Benign Prostatic Hyperplasia Clinical Trial
Official title:
PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs
NCT number | NCT06051942 |
Other study ID # | CSP0003 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 22, 2022 |
Est. completion date | May 2026 |
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.
Status | Recruiting |
Enrollment | 125 |
Est. completion date | May 2026 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The Chinese University of Hong Kong | Hong Kong | |
Lebanon | American University of Beirut | Beirut | |
United States | Urology Austin, PLLC | Austin | Texas |
United States | NorthShore University HealthSystem | Glenview | Illinois |
Lead Sponsor | Collaborator |
---|---|
PROCEPT BioRobotics |
United States, Hong Kong, Lebanon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 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. | 3 months post-treatment |
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