A Study to Evaluate the Safety and Efficacy of Focal US Guided Cryo-ablation Using DynaCAD / UroNAV Preplanning / Guidance of Locally Confined Low to Intermediate Risk Prostate Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Northwell Health
- Enrollment
- 200
- Locations
- 3
- Primary Endpoint
- Assessment 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.
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Ardeshir Rastinehad
Associate Professor of Urology and Radiology, Vice Chair of Urology at Lenox Hill Hospital, System Director for Prostate Cancer
Northwell Health
Eligibility Criteria
Inclusion Criteria
- •Patients must have documented histological or cytological evidence of tumor(s) of the prostate.
- •Patients must be ≥ 45 years of age.
- •Patients must be able to read, understand and sign an informed consent.
- •Organ confined clinical T1C or clinical T2a prostate cancer that is visualized on MR imaging.
- •Prostate cancer is diagnosed by MR image guided biopsies.
- •Gleason Score ≤ 7; and 2 or less positive lesions on prior MR US fusion guided prostate biopsy.
- •A non MRI visible cancer detected via systematic standard biopsy will not be considered an exclusion condition provided the non-MRI visible cancer is singularly located in the contralateral hemisphere of the prostate; is Gleason 6 cancer; and comprises no more than 6mm linear extent of cancer in a single core on standard biopsy.
- •If any standard biopsy cores are positive on the same hemisphere of the prostate gland, they must be confirmed as likely to form a contiguous lesion with the target lesion detected on MRI and therefore be from the same location in the prostate as MR lesion was biopsied and proven to be cancerous. (e.g., Left/Right, Base, Mid Gland, Apex).
- •Prior mpMRI results dated within 120 days prior to ablation.
- •No metastatic disease as per NCCN guidelines (www.nccn.org) - Bone scan indicated to r/o metastatic disease if clinical T1 and PSA \> 20 or T2 and PSA \> 10
Exclusion Criteria
- •ASA status \> 3
- •Very Low Risk Prostate Cancer based on Epstein's Criteria having a tumor \<0.2 cc (AUA Guidelines 2017 pg. 9)
- •GG1, PSA \< 10 ng/ml, no more than two positive cores and no core \> 50% involvement.
- •Contraindications to MRI
- •3.1 Claustrophobia
- •3.2 Implanted ferromagnetic materials or foreign objects
- •3.3 Known intolerance to the MRI or US contrast agents.
- •3.4 Severely abnormal coagulation (INR\>1.5)
- •Patients with unstable cardiac status including:
- •4.1 Unstable angina pectoris on medication
Outcomes
Primary Outcomes
Assessment 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.
Time Frame: 24 months
Incidence and severity of device/treatment related complications from treatment day visit through 24 month follow up.
Secondary Outcomes
- Assessment of tumor control achieved by treatment.(24 months)