Nanospectra Biosciences, a US-based medical device company, has announced the clinical trial results of its AuroLase Therapy used for focal ablation of prostate tissue.
According to the company, prostate cancer is the most common cancer type, and the overtreatment of prostate cancer with whole gland treatments emphasises a need for better focal therapies with fewer complications.
Nanospectra CEO David Jorden said: “As the first ultra-focal therapy for prostate cancer, AuroLase has the potential to maximize treatment efficacy while minimizing side effects associated with surgery, radiation, and traditional focal therapies.
“We are encouraged by the clinical success of our feasibility study to date and look forward to the initiation, potentially next month, of the pivotal study with an expected cumulative treatment population of 100 subjects.”
Nanospectra is focused on novel use of nanomedicine for selective thermal tissue ablation
Nanospectra Biosciences has designed the multi-site study using laser-excited gold-silica nanoparticles (GSN) in combination with multiparametic MRI (mpMRI) fusion imaging, to focally ablate low to intermediate grade tumours within the prostate.
GSN are designed to offer a highly localised light-based strategy for the treatment of prostate cancer with substantially reduced risks of harmful treatment-related side effects, by absorbing near-infrared light at wavelengths of high tissue transparency and convert the light energy to heat.
The pilot device study enrolled 16 subjects diagnosed with localised, low to intermediate risk prostate cancer and reported effectiveness and safety data.
Following GSN infusion and targeted laser ablation, patients underwent MRI of the prostate at 48 – 72 hours, followed by post-procedure mpMRI/US targeted fusion biopsies at three and 12 months, as well as a standard 12-core systematic biopsy at 12 months.
GSN-mediated focal laser ablation was achieved in 94% (15 of 16) patients in the study.
The initial study results were published in the Proceedings of the National Academy of Sciences (PNAS) in a paper titled ‘Gold Nanoshell-Localized Photothermal Ablation of Prostate Tumors in a Clinical Pilot Device Study’.
Principal investigator of the study Ardeshir R Rastinehad said: “This first in human pilot device study demonstrates that GSN-directed laser excitation and ablation is a safe and technically feasible procedure for the targeted thermal destruction of prostate tumors and I am very excited to be part of this new frontier in nanomedicine.
“The early results are very encouraging and with feasibility study enrollment now complete we anticipate publishing results at the initial three month endpoint for mpMRI targeted fusion biopsies for the entire 45 subject population early next year.”
