Patient enrollment has been completed for a pivotal trial of the novelnanoparticle-based focal ablation therapy AuroLase for patients with prostate cancer, according to Nanospectra Biosciences, the developer of the treatment.1
AuroLase involves the intravenous delivery of nanoshells which flow through the bloodstream and amass in the prostate tumor. The clinician then uses targeted MRI Ultrasound fusion technology to identify the lesion and position an optical fiber probe. The prostate tissue is then ablated via the emission of near-infrared energy from an FDA-cleared laser. The precision of the technology spares surrounding healthy tissue from harm.
The pivotal open-label, single-treatment trial of AuroLase has now enrolled 60 patients at 9 clinical locations in the United States. This study was preceded by a positive first-in-human feasibility study that included 46 patients who were treated at 3 US clinical sites.
The efficacy of AuroLase is being evaluated at 6 months using MRI/Ultrasound guided target biopsy. At 1-year following focal ablation, investigators will assess the procedure using both targeted biopsy and standard systematic biopsy. As per standard of care, follow-up will continue after the 1-year visit; however, the results of these visits are beyond the scope of the trial.
“I am pleased to have led such a groundbreaking trial, which is poised to have an indelible impact on patients’ lives and the continued evolution of standard of care for localized prostate cancer,” Ardeshir Rastinehad, DO, vice chair of Lenox Hill Urology and System Director of Prostate Cancer/Northwell Health System and the study’s national principal investigator, stated in the news release. “I am strongly encouraged by the results of the feasibility study and the data that we have seen thus far in the extension study as it relates to oncologic control, maintenance of patient functional outcomes, and an absence of adverse side effects.”
Also commenting in the news release, Steven E. Canfield, MD, professor and chief, Division of Urology, Edward J McGuire, MD, Distinguished Chair, McGovern Medical School, UT Health Houston, stated, “The side effects of prostate cancer treatments are well known and may lead some men to delay or not seek screenings or treatment. To date, the AuroLase clinical trial has been very successful and I see a future pathway where this treatment will be a commonly used and accepted procedure for men with localized prostate cancer.”
Nanospectra anticipates that the initial 6-month study results will be available in mid-2022, with the complete results likely to be available by the end of 2022. The company also expects to file for FDA regulatory clearance by the end of next year, with the submitted data package to include both the feasibility and pivotal study datasets.
“I would like to thank the investigators and their clinical research teams for their remarkable work on this study, especially given challenges navigating the Covid pandemic,” David Jorden, CEO of Nanospectra, stated in the news release. “Completion of trial enrollment establishes the timeline of final data availability and submission for FDA marketing clearance of our AuroLase Therapy for prostate tissue ablation.”
1. Nanospectra Biosciences Announces Enrollment Completion of Pivotal Study of AuroLase Therapy for Ablation of Prostate Tissue. Posted online November 2, 2021. Accessed November 9, 2021. https://yhoo.it/3qjKtPv.