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Focal US-guided Cryo-ablation Using DynaCAD / UroNAV Preplanning / Guidance of Intermediate Risk Prostate Cancer | Clinical Trials | Clareo Health

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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

NCT04656678•Northwell Health

View on ClinicalTrials.gov

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

Eligibility

Age

45 - No limit years

Sex

MALE

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
+1 more criteria

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
+20 more criteria

Locations (3)

The Smith Institute for Urology

Lake Success, New York, United States

The Smith Institute for Urology at Lenox Hill

New York, New York, United States

Manhattan Eye, Ear, and Throat Hospital (MEETH)

New York, New York, United States

Key Dates

Start Date

November 25, 2020

Primary Completion Date

October 30, 2025

Completion Date

October 30, 2025

Last Updated

February 2, 2024

Enrollment

200

ESTIMATED participants

Conditions

Prostate CancerProstate Disease

Interventions

Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance

DEVICE

Contacts

Ardeshir R Rastinehad, DO

CONTACT

212-434-6580 Arastine@northwell.edu

Cynthia Knauer, RN

CONTACT

646-874-4733 cknauer1@northwell.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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