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Procedure

Cryo-ablation for Prostate Cancer (Focal Therapy Trial)

N/A

Recruiting

Led By Ardeshir Rastinehad, DO

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

PSA < 15 ng/ml or PSA density < 0.15 ng/ml2 in patients with a PSA > 15 ng/ml

Gleason Score ≤ 7; and 2 or less positive lesions on prior MR US fusion guided prostate biopsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Focal Therapy Trial Summary

This trial is testing whether adding the UroNav and DynaCAD software to the standard ultrasound-only prostate cancer treatment is safe and feasible. The software may help doctors locate and treat cancerous areas identified in a previous biopsy.

Who is the study for?

Men over 45 with intermediate-risk prostate cancer, confirmed by MRI-guided biopsies, Gleason Score ≤7, and no more than two lesions. They must understand the study and consent to it. Excluded are those with severe health issues, metastatic disease, rectal or spinal problems that affect treatment safety, very low risk cancer based on specific criteria, contraindications to MRI or certain medications affecting PSA levels.Check my eligibility

What is being tested?

The trial is testing the safety and effectiveness of using UroNav software combined with DynaCAD for planning cryo-ablation treatments in prostate cancer patients. This technology aims to improve upon ultrasound-only methods by better locating tumors identified in previous biopsies for targeted treatment.See study design

What are the potential side effects?

Potential side effects may include discomfort from prolonged supine positioning during treatment (about 3 hours), risks associated with anesthesia used during the procedure, changes in urinary function due to prostate manipulation and possible complications from cryo-ablation such as tissue damage.

Focal Therapy Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My PSA level is below 15 ng/ml or my PSA density is below 0.15 if my PSA is above 15.

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My prostate cancer has a low Gleason score and minimal positive biopsy results.

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My prostate cancer is in early stages and visible on an MRI.

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My cancer has not spread to other parts of my body according to NCCN guidelines.

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My prostate cancer was diagnosed using MRI-guided biopsies.

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I am 45 years old or older.

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My prostate cancer has been confirmed by lab tests.

Focal Therapy Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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.

Secondary outcome measures

Assessment of tumor control achieved by treatment.

Focal Therapy Trial Design

1Treatment groups

Experimental Treatment

Group I: DynaCAD / UroNAVExperimental Treatment1 Intervention

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.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Philips HealthcareIndustry Sponsor

125 Previous Clinical Trials

282,126 Total Patients Enrolled

5 Trials studying Prostate Cancer

1,783 Patients Enrolled for Prostate Cancer

Northwell HealthLead Sponsor

460 Previous Clinical Trials

470,843 Total Patients Enrolled

4 Trials studying Prostate Cancer

466 Patients Enrolled for Prostate Cancer

Ardeshir Rastinehad, DO4.543 ReviewsPrincipal Investigator - Northwell Health

Medical School - New York Institute of Technology, New York College of Osteopathic Medicine, Doctor of Osteopathic Medicine

3 Previous Clinical Trials

2,206 Total Patients Enrolled

2 Trials studying Prostate Cancer

1,686 Patients Enrolled for Prostate Cancer

5Patient Review

great doc. would recommend to a friend.

Media Library

Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04656678 — N/A

Prostate Cancer Research Study Groups: DynaCAD / UroNAV

Prostate Cancer Clinical Trial 2023: Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance Highlights & Side Effects. Trial Name: NCT04656678 — N/A

Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04656678 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being taken on for this medical research project?

"Affirmative. According to the clinical trial's listing on clinicaltrials.gov, it is currently recruiting patients who signed up since November 25th 2020. The study requires 45 individuals from 3 different sites to contribute data."

Answered by AI

Are there any current opportunities to join this clinical investigation?

"Affirmative. Data hosted on clinicaltrials.gov reveals that this research project, which was initially posted on November 25th 2020 is actively looking for participants. A total of 45 patients need to be enrolled from 3 distinct medical centres."

Answered by AI

Recent research and studies

Journal of EndourologyJournal

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

Jue, Joshua S., Samuel Coons, Gilion Hautvast, Scott F. Thompson, Jack Geraats, Lee Richstone, Michael J. Schwartz, and Ardeshir R. Rastinehad. 2022. “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”. Journal of Endourology. Mary Ann Liebert Inc. doi:10.1089/end.2021.0266.

Journal of EndourologyJournal

clinicaltrials.govStudy

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

Ardeshir Rastinehad 2020. "Focal US-guided Cryo-ablation Using DynaCAD / UroNAV Preplanning / Guidance of Intermediate Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04656678.