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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

Must not have

Very Low Risk Prostate Cancer based on Epstein's Criteria having a tumor <0.2 cc (AUA Guidelines 2017 pg. 9)

Severe hypertension (diastolic BP > 100 on medication)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My prostate cancer is classified as very low risk.

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My blood pressure is very high even with medication.

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I use more than one pad a day due to incontinence.

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My prostate cancer is low grade, my PSA is under 10, and it's minimally spread in the biopsy.

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I have a narrowing in my urethra or bladder neck.

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I have bladder cancer.

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I have a spine condition that makes epidural/spinal anesthesia unsafe.

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I do not have severe heart problems like recent heart attacks or uncontrolled heart failure.

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I have had treatments like surgery or radiation for prostate cancer.

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I can stay still on my back for about 3 hours.

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I have no rectal conditions that could affect ultrasound results or probe insertion.

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I have been diagnosed with a type of prostatitis.

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My cancer has spread to my lymph nodes.

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My kidney function is not normal.

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I currently have a urinary tract infection.

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I have aggressive prostate cancer lesions outside the treatment area.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Assessment of tumor control achieved by treatment.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 23Eligibility criteria met