This study, initiated by AngioDynamics, Inc. in partnership with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), will evaluate the use of the NanoKnife System as a focal therapy option for prostate cancer patients. It will assess the safety and effectiveness of the device when used to ablate prostate tissue in intermediate-risk prostate cancer patients.

The overall goal of this study is to evaluate the safety and effectiveness of the NanoKnife System to ablate prostate tissue when used in an intermediate-risk patient population.

Co-principal Investigators

The co-principal investigators for this study are:

Dr. Jonathan Coleman from Memorial Sloan Kettering Cancer Center

Dr. Jonathan-Coleman

Dr. Arvin George from the University of Michigan

Dr. Arvin George

About NanoKnife System and IRE Technology

Irreversible Electroporation, also known as IRE, is a technique utilizing electrical pulses to create permanent nanopores in the cell membrane to disrupt cellular homeostasis. This disruption initiates an apoptotic-like effect which leads to permanent cell death.1

The IRE technology used in this study is known as the NanoKnife System. The NanoKnife System is an ablative device that uses non-thermal energy to deliver a series of high voltage direct current electrical pulses between electrodes placed within a target area of tissue. The NanoKnife System can use anywhere from 2-6 probes per procedure. The NanoKnife System has been cleared by the FDA for the surgical ablation of soft tissue. Currently, it has not received clearance for the therapy or treatment of any specific disease or condition.

Cited References

1 Lee EW, Thai S, Kee ST. Irreversible electroporation: a novel image-guided cancer therapy. Gut Liver. (2010);4(SUPPL. 1):99–104. doi: 10.5009/gnl.2010.4.S1.S99.

Important Risk Information

AngioDynamics, the AngioDynamics logo, NanoKnife and the NanoKnife logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. © 2022 AngioDynamics, Inc. GL/ON/WP/1036 REV 02 02/2022. All other trademarks are property of their respective owners.

The NanoKnife System when used for the treatment of prostate cancer is an investigational device. Limited by United States law to investigational use.