Nanoparticle Therapy
For patients with a "low-risk" and "intermediate-risk" localized prostate cancer, there is active research into developing new methods of treatment that may be simpler and may have reduced risk of long-term side effects compared to standard treatments. Many of these treatments are examining the possibility of 'tumor ablation' in which, instead of treating the entire gland for a tumor that may occupy only a small fraction of the prostate, treatment is delivered to eliminate only the cancer, preserving the prostate gland. MagForce USA is developing a new approach to treating localized prostate cancer using its nanotechnology-based thermal ablation system. This system consists primarily of two components -- the NanoTherm™ Liquid and the NanoActivator® Device. Both components are investigational, meaning they have not been reviewed by the FDA for safety or effectiveness, and are undergoing clinical testing (The MagForce® Prostate Cancer Study) to evaluate these outcomes.
The NanoTherm™ Liquid
The centerpiece of the MagForce thermal ablative therapy is the NanoTherm™ Liquid. It contains billions of tiny particles (nanoparticles) of iron oxide that are 500 times smaller than a red blood cell. A key property of the nanoparticles is that they act like tiny bar magnets when they are exposed to an external magnetic field. If the nanoparticles are exposed to a magnetic field that is rapidly changing, they flip back-and-forth intensely, and heat is generated. Another key property of the nanoparticles is the special silica coating that helps the nanoparticles clump together and remain inside the prostate cancer lesion after being injected. It is this property of the NanoTherm™ particles, to clump together after injection and, with magnetic activation, to heat up and potentially kill cancer cells, that is being testing in this clinical trial.
The NanoActivator® Device
After the NanoTherm™ nanoparticles are injected into a prostate cancer lesion, they need to be "activated" in order to generate the heat that is intended to kill the cancer cells. This is done using a specially designed machine built by MagForce called the NanoActivator® device. The NanoActivator® device generates a rapidly changing (or oscillating) magnetic field that causes the iron oxide nanoparticles to intensely vibrate and create heat in the tissues surrounding it. This device is similar to an MRI machine, in that it uses magnetic fields, but instead of imaging the cancer, it is designed to kill the cancer by heating the cancer cells to a level where they die. When not in an activation device, the magnetic particles remain inert within the prostate.
The NanoTherm™ Therapy
The first step in the process is to examine the prostate cancer using a special type of MRI called a multi-parameteric MRI -- or mpMRI for short. The imaging data from the mpMRI is downloaded into a targeting software system that shows the prostate cancer on ultrasound imaging. This then allows targeting of the cancer and instillation of the NanoTherm™ liquid. Once it is confirmed by CT scan that the NanoTherm™ Liquid has been instilled into the proper location, the patient then lies in the NanoActivator® device. The magnetic field strength is slowly increased over a period of 15 minutes and, once temperature inside the target area reaches 55 degrees Celsius, the treatment session is begun. After 60 minutes of activation, the magnetic field is turned off and the temperatures within the prostate return to normal and the treatment is complete.