This trial is looking to examine the use of a new treatment software (UroNAV Ablation) system in treating confined prostate cancer with cryoablation. The main outcomes to be measured will be device/treatment-related complications and tumor control. This trial is being carried out in New York, US.
Localized prostate cancer has not spread outside the prostate gland. There are many treatment options for localized prostate cancer. Cryoablation is one option. Cryoablation uses extreme cold to destroy cancer cells.
The UroNAV Ablation system uses ultrasound to provide 2D and 3D images of the prostate. This software can allow for precision imaging that can be used in guiding therapy to reduce damage to surrounding tissues. Images are analyzed with the help of the DynaCAD 5.0 software to plan the procedure.
This study will evaluate the DynaCAD 5.0/UroNAV Ablation system for the cryoablation of the prostate in patients with localized prostate cancer. The main outcomes to be measured will be treatment-related complications and tumor control.
Who are they looking for?
This trial is looking to recruit 45 patients with confined prostate cancer. To be included in this trial patients must have previous magnetic resonance imaging (MRI)-guides biopsies (tissue samples).
Patients will be excluded if they have a poor heart function, severe high-blood pressure, or if they have received previous treatment for prostate cancer. Patients who cannot undergo MRI will also be excluded. Patients with issues of the rectum or of the spine, those with kidney or urinary tract disease, and who are planning to have children cannot participate.
How will it work
All patients will undergo ultrasound-guided cryoablation using the UroNav system Version 4.0 and Dyna CAD software version 5.0.
Patients will be followed up using questionnaires, MRIs and blood tests for 24 months to monitor for any side effects and tumor control.