The purpose of this research study is to determine the safety and feasibility of using the UroNav software and DynaCAD software for planning and treating prostate cancer as an add on to the already approved workflow of using ultrasound only during the cryoablation of the prostate. The software application may aid doctors in locating a prior biopsy proven cancer location from the UroNav biopsy that patients previously had and then use that information to guide the treatment.
This is a single-center, prospective, single arm study to evaluate feasibility of UroNAV Ablation system aided cryo-ablation treatment of low and intermediate risk, organ-confined prostate cancer. All subjects will be treated and then followed up clinically for up to 24 months to evaluate any procedure or device related adverse events as well as to assess efficacy endpoints of the study. Additional data related to quality of life of treated subjects will also be collected
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Focal ultrasound guided cryoablation using uroNav system Version 4.0 and Dyna CAD software version 5.0.
The Smith Institute for Urology
Lake Success, New York, United States
RECRUITINGThe Smith Institute for Urology at Lenox Hill
New York, New York, United States
RECRUITINGManhattan Eye, Ear, and Throat Hospital (MEETH)
New York, New York, United States
RECRUITINGAssessment of safety of the DynaCAD /UroNAV ablation planning and guidance system aided cryo-ablation in the treatment of low-intermediate risk, localized (organ confined) prostate cancer tumors.
Incidence and severity of device/treatment related complications from treatment day visit through 24 month follow up.
Time frame: 24 months
Assessment of tumor control achieved by treatment.
Primary effectiveness analyses will be based on the 12-month biopsy results. Post-treatment PSA, non-perfused volume (NPV) by multi-parametric MRI, and EPIC - 26 (The Expanded Prostate Cancer Index Composite) questionnaire results through Month 24 visit will be summarized as secondary measures of effectiveness.
Time frame: 24 months
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