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

Primary Purpose

Prostate Cancer, Prostate Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate MRI, Cryoablation, Focal Therapy, Focal Prostate Cancer Therapy, Prostate Cancer

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The Smith Institute for UrologyRecruiting
  • The Smith Institute for Urology at Lenox HillRecruiting
  • Manhattan Eye, Ear, and Throat Hospital (MEETH)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DynaCAD / UroNAV

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 4, 2020
Last Updated
January 27, 2023
Sponsor
Northwell Health
Collaborators
Philips Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT04656678
Brief Title
Focal US-guided Cryo-ablation Using DynaCAD / UroNAV Preplanning / Guidance of Intermediate Risk Prostate Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2020 (Actual)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
Philips Healthcare

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Disease
Keywords
Prostate MRI, Cryoablation, Focal Therapy, Focal Prostate Cancer Therapy, Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DynaCAD / UroNAV
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance
Intervention Description
Focal ultrasound guided cryoablation using uroNav system Version 4.0 and Dyna CAD software version 5.0.
Primary Outcome Measure Information:
Title
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.
Description
Incidence and severity of device/treatment related complications from treatment day visit through 24 month follow up.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Assessment of tumor control achieved by treatment.
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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 PSA < 15 ng/ml or PSA density < 0.15 ng/ml2 in patients with a PSA > 15 ng/ml. 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 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 Severe hypertension (diastolic BP > 100 on medication) Severe cerebrovascular disease (multiple CVA or CVA within 6 months) 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. Patient under medications that can affect PSA for the last 3 months prior to UroNAV Ablation system aided cryo-ablation treatment (Androgen Deprivation Treatment) Patients with lesions of Gleason 7 or greater outside the planned treatment area. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (approximately 3 hrs.) 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). Any spinal pathology which can prevent safe administration of epidural/spinal anesthesia Evidence for lymph node involvement of cancer Bladder cancer Urethral stricture/bladder neck contracture Patients with incontinence demonstrated by use of more than 1 pad/day. . Active UTI Prostatitis NIH categories I, II and III. Compromised renal function Interest in future fertility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ardeshir R Rastinehad, DO
Phone
212-434-6580
Email
Arastine@northwell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Knauer, RN
Phone
646-874-4733
Email
cknauer1@northwell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ardeshir Rastinehad, DO
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Smith Institute for Urology
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Knauer, RN
Phone
646-874-4733
Email
cknauer1@northwell.edu
First Name & Middle Initial & Last Name & Degree
Peter Tricarico
Email
ptricarico1@northwell.edu
Facility Name
The Smith Institute for Urology at Lenox Hill
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ardeshir Rastinehad, DO
Phone
212-434-6580
Email
Arastine@northwell.edu
Facility Name
Manhattan Eye, Ear, and Throat Hospital (MEETH)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ardeshir Rastinehad, DO
Phone
212-434-6580
Email
Arastine@northwell.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
34409850
Citation
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.
Results Reference
derived

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

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