AngioDynamics has announced the completion of enrolment and final treatment in its pivotal study of the NanoKnife system for ablation of prostate tissue in an intermediate-risk patient population (PRESERVE). The PRESERVE study was initiated by AngioDynamics. 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 enrolment 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.”
The co-principal investigators leading the study are Jonathan Coleman, urologic surgeon at Memorial Sloan Kettering Cancer Center (New York, USA), and Arvin George, urologic surgeon at University of Michigan (Ann Arbor, USA). The PRESERVE study will have its primary endpoint analysis at 12 months following treatment.
“As diagnostic tools develop to allow earlier identification and localisation 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 tumours (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,” said Coleman.
The NanoKnife system utilises irreversible electroporation (IRE) technology to destroy targeted tissue effectively, 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 extracellular matrix, facilitating post-ablation histological and functional tissue regeneration. To learn more and view risk information, visit NanoKnife.com.
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 facilities across the USA. Learn more about PRESERVE at angiodynamics.com/studies/preserve.