Prostate cancer Prostatic neoplasm
Conditions
Interventions
Ablation with IRE will be performed using similar planning criteria, procedure
protocol, instruments and software used for brachytherapy, a conventional
targeted radiation therapy where radioactive
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Life expectancy > 10 years 2. Histologically confirmed organ-confined prostate cancer (clinical stage T1-T2) 3. Gleason score *7 4. PSA
Exclusion criteria
Exclusion criteria: 1. Other Conditions/Status: a) Bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds, partial thromboplastin time (PTT) > 34 seconds, and Platelet Count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) To determine if the IRE ablation procedure is safe as measured by the composite number of procedural, device and post procedural adverse events measured with the CTCAE proforma. b) To determine if complete ablation of the specified targeted ablation zone is achieved as measured by histopathology assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| a) To determine if procedural side effects associated with current treatments for prostate cancer, mainly incontinence, erectile dysfunction and bowel damage are avoided as measured by the validated prostate cancer scores *EPIC, IIEF-5 and IPSS or time of CAD required. b) To determine patient satisfaction and comfort measured by Patient Satisfaction Questionnaire, post procedural pain management and pain scores, time to ambulation, length of hospital stay. c) To determine accurateness of ablation zone detection by MRI/CEUS. | — |
Countries
Netherlands
Outcome results
None listed