterjet Treatment

• Registration Number: NCT06051942
• Lead Sponsor: PROCEPT BioRobotics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-22
• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-09-18
• Study First Posted: 2023-09-25
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19
• Primary Completion: 2025-08
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aquablation	Robotic Waterjet Treatment	-

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (6)

Urology Austin, PLLC; 🇺🇸 Austin, Texas, United States

Endeavour Health (NorthShore University HealthSystem); 🇺🇸 Glenview, Illinois, United States

Potomac Urology Center; 🇺🇸 Alexandria, Virginia, United States

San Diego Clinical Trials; 🇺🇸 La Mesa, California, United States

The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong

American University of Beirut; 🇱🇧 Beirut, Lebanon