Assessing Aquablation Therapy Outcomes for Prostate Cancer Patients
PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs
NA · PROCEPT BioRobotics · NCT06051942
This study is testing a new robotic water treatment to see if it can safely remove prostate tissue and improve urinary symptoms in men with localized prostate cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | N/A to 80 Years |
| Sex | Male |
| Sponsor | PROCEPT BioRobotics (industry) |
| Locations | 6 sites (La Mesa, California and 5 other locations) |
| Trial ID | NCT06051942 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of the AQUABEAM Robotic System in removing prostate tissue in patients with localized prostate cancer and lower urinary tract symptoms. Participants will undergo assessments at baseline and follow-ups for up to 12 months to monitor outcomes. The intervention involves a robotic waterjet treatment designed to improve urinary symptoms while addressing cancerous tissue.
Who should consider this trial
Good fit: Ideal candidates include men with localized prostate cancer (Gleason Grade Group 1-3) and significant urinary symptoms.
Not a fit: Patients with advanced cancer stages or those who have undergone previous surgical treatments for benign prostatic hyperplasia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a minimally invasive option for patients with localized prostate cancer, potentially improving their quality of life.
How similar studies have performed: Other studies have shown promise with robotic-assisted treatments for prostate conditions, suggesting potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
La Mesa, California and 5 other locations
- San Diego Clinical Trials — La Mesa, California, United States (RECRUITING)
- Endeavour Health (NorthShore University HealthSystem) — Glenview, Illinois, United States (RECRUITING)
- Urology Austin, PLLC — Austin, Texas, United States (NOT_YET_RECRUITING)
- Potomac Urology Center — Alexandria, Virginia, United States (RECRUITING)
- The Chinese University of Hong Kong — Hong Kong, Hong Kong (RECRUITING)
- American University of Beirut — Beirut, Lebanon (RECRUITING)
Study contacts
- Study coordinator: Angela Lee
- Email: a.lee@procept-biorobotics.com
- Phone: 650-232-7215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Benign Prostatic Hyperplasia, Localized Prostate Cancer, AQUABEAM, AQUABEAM Robotic System, Aquablation, Aquablation therapy, Robotic Waterjet Treatment, RWT