Clinical trial · Interventional
PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs
NCT06051942CI-TRIAL-00101798active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Prostatic Hyperplasia | Benign Prostatic Hyperplasia | ONTOLOGY_EXACT | 0.98 |
| Localized Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic Waterjet Treatment | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Aquablation
- interventionNames
- Device: Robotic Waterjet Treatment
Primary outcomes (1)
- measure
- Incidence of Clavien-Dindo Adverse Events (Percentage of Participants) Through 3 Months Post Treatment
- timeFrame
- 3 months post-treatment
- description
- 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
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.