Clinical trial · Interventional
PRCT002 PRostate Cancer Treatment With the AQUABEAM Robotic System
NCT06054867CI-TRIAL-00079816unknownN/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 evaluate the safety of the AQUABEAM Robotic System in treating patients with localized prostate cancer. Participants will go through baseline and follow up assessments up to 12 months.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 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
- Proportion of participants who experience a serious device-related adverse event within 12 months following the study treatment.
- timeFrame
- 12 months post-treatment
- description
- The primary endpoint is the proportion (percentage) of participants who experience a serious device-related adverse event within 12 months following the study treatment.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical Stage ≤ T2c * PSA ≤ 20 ng/ml * Prostate volume ≥ 30 ml * Grade Group (GG) 1 or 2: If GG 1: ≥ 3 cores positive for cancer. Note, multiple positive from any MRI targeted lesion will be considered as a single positive core. Exclusion Criteria: * Any prior or current treatment for prostate cancer, including but not limited to surgery, radiation therapy (external or brachytherapy), tissue ablation or chemotherapy. * Patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 12 months. * Radiographically suspicious lymph node involvement confirmed with biopsy or PET scan. * Evidence of bone metastasis. * Evidence of extracapsular involvement. * Evidence of seminal vesicle invasion on DRE or MRI read as "definite", "probable" or "consistent with" * Any condition or history of illness or surgery that may pose an additional risk to men undergoing the Aquablation procedure.
References
Publications (0)
Data not yet available
No reference posted for this study.