PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

Sponsor

PROCEPT BioRobotics (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06051942

Collaborator

(none)

125

Enrollment

Locations

Arm

41.3

Anticipated Duration (Months)

62.5

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia Localized Prostate Cancer	Device: Robotic Waterjet Treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

125 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

Actual Study Start Date :

Nov 22, 2022

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

May 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aquablation	Device: 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. Other Names: Aquablation therapy

Arm

Intervention/Treatment

Experimental: Aquablation

Device: 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.

Other Names:

Aquablation therapy

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

International Prostate Symptom Score (IPSS) ≥ 8
Gleason Grade Group 1 with ≥3 positive cores or Gleason Grade Group 2-3 with lesions ≤15mm in diameters
Prostate-specific Antigen (PSA) ≤15ng/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