Pivotal study to evaluate AuroLase therapy for prostate tissue ablation

Nanospectra Biosciences, Inc. recently announced the start of a pivotal study to determine the efficacy of using magnetic resonance imaging/ultrasound fusion imaging technology to direct focal ablation of prostate tissue using nanoparticle-directed laser ablation.

The initial two patient procedures in the pivotal trial have been completed at the University of Michigan, Ann Arbor, which also participated in the pilot study. The AuroLase pivotal study follows the successful first-in-human pilot study that enrolled 46 subjects at three U.S. sites.

Clinical and functional outcomes of a subset of subjects at the lead site in the feasibility study were published in Proceedings of the National Academy of Sciences (2019; 116:18590-6). Thirteen of the first 15 prostate cancer patients treated in the clinical trial of the nanoparticle-based focal therapy showed no detectable signs of cancer upon biopsy in the target ablation zone a year after treatment. The final results of the feasibility study are expected later this year.

The pivotal study is an open-label, multicenter, single-treatment study of AuroLase Therapy for the focal ablation of prostate tissue via nanoparticle-directed near infrared irradiation and approved by the FDA under the original Investigational Device Exemption. Up to 60 patients will be enrolled at up to eight clinical trial sites throughout the U.S.

Efficacy of focal ablation of prostate tissue will be assessed by MRI/ultrasound-guided target biopsy 6 months after laser treatment and at 1 year via targeted biopsy and standard systematic biopsy.

Ardeshir Rastinehad, DO, of Lenox Hill Urology and Northwell Health System, New York and the initial study’s lead principal investigator, presented preliminary feasibility study data at the International Symposium on Focal Therapy and Imaging in Prostate and Kidney Cancer in Washington.