Study Begins to Assess Long-Term Impact of NanoKnife Treatment

AngioDynamics Inc. is partnering with University College London Hospital (UCLH) on an international study to assess the long-term impact of NanoKnife System treatment in men with unifocal intermediate-risk prostate cancer.

Approximately 40% of all diagnosed prostate cancer cases are classified as intermediate risk.¹ In the first year after surgery, 36% of men report urinary leakage, and 95% are affected by erectile dysfunction (70% described as moderate/severe).²

“The international registry will allow us to track patients’ outcomes over time and allow us to quality control the dissemination of this novel technology across the world,” said Professor Mark Emberton, Interventional Oncology, Division of Surgery and Interventional Science at UCLH. “This will enable us to learn from every patient treated and, as a result, continue to refine this treatment that allows men to have their prostate cancer treated and maintain their quality of life.”

The NanoKnife System delivers an alternative to conventional radical surgery or radiotherapy, each of which often results in significant dysfunction in urinary continence and erectile potency. With its non-thermal approach, the NanoKnife system is engineered to preserve vital structures inside and outside the prostate, offering patients an effective treatment of tumors, low complication rates, and minimal impact on quality of life.³

Last year, the U.K.’s National Institute for Health and Care Excellence (NICE) upgraded the NanoKnife System’s use from “Research Only” to “Special Arrangements,” allowing hospitals to start new services while collecting more data⁴ and signaling its growing acceptance in national urology guidelines.

AngioDynamics is conducting the international multi-center prospective registry study in partnership with UCLH, the United Kingdom’s largest center for robotic prostate surgery and a provider of focal therapy, radiotherapy, robotic surgery, and active surveillance treatment options for prostate cancer patients. Additionally, UCLH was the first facility in the National Health Service to use the NanoKnife System to treat prostate cancer,⁵ and provide standardized patient selection, treatment, and long-term follow-up.

“Focal therapy has developed over the past 10 years to identify patients with the most to gain from treatment effectively. We can now test a large cohort of patients to show benefit without adding long-term risk,” said Laura Piccinini, AngioDynamics senior vice president and general manager of Endovascular Therapies and International. “We are proud of the partnership with UCLH in conducting this important study. This extensive prospective study will help support broader adoption, expanded treatment pathways, and increased patient access to improved treatment modalities for men in the U.K. with prostate cancer and help establish treatment with this technology as a standard of care. This collaboration demonstrates our steadfast commitment to supporting the physician community and their patients with innovative and effective products.”

The study will enroll a minimum of 500 patients worldwide to confirm the multiple single-center published papers indicating that the NanoKnife System is safe and effective in treating targeted tumors,³ and preventing or delaying the need for radical intervention in preserving patients’ quality of life.

Complementing the ongoing Randomized Controlled Trial studies evaluating NanoKnife versus radical treatment,^6,7 this investigator-initiated trial will closely monitor patients post-treatment, measuring critical quality of life metrics and tracking any necessary follow-up interventions. In addition to quality of life, the study will assess overall and prostate-specific mortality rates.

The NanoKnife System uses irreversible electroporation (IRE) technology to effectively destroy targeted cells without the use of thermal energy by delivering high-voltage pulses, creating permanent nanopores within the cell membrane. This stimulus induces an apoptotic-like cellular death in the targeted tissue, resulting in a complete ablation of the targeted tissue.

The NanoKnife System when used for the treatment of prostate cancer is an investigational device in the United States. The NanoKnife System has not received U.S. Food and Drug Administration clearance for the therapy or treatment of any specific disease or condition. In the European Union, the NanoKnife System is indicated for the ablation of prostate tissue in patients with intermediate risk prostate cancer. The use of this device in other organs for other disease states has not been fully evaluated.

AngioDynamics is a medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life. The company’s technologies and devices are chosen by physicians to treat unmet patient needs.

References
¹ https://www.npca.org.uk/wp-content/uploads/2021/01/NPCA-Annual-Report-2020_Final_140121.pdf (p.25)
² https://bjui-journals.onlinelibrary.wiley.com/doi/10.1111/bju.15739
³ https://doi.org/10.1016/j.urology.2023.01.024
⁴ https://www.nice.org.uk/guidance/ipg768
⁵ https://www.uclh.nhs.uk/news/uclh-first-nhs-use-nanoknife-prostate-cancer
⁶ https://fundingawards.nihr.ac.uk/award/17/150/01
⁷ https://clinicaltrials.gov/study/NCT05513443