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Prostate CancerNCT04656678

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

A study testing Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance in people with Prostate Cancer and Prostate Disease, run by Northwell Health at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 years and older, men only
Conditions the study is for
Prostate Cancer, Prostate Disease
What is being tested?
Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
3 sitesUnited States
Study dates
25 Nov 2020to 30 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

3 sites in 1 country.

Ardeshir R Rastinehad, DO contact

212-434-6580

Arastine@northwell.edu

Cynthia Knauer, RN contact

646-874-4733

cknauer1@northwell.edu

United States3 sites, 3 recruiting

  • The Smith Institute for Urology

    Lake Success, New York, 11042

    Cynthia Knauer, RN, 646-874-4733, cknauer1@northwell.edu

    Peter Tricarico, ptricarico1@northwell.edu

    Recruiting

  • The Smith Institute for Urology at Lenox Hill

    New York, New York, 10022

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

    Recruiting

  • Manhattan Eye, Ear, and Throat Hospital (MEETH)

    New York, New York, 10065

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

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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

Being tested
Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance
Keywords
Prostate MRI, Cryoablation, Focal Therapy, Focal Prostate Cancer Therapy, Prostate Cancer
Medical subject headings
Prostatic Neoplasms, Prostatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cryo-ablation Using DynaCAD / UroNAV preplanning / guidanceDevice

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

Study groups in NCT04656678
Study groupRoleWhat they receive
DynaCAD / UroNAVExperimentalThis 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.
Receives: Device: Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months

Secondary outcomes (1)

  1. 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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2020
  2. Study start25 Nov 2020
  3. Primary completion30 Oct 2025 (estimated)
  4. Study completion30 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04656678
Sponsor's protocol ID
20-0562
Status last verified
Feb 2024
First submitted
4 Dec 2020
Last updated
2 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

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.

    PubMed 34409850

Questions about this trial

What is this clinical trial studying?

A study testing Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance in people with Prostate Cancer and Prostate Disease, run by Northwell Health at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ardeshir R Rastinehad, DO (212-434-6580, Arastine@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04656678, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.

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