Active — Not RecruitingNot Applicable

PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

United States, Hong Kong, Lebanon125 participantsStarted 2022-11-22

Plain-language 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.

Who can participate

Age range80 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 3 months post-treatment

Trial details

NCT IDNCT06051942

SponsorPROCEPT BioRobotics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07

View on ClinicalTrials.gov More Benign Prostatic Hyperplasia trials