Preliminary Effectiveness of Focal US-guided Cryo-ablation Using DynaCAD / UroNAV Preplanning / Guidance of Locally Confined Intermediate Risk Prostate Cancer (Focal Therapy)

• ClinicalTrials.gov Identifier: NCT04656678
• Recruitment Status: Recruiting
• First Posted: December 7, 2020
• Last Update Posted: January 25, 2022
• Sponsor: Northwell Health
• Collaborator: Philips Healthcare
• Information provided by (Responsible Party): Ardeshir Rastinehad, Northwell Health

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer; Prostate Disease	Device: Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: November 25, 2020
• Estimated Primary Completion Date: October 30, 2023
• Estimated Study Completion Date: October 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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. [ Time Frame: 24 months ]
   Incidence and severity of device/treatment related complications from treatment day visit through 24 month follow up.

Secondary Outcome Measures :

1. Assessment of tumor control achieved by treatment. [ Time Frame: 24 months ]
   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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Ardeshir R Rastinehad, DO; 212-434-6580; Arastine@northwell.edu

Contact: Monica K Johnson, RN; 516-734-8515; Mjohnson7@northwell.edu

Locations

United States, New York

The Smith Institute for Urology; Recruiting

Lake Success, New York, United States, 11042

Contact: Monica Johnson, RN 516-734-8515 Mjohnson7@northwell.edu

The Smith Institute for Urology at Lenox Hill; Recruiting

New York, New York, United States, 10022

Contact: Ardeshir Rastinehad, DO 212-434-6580 Arastine@northwell.edu

Manhattan Eye, Ear, and Throat Hospital (MEETH); Recruiting

New York, New York, United States, 10065

Contact: Ardeshir Rastinehad, DO 212-434-6580 Arastine@northwell.edu

Sponsors and Collaborators

Northwell Health

Philips Healthcare

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Ardeshir Rastinehad, Associate Professor of Urology and Radiology, Vice Chair of Urology at Lenox Hill Hospital, System Director for Prostate Cancer, Northwell Health
• ClinicalTrials.gov Identifier: NCT04656678
• Other Study ID Numbers: 20-0562
• First Posted: December 7, 2020
• Last Update Posted: January 25, 2022
• Last Verified: January 2022

• 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

Keywords provided by Ardeshir Rastinehad, Northwell Health:

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

Additional relevant MeSH terms:

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