The NanoTherm therapy system for focal ablation of intermediate-risk prostate cancer continued to show a tolerable safety profile in a recent analysis.
Additional supportive data from stage 2a of a pivotal study of the NanoTherm therapy system for focal ablation of intermediate-risk prostate cancer confirm the initial findings showing that the treatment modality was safe and effective, according to MagForce AG who is responsible for developing the system.1
Results were taken from a 10-patient cohort showing that only minimal treatment-related adverse effects and a tolerable safety profile were reported.
“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, Inc, said 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.”
The favorable safety profile was consistent with that reported in the Stage 1 portion of the study.2 Adverse effects of therapy were similar to those commonly associated with biopsies.
The essential function of NanoTherm involves the introduction of magnetic nanoparticles “either directly into the tumor or into the resection cavity wall,” which are then heated by an alternating magnetic field leading to cancer cell death.
Efficacy results appear promising in this patient population, with well-defined ablation and tumor cell death noted in the area of nanoparticle deposition. Minimal tissue damage outside of 2 to 4mm from the deposit edge were also reported.
In part 2a, clinical target volume accuracy was improved at 92.4% (standard deviation [SD], 5.4%) versus 34.9% (SD, 16.9%) in Stage 1, resulting in more nanoparticle mass in the targeted area.
The stage 2b portion of the single-arm registration trial will launch at 3 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 aim of the therapy is to spare patients from receiving definitive therapy, such as surgery or whole gland radiation, which are associated with high toxicity rates and implication of surrounding healthy tissue. Upon FDA approval, the procedure will allow for treatment to be completed in a single day.
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. News release. MagForce AB. April 26, 2021. Accessed May 4, 2021. https://bit.ly/3umAwjw
2. 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. News release. MagForce AB. February 8, 2021. Accessed May 4, 2021. https://bit.ly/2SrdtWD