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Proc Natl Acad Sci U S A. 2019 Sep 10;116(37):18590-18596. doi: 10.1073/pnas.1906929116. Epub 2019 Aug 26.

Gold nanoshell-localized photothermal ablation of prostate tumors in a clinical pilot device study.

Author information

1
Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY 10029; art.rastinehad@mountsinai.org halas@rice.edu.
2
Department of Radiology, Icahn School of Medicine at Mount Sinai, New York, NY 10029.
3
Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY 10029.
4
Clinical Research, Nanospectra Biosciences, Inc., Houston, TX 77054.
5
Department of Urology, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX 77030.
6
Department of Urology, Michigan Medicine University of Michigan, Ann Arbor, MI 48109.
7
Department of Biomedical Engineering, Duke University, Durham, NC 27708.
8
Laboratory for Nanophotonics, Rice University, Houston, TX 77005 art.rastinehad@mountsinai.org halas@rice.edu.

Abstract

Biocompatible gold nanoparticles designed to absorb light at wavelengths of high tissue transparency have been of particular interest for biomedical applications. The ability of such nanoparticles to convert absorbed near-infrared light to heat and induce highly localized hyperthermia has been shown to be highly effective for photothermal cancer therapy, resulting in cell death and tumor remission in a multitude of preclinical animal models. Here we report the initial results of a clinical trial in which laser-excited gold-silica nanoshells (GSNs) were used in combination with magnetic resonance-ultrasound fusion imaging to focally ablate low-intermediate-grade tumors within the prostate. The overall goal is to provide highly localized regional control of prostate cancer that also results in greatly reduced patient morbidity and improved functional outcomes. This pilot device study reports feasibility and safety data from 16 cases of patients diagnosed with low- or intermediate-risk localized prostate cancer. After GSN infusion and high-precision laser ablation, patients underwent multiparametric MRI of the prostate at 48 to 72 h, followed by postprocedure mpMRI/ultrasound targeted fusion biopsies at 3 and 12 mo, as well as a standard 12-core systematic biopsy at 12 mo. GSN-mediated focal laser ablation was successfully achieved in 94% (15/16) of patients, with no significant difference in International Prostate Symptom Score or Sexual Health Inventory for Men observed after treatment. This treatment protocol appears to be feasible and safe in men with low- or intermediate-risk localized prostate cancer without serious complications or deleterious changes in genitourinary function.

KEYWORDS:

MRI-ultrasound fusion; focal therapy; gold nanoshell; photothermal therapy; prostate cancer

Conflict of interest statement

Conflict of interest statement: A.R.R. is the national principal investigator for the multiinstitutional trial of GSN-directed ablation, funded by Nanospectra Biosciences. He is also a consultant for Nanospectra Biosciences. J.L.W. and N.J.H. cofounded Nanospectra Biosciences in 2001 to transfer the photothermal therapeutics process from their labs into the clinic. They both have a small equity stake in this company but are not involved in any way with the company’s business or strategic decisions.

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