Cryoablation Approach Linked to Shorter Hospitalizations, High Recurrence-Free Rate for Kidney Cancer

Interim results for the cryoablation system, ProSense, show that patients with renal cell carcinoma (RCC) experience shorter hospitalization times and a minor impact on renal function, according to a news release of the ICESECRET trial (NCT02399124) published by the developer, IceCure Medical.¹

The ProSense system, which freezes tumors as opposed to surgically removing them, treats patients with kidneys tumors. The data show that the system was associated with an 89.5% recurrence-free rate. The interim analysis of the ICESECRET kidney cancer trial was presented at the 3rd Annual Israeli Conference on Interventional Radiology in Tel Aviv on June 10, 2024.

“Cryoablation is a safe and effective, minimally invasive ablative approach for treating renal cell carcinoma presenting with tumors 3 [or smaller] centimeters, resulting in shorter hospitalization than nephrectomy and minor side effects on the renal function and on hemoglobin levels. Further studies are needed to confirm cryoablation as a viable option to treat kidney lesions,” Sarel Halachmi, a clinical professor and doctor of medicine in the Department of Urology at the Bnai Zion Medical Center in Haifa, Israel.

In the single-arm, open-label trial, investigators analyzed treatment with IceCure’s ProSense system in patients with RCC (n = ~120).² Primary outcome measures include success in creating an ice ball that engulfs the whole tumor with 5-mm margins as seen under laparoscopic, US, or CT imaging, as well as 5-year recurrence-free survival. A secondary end point is success in verification of safety as displayed through no complications related to the cryoablation procedure other than well-documented ones.

Earlier cryoablation findings were presented on December 14, 2022, at the Urological Association Conference in Eilat, Israel.³ The trial included 115 patients with localized small renal masses 5 cm or smaller treated with ProSense cryoablation under CT guidance. The interim study similarly concluded safety and efficacy for treating renal masses under 5 cm.

Results showed that of the enrolled (n = 115), 107 patients returned for follow-up with a mean duration of 22.8 months (range, 12-60). For the 107 patients, the recurrence-free rate was 85.1%, with 13 patients undergoing a second cryoablation, at a mean follow-up period of 16.5 months.

“These impressive interim results demonstrate the value of ProSense for urologists and interventional radiologists as a therapeutic alternative when patients are not eligible for surgery,” Eyal Shamir, IceCure’s chief executive officer, said in the news release. “We believe the findings will support further use of ProSense in the jurisdictions in which our cryoablation system is approved for use with benign and malignant tissues of the kidney. The growing body of data on ProSense’s efficacy and safety across a broad range of indications supports commercialization momentum, particularly in facilities that benefit from one device that can be used across multiple specialties.”

Additionally, 5 serious AEs were reported; 4 of mild severity resolved within 1 to 5 days and 1 onset of ipsilateral hydronephrosis resulting in nephrectomy 7 months after cryoablation. Cryoablation and hospitalization times took no longer than 25 minutes and 2 days, respectively.

Full engulfment of the renal region with a safety margin of 0.5 cm was achieved in approximately 96% of procedures without anatomical limitation. Safety was determined through study-wide monitoring of procedure-related AEs.

References

1. Positive data from IceCure’s kidney cancer clinical study presented at interventional radiology conference: minimally invasive approach results in shorter hospitalization and minor impact on renal function. News release. IceCure Medical Ltd. June 12, 2024. Accessed June 18, 2024. https://www.prnewswire.com/news-releases/positive-data-from-icecures-kidney-cancer-clinical-study-presented-at-interventional-radiology-conference-minimally-invasive-approach-results-in-shorter-hospitalization-and-minor-impact-on-renal-function-302170565.html
2. Post marketing surveillance for PROSENSE a cryotherapy treatment of renal cell carcinoma (ICE-SECRET). ClincalTrials.gov. Updated March 6, 2024. Accessed June 18, 2024.
3. IceCure’s ProSense safe and effective in treating kidney tumors with 89.5% recurrence-free rate based on interim study results. News release. IceCure Medical Ltd. Published December 19, 2022. Accessed June 18, 2024. https://ir.icecure-medical.com/news-events/press-releases/detail/65/icecures-prosense-safe-and-effective-in-treating-kidney-tumors-with-89-5-recurrence-free-rate-based-on-interim-study-results