Presented by: Peter Tricarico Clinical Research Coordinator
Northwell Health

Introduction

The urologic landscape for prostate cancer has transitioned to image-based approach using mpMRI of the prostate for patients at risk for prostate cancer. Combining MRI with MR/US fusion technology aids in creating an optimal and accurate plan for both biopsies and focal therapy. This study details using UroNav software (v 4.0) and DynaCAD software (v 5.0) to perform cryoablation of prostate cancer in men with localized prostate cancer diagnosed using MR/US fusion guided prostate biopsies.

Materials

A prospective, single-center clinical trial was conducted, evaluating the use of the UroNav 4.0 and DynaCAD 5.0 Urology systems as adjunctive software tool during ultrasound-guided cryoablation of the prostate. 37 men with focal MRI visible Gleason Grade ≤ 3 undergoing focal cryoablation were included. 

The primary endpoint was to determine safety of UroNAV Ablation system-aided cryo-ablation for focal treatment of low to intermediate-risk MR visible disease. Incidence and severity of device/treatment-related complications were evaluated from the treatment day visit through the 24-month follow-up. The secondary endpoints included results of a 12-month MR/US fusion-guided prostate biopsy with a standard 12-core biopsy template. Metrics for oncologic and clinical success included serial PSAs, interval MRI assessments, post-ablation prostate biopsy (pBx), International Prostate Symptom Score (IPSS), Sexual Health Inventory for Men (SHIM), and the Expanded Prostate Cancer Index Composite short form 26 (EPIC 26) scores.

Results

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To date, 18 subjects have completed the 12-month post-therapy follow-up visit. 17 patients underwent MR/US fusion-guided post-ablation prostate biopsy 12 months post-therapy. 16 subjects did not have recurrent disease (94%). 1 subject had recurrent GG2 disease (6%). PSA values had a significant decrease confirming a biochemical response. IPSS, SHIM, and EPIC scores were not clinically significant, indicating that the treatment is not causing adverse effects [Table 1].

Conclusion

The MR/US fusion technology is a potentially more accurate method to focally treat localized prostate cancer compared to a typical cognitive approach using ultrasound only. The UroNav and DynaCAD systems provide a safe, effective, and streamlined process that allows for precise focal cryoablation of the prostate in men with localized prostate cancer. 

Funding

None

Lead Authors

Thomas Williams, Chief Resident
Northwell Health

Karen Huang, Clinical Data Analyst
Northwell Health

Tavya Benjamin, Fellow, MD
Northwell Health

Cynthia Knauer, RN
Northwell Health

Scott Thompson,
Philips

Samuel Coons,
Philips

Michael Schwartz, MD
Northwell Health

Ardeshir Rastinehad, DO
Northwell Health