The NanoTherm therapy system continues to show promise as a novel technique for the focal ablation of intermediate-risk prostate cancer, according to updated data from a pivotal trial announced by MagForce AG, the developer of the therapy.1
In the 2-stage pivotal trial of NanoTherm, a streamlined procedure that enables treatment completion in 1 day is being used in stage 2, as compared with a longer procedure used in stage 1.
MagForce reported in a press release today that multiple safety analyses have now found no new safety signals with the 1-day process used in the 10 patients enrolled in the stage 2a cohort, as compared with the patients in the stage 1 cohort. The company specifically noted that treatment-related side effects observed in stage 2a were minimal and similar to those reported in stage 1.
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
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.
Regarding the effectiveness of the treatment, initial signs from stage 2a have been positive. “Ablation-analysis…showed well-defined ablation and cell death in the region of the nanoparticle deposit, with minimum tissue damage outside 2 to 4 mm from the deposit edge,” MagForce reported in the press release.
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 100 patients with prostate cancer who are under active surveillance and whose disease has progressed to intermediate risk.
“The already very encouraging initial findings are supported by the further analysis of the Stage 2a data. The study so far indicates that the optimized instillation procedure is minimally invasive and highly accurate making our approach precisely targeted and able to fight the tumor without damaging the healthy surrounding tissue,” Ben Lipps, CEO of MagForce AG and MagForce USA, stated in a press release. “These data are promising, and I am excited by what they could mean for men living with this disease. The benefits for this group of patients are tremendous. Therefore, we remain committed to bringing this therapeutic option to patients as expeditiously as possible.”
1. MagForce Announces Additional Supportive Data from Stage 2a of its Pivotal U.S. Single-Arm Study for the Focal Ablation of Intermediate Risk Prostate Cancer with the NanoTherm Therapy System. Published online April 26, 2021. Accessed April 26, 2021. https://bit.ly/3vluYFO.
2. MagForce. The NanoTherm® therapy. Accessed February 8, 2021. https://bit.ly/3oXn1mB.