A streamline procedure allows treatment with the NanoTherm therapy system for focal ablation to be completed within 1 day.
Patient treatment has been completed in the initial part of stage 2 of a pivotal trial of the NanoTherm therapy system for the focal ablation of intermediate-risk prostate cancer, according to MagForce AG, the developer of the therapy.1
Initial findings for this stage 2a part of the trial showed that in 10 patients, there were no new safety signals observed compared with stage 1 of the trial. Treatment-related side effects observed in stage 2 were minimal and similar to those reported in stage 1. Efficacy results from stage 1 had previously shown that in the area of the nanoparticle deposit, there was well-defined ablation and cell death.
Also of note, a streamlined procedure that enables treatment completion in 1 day was used in stage 2a, as compared with a longer procedure used in stage 1.
“Although expected, we are very happy that the findings indicate the streamlined study procedure will benefit patients by completing the entire treatment within 1 day, thus minimizing the burden of repeated clinical visits. We experience the importance of this especially in times of the current pandemic with its heightened anti-infection protocols, and I am even more grateful for all patients participating in our clinical trial despite the increased effort due to testing and quarantine this means for every single one of them,” Ben Lipps, CEO of MagForce AG and MagForce USA, stated in a press release.
“Now, we prepare the start of the final stage 2b of our focal ablation study, which is expected in early Q2. Immediately upon FDA approval we will start commercialization, which is still expected for the second half of 2021, assuming that the COVID-19 situation eases in spring,” added Lipps.
The final part of this pivotal, single-arm focal ablation registration trial, stage 2b, is being launched at 3 of the company’s focal treatment centers in Texas, Washington, and Florida. The overall recruitment goal of the trial is 120 patients with prostate cancer who are under active surveillance and whose disease has progressed to intermediate risk.
The researchers hope that the NanoTherm therapy system can successfully ablate the cancer lesions to the level at which the patient can delay or avoid definitive therapy and remain on active surveillance. This could potentially offer patients an option with limited side effects, whereas definitive therapies, such as surgery and whole gland radiation, are historically linked to more extensive toxicity.
According to MagForce, the basic mechanism of NanoTherm involves the introduction of magnetic nanoparticles “either directly into the tumor or into the resection cavity wall. These particles are subsequently heated by an alternating magnetic field, thus destroying the cancer cells.”2
1. MagForce AG: MagForce USA, Inc. Announces Completion of Patient Treatment in Stage 2a of Pivotal U.S. Single-Arm Study for the Focal Ablation of Intermediate Risk Prostate Cancer with the NanoTherm Therapy System. Posted online February 8, 2021. Accessed February 8, 2021. https://bit.ly/36SAo1a.
2. MagForce. The NanoTherm® therapy. Accessed February 8, 2021. https://bit.ly/3oXn1mB.