Enrollment Completed in PRESERVE Clinical Trial

AngioDynamics Inc. has completed enrollment and final treatment in its pivotal study of the NanoKnife System for Ablation of Prostate Tissue in an Intermediate-Risk Patient Population (PRESERVE). AngioDynamics initiated the trial in partnership with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC).
 
“The PRESERVE study demonstrates AngioDynamics’ commitment to innovating care delivery,” said Juan Carlos Serna, AngioDynamics senior vice president of Clinical and Scientific Affairs. “As we mark the completion of enrollment and final treatment in the study, we take another important step towards demonstrating the NanoKnife System’s ability to expand treatment options for patients with intermediate-risk prostate cancer and advance our mission to improve patient quality of life. We appreciate the support provided by our PRESERVE study sites and the partnership with the SUO-CTC team in this important effort.”
 
Co-principal investigators leading the study are Jonathan Coleman, M.D., a urologic surgeon at Memorial Sloan Kettering Cancer Center, and Arvin George, M.D., a urologic surgeon at the University of Michigan. The PRESERVE study will have its primary endpoint analysis at 12 months following treatment.
 
“As diagnostic tools develop to allow earlier identification and localization of clinically significant forms of prostate cancer, there is a matching need to establish effective forms of treatment that target the disease and preserve patients’ quality of life. Evidence is growing to support the use of partial gland ablation for prostate cancer as a reasonable alternative treatment strategy in carefully selected patients. The PRESERVE study, studying the efficacy of irreversible electroporation (IRE) with the NanoKnife System from AngioDynamics in men with intermediate-risk tumors (Gleason Grade 3+4 and 4+3), will help to address further the validity of this therapeutic approach using a treatment, which is well tolerated and easy to apply in prostate tissue,” Coleman stated.
 
The American Cancer Society expects 288,300 new cases of prostate cancer to be diagnosed this year and about 34,700 deaths to be attributed to the disease in the United States. An estimated one of every eight men will be diagnosed with prostate cancer during their lifetime, and prostate cancer is more likely to develop in older and non-Hispanic Black men. It is American men’s second leading cause of death.¹
 
The NanoKnife System utilizes Irreversible Electroporation (IRE) technology to effectively destroy targeted tissue, delivering precise treatment margins while preserving vital structures by retaining the structural integrity of the targeted tissue. The delivery of non-thermal energy allows for the preservation of the extra-cellular matrix, facilitating post-ablation histological and functional tissue regeneration. 
 
The PRESERVE study’s primary objectives are determining the NanoKnife System’s ablation effectiveness by measuring the negative in-field biopsy rate at 12 months and determining the NanoKnife System’s procedural and post-procedural safety profile by evaluating adverse event incidence, type and severity through 12 months. The study enrolled and treated 121 patients in 17 U.S. facilities. 
  
The NanoKnife System, when used for the treatment of prostate cancer, is an investigational device limited by U.S. law to investigational use. In the United States, the NanoKnife System has received a 510(k) clearance by the U.S. Food and Drug Administration for use in the surgical ablation of soft tissue and is similarly approved for commercialization in Canada, the European Union and Australia. The NanoKnife System has not been cleared for the treatment or therapy of a specific disease or condition.

AngioDynamics is a medical technology company focused on restoring healthy blood flow in the body’s vascular system and expanding cancer treatment options. The company’s technologies and devices are chosen by physicians in fast-growing healthcare markets to treat unmet patient needs. 
 
Reference
¹ Key Statistics for Prostate Cancer | Cancer.org. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html. Published 2023. Accessed July 27, 2023.