ProSense® Cryoablation Satisfies Patients With Breast Cancer vs Alternatives

THERMAC trial results revealed that the ProSense® cryoablation system showed no complications, and the highest complete ablation rate in breast cancer.

The ProSense® cryoablation system achieved the highest complete ablation rate compared with alternatives, with 95% of patients with breast cancer being “very satisfied” or “satisfied” with the thermal ablation, according to a press release from the developer, IceCure Medical.1

The results came from the phase 2 THERMAC trial, which compared radiofrequency ablation, microwave ablation, and cryoablation with ProSense® in patients with early-stage breast cancer and were shown in 2 separate publications. The first was published in the European Journal of Surgical Oncology (EJSO) and covered cosmetic outcomes and patient satisfaction with ProSense® in early-stage breast cancer.2 The second was published in Radiology and covered the trial’s efficacy.3

"These peer-reviewed publications further advance ProSense®'s clinical validation," said Eyal Shamir, chief executive officer at IceCure Medical, in the release.1 "In the THERMAC Trial, ProSense® cryoablation outperformed alternative thermal ablation techniques and delivered cosmetic outcomes superior to surgery, showcasing its safety and efficacy in early-stage breast cancer. We are grateful to Sophie Wooldrik, MD and her team in the Netherlands for their rigorous research and interest in evaluating minimally invasive modalities."

ProSense® is a minimally invasive treatment option that destroys tumors by freezing them, utilizing liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction. It may be used in the breast, kidney, lung, and liver to remove benign and cancerous lesions.

The EJSO Paper

The overall median cosmetic outcome was good after thermal ablation, and intermediate after surgery (1.6 vs 1.8; P = .07). Notably, most domains of BREAST-Q were scored higher following thermal ablation compared with breast conserving surgery; 95% of patients were very satisfied or satisfied with thermal ablation, and 91% preferred thermal ablation over surgery. On Breast Cancer Conservation Treatment, cosmetic results (BCCT core), 94% of patient cases were rated as good or excellent after thermal ablation vs 80% after surgery.

The study included 41 patients who underwent thermal ablation and subsequent surgery between March 2021 and May 2024. Treatment consisted of thermal ablative treatment of the primary tumor, followed by breast-conserving surgery, including sentinel node biopsy for 3 months afterwards.

Eligible patients were postmenopausal women who were 45 years or older with unilateral, unifocal, Bloom and Richardson grade 1 or 2, luminal type breast cancer, with tumors visible on ultrasound and a maximum size of 2 cm.

The cosmetic outcomes and patient satisfaction were evaluated through Breast-Q questionnaires, with 1 conducted directly before thermal ablation as baseline, prior to surgery, and 2 weeks following surgery; the BCTOS questionnaire, with 1 conducted directly before surgery and 1 conducted two weeks after surgery; the BCCT.core software program, with one taken before thermal ablation, before surgery, and 2 weeks after surgery; and patient satisfaction was measured after thermal ablation and after surgery via a questionnaire asking a patient if she would recommend the procedure to others and what she would choose if she was offered both thermal ablation and surgery as a treatment option.

The Radiology Paper

Cryoablation with ProSense® demonstrated the highest complete ablation rate with no complications and was associated with 0 total cases requiring oncoplastic surgery vs 2 cases in the radiofrequency ablation group and 2 cases in the microwave ablation group. Notably, radiofrequency ablation was halted early due to protocol-defined issues, and microwave ablation delivered moderate efficacy.

A pathologic complete response (pCR) was observed in 13 of 18 patients treated with microwave ablation, and 17 of 18 patients were treated with cryoablation.

A total of 50 patients were enrolled, and after exclusions due to additional lesions on MRI, tumor infiltration into areola, withdrawn consent, and unsuitability for MRI, a total of 41 patients underwent random assignment.

Eighteen patients were enrolled in the cryoablation group, and after an MRI stage where 1 patient missed target and 1 had early surgery, 17 underwent surgery 3 months post-ablation.

The primary end point of the trial was the rate of pCR. Secondary end points included outpatient feasibility, adverse effects, system usability, and pain scores.

References

1. Two new publications from the independent THERMAC trial featuring IceCure's ProSense® in breast cancer finds 95% of patients satisfied with thermal ablation; ProSense® cryoablation achieves highest complete ablation rate. News release. IceCure Medical Ltd. September 8, 2025. Accessed September 9, 2025. https://tinyurl.com/ycye9ype
2. Wooldrik S, van de Voort EF, Struik G, et al. Cosmetic outcome and patient satisfaction following percutaneous thermal ablation of early-stage breast cancer; results of an open label randomized phase 2 trial. Eur J Surg Oncol. 2025;51(10):110305. doi:10.1016/j.ejso.2025.110305
3. Wooldrik SM, van de Voort EMF, Struik GM, et al. Percutaneous thermal ablation for early-stage breast cancer: an open-label, randomized, phase II trial to select the preferred technique for evaluating thermal ablation as a surgical alternative. Radiology. 2025;316(2):e243386. doi:10.1148/radiol.243386