PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

PROCEPT BioRobotics

Status: Enrolling

Conditions: Benign Prostatic Hyperplasia; Localized Prostate Cancer

Treatments: Device: Robotic Waterjet Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT06051942

CSP0003

Details and patient eligibility

About

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.

Enrollment: 125 estimated patients

Sex: Male

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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125 participants in 1 patient group

Aquablation

Experimental group

Treatment:

Device: Robotic Waterjet Treatment