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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Prostate Disease
• Intervention / Treatment: Device: Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance

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

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cynthia Knauer, RN; Phone Number: 646-874-4733; Email: cknauer1@northwell.edu
• Study Contact Backup: Name: Ardeshir R Rastinehad, DO; Phone Number: 212-434-6580; Email: Arastine@northwell.edu

Study Locations

• United States
  • New York
    • Lake Success, New York, United States, 11042
      • Recruiting
      • The Smith Institute for Urology
      • Contact: Cynthia Knauer, RN; Phone Number: 646-874-4733; Email: cknauer1@northwell.edu
      • Contact: Peter Tricarico; Email: ptricarico1@northwell.edu
    • New York, New York, United States, 10022
      • Recruiting
      • The Smith Institute for Urology at Lenox Hill
      • Contact: Ardeshir Rastinehad, DO; Phone Number: 212-434-6580; Email: Arastine@northwell.edu
    • New York, New York, United States, 10065
      • Recruiting
      • Manhattan Eye, Ear, and Throat Hospital (MEETH)
      • Contact: Ardeshir Rastinehad, DO; Phone Number: 212-434-6580; Email: Arastine@northwell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients must have documented histological or cytological evidence of tumor(s) of the prostate.
2. Patients must be ≥ 45 years of age.
3. Patients must be able to read, understand and sign an informed consent.
4. Organ confined clinical T1C or clinical T2a prostate cancer that is visualized on MR imaging.
5. Prostate cancer is diagnosed by MR image guided biopsies.
6. Gleason Score ≤ 7; and 2 or less positive lesions on prior MR US fusion guided prostate biopsy.
7. 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.
8. 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).
9. Prior mpMRI results dated within 120 days prior to ablation.
10. 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
11. PSA < 15 ng/ml or PSA density < 0.15 ng/ml2 in patients with a PSA > 15 ng/ml.

Exclusion Criteria:

1. ASA status > 3

2. 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.

3. 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)

4. Patients with unstable cardiac status including:

   4.1 Unstable angina pectoris on medication

   4.2 Patients with documented myocardial infarction within 40 days prior to enrolment

   4.3 Congestive heart failure NYHA class IV

   4.4 Patients with unstable arrhythmia status, already on anti-arrhythmic drugs

5. Severe hypertension (diastolic BP > 100 on medication)
6. Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
7. History of orchiectomy, PCa-specific chemotherapy, brachytherapy, cryotherapy, Photodynamic therapy or radical prostatectomy for treatment of prostate cancer; any prior radiation therapy to the pelvis for prostate cancer or any other malignancy.
8. Patient under medications that can affect PSA for the last 3 months prior to UroNAV Ablation system aided cryo-ablation treatment (Androgen Deprivation Treatment)
9. Patients with lesions of Gleason 7 or greater outside the planned treatment area.
10. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (approximately 3 hrs.)
11. Any rectal pathology, anomaly or previous treatment, which could change acoustic properties of rectal wall or prevent safe US probe insertion (e.g., fistula, stenosis, fibrosis, inflammatory bowel disease, etc).
12. Any spinal pathology which can prevent safe administration of epidural/spinal anesthesia
13. Evidence for lymph node involvement of cancer
14. Bladder cancer
15. Urethral stricture/bladder neck contracture
16. Patients with incontinence demonstrated by use of more than 1 pad/day. .
17. Active UTI
18. Prostatitis NIH categories I, II and III.
19. Compromised renal function
20. Interest in future fertility
21. Current participation in another clinical investigation of a medical device or a drug or has participated in such a study within 30 days prior to study enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: DynaCAD / UroNAV; 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; Focal ultrasound guided cryoablation using uroNav system Version 4.0 and Dyna CAD software version 5.0.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: Philips Healthcare
• Investigators: Principal Investigator: Ardeshir Rastinehad, DO, Northwell Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2020
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Prostate Cancer; Cryoablation; Focal Therapy; Prostate MRI; Focal Prostate Cancer Therapy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Prostatic Diseases
• Other Study ID Numbers: 20-0562

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes