Focal US-guided Cryo-ablation Using DynaCAD / UroNAV Preplanning / Guidance of Intermediate Risk Prostate Cancer

NCT04656678 | Recruiting DMC FDA Device

• 1 other identifier: 20-0562
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Prostate Cancer; Prostate Disease

Keywords

Prostate MRI; Cryoablation; Focal Therapy; Focal Prostate Cancer Therapy; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Incidence and severity of device/treatment related complications from treatment day visit through 24 month follow up.

  24 months

Secondary Outcomes (1)

• Assessment of tumor control achieved by treatment.

  24 months

Study Arms (1)

DynaCAD / UroNAV

EXPERIMENTAL

This is a single arm study to evaluate feasibility of UroNAV Ablation system aided cryo-ablation treatment of low and intermediate risk, organ-confined prostate cancer. UroNav is a stereotaxic accessory for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and the ability to fuse and register these images with those from other imaging modalities such as Magnetic Resonance (MR), Computed Tomography, etc. It also provides the ability to display a simulated image of a tracked insertion tool on a computer monitor screen that shows images of the target organ and the current and the projected future path of the interventional instrument. DynaCAD 5.0 is an image analysis and planning system that will provide off station, pre planning and review of interventional study data. It interfaces with the Uronav 4.0 fusion guidance system.

Device: Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance

Interventions

Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance DEVICE

Focal ultrasound guided cryoablation using uroNav system Version 4.0 and Dyna CAD software version 5.0.

DynaCAD / UroNAV

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• PSA \< 15 ng/ml or PSA density \< 0.15 ng/ml2 in patients with a PSA \> 15 ng/ml.

You may not qualify if:

• 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
• Claustrophobia
• Implanted ferromagnetic materials or foreign objects
• Known intolerance to the MRI or US contrast agents.
• Severely abnormal coagulation (INR\>1.5)
• Patients with unstable cardiac status including:
• Unstable angina pectoris on medication
• Patients with documented myocardial infarction within 40 days prior to enrolment
• Congestive heart failure NYHA class IV
• Patients with unstable arrhythmia status, already on anti-arrhythmic drugs
• Severe hypertension (diastolic BP \> 100 on medication)
• Severe cerebrovascular disease (multiple CVA or CVA within 6 months)

Sponsors & Collaborators

• Northwell Health: lead
• Philips Healthcare: collaborator

Study Sites (3)

The Smith Institute for Urology

Lake Success, New York, 11042, United States

RECRUITING

The Smith Institute for Urology at Lenox Hill

New York, New York, 10022, United States

RECRUITING

Manhattan Eye, Ear, and Throat Hospital (MEETH)

New York, New York, 10065, United States

RECRUITING

Related Publications (1)

• Jue JS, Coons S, Hautvast G, Thompson SF, Geraats J, Richstone L, Schwartz MJ, Rastinehad AR. Novel Automated Three-Dimensional Surgical Planning Tool and Magnetic Resonance Imaging/Ultrasound Fusion Technology to Perform Nanoparticle Ablation and Cryoablation of the Prostate for Focal Therapy. J Endourol. 2022 Mar;36(3):369-372. doi: 10.1089/end.2021.0266. Epub 2021 Sep 13.

  PMID: 34409850 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Diseases

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ardeshir Rastinehad, DO

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ardeshir R Rastinehad, DO

CONTACT

212-434-6580; Arastine@northwell.edu

Cynthia Knauer, RN

CONTACT

646-874-4733; cknauer1@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology and Radiology, Vice Chair of Urology at Lenox Hill Hospital, System Director for Prostate Cancer

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 7, 2020
• Study Start: November 25, 2020
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: February 2, 2024

Record last verified: 2024-02

Locations

US (3)