German firm MagForce and its MagForce USA division have obtained investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to study NanoTherm therapy as a focal ablation treatment in a clinical trial for intermediate risk prostate cancer.
The IDE approval allows the firm to perform a clinical trial at select medical centres in the country.
Developed for the local treatment of solid tumours, NanoTherm therapy is based on the direct introduction of magnetic nanoparticles into a tumour and subsequent heating in an alternating magnetic field.
According to MagForce, the treatment duration and temperatures achieved within the tumour result in irreparable damage or sensitisation of the cancer cells for further chemo or radiotherapy.
The firm also claims that the approach spares surrounding healthy tissue, as well as facilitates repeated treatments and multimodal therapy concepts as the nanoparticles remain at the treatment site.
Expected to start enrolment over the next few months, the focal thermal ablation registration single-arm IDE trial will include approximately 120 subjects.
The primary objective of the trial is to validate the capability of NanoTherm to focally ablate cancer lesions in patients who are suffering from advanced to intermediate risk prostate cancer stage and are under active surveillance.
The focal ablation of cancer lesions is expected to enable maintenance of such patients in active surveillance programmes, eliminating the need for definitive therapies such as surgery or whole gland radiation that are known to have side effects.