Initial Evaluation of the Safety of Nanoshell-Directed Photothermal Therapy in the Treatment of Prostate Disease

Joshua M. Stern, Viktor V. Kibanov Solomonov, Elena Sazykina, Jon A. Schwartz, Shayne C. Gad, Glenn P. Goodrich

Research output: Contribution to journalArticle

52 Citations (Scopus)

Abstract

To evaluate the clinical safety profile for the use of gold nanoshells in patients with human prostate cancer. This follows on the nonclinical safety assessment of the AuroShell particles reported previously. Twenty-two patients, with biopsy diagnosed prostate cancer, underwent nanoshell infusion and subsequent radical prostatectomy (RRP). Fifteen of these patients had prostates that were additionally irradiated by a single-fiber laser ablation in each prostate hemisphere prior to RRP. Patients in the study were assessed at 9 time points through 6 months postinfusion. Adverse events were recorded as reported by the patients and from clinical observation. Blood and urine samples were collected at each patient visit and subjected to chemical (16 tests), hematological (23 tests), immunological (3 tests, including total PSA), and urinalysis (8 tests) evaluation. Temperature of the anterior rectal wall at the level of the prostate was measured. The study, recorded 2 adverse events that were judged attributable to the nanoparticle infusion: (1) an allergic reaction resulting in itching, which resolved with intravenous antihistamines, and (2) in a separate patient, a transient burning sensation in the epigastrium. blood/hematology/urinalysis assays indicated no device-related changes. No change in temperature of the anterior rectal wall was recorded in any of the patients. The clinical safety profile of AuroShell particles is excellent, matching nonclinical findings. A recent consensus statement suggested that the published literature does not support a preference for any ablation technique over another.1 Now that clinical safety has been confirmed, treatment efficacy of the combined infusion plus laser ablation in prostate will be evaluated in future studies using imaging modalities directing the laser against identified prostate tumors.

Original languageEnglish (US)
Pages (from-to)38-46
Number of pages9
JournalInternational Journal of Toxicology
Volume35
Issue number1
DOIs
StatePublished - Jan 1 2016

Fingerprint

Nanoshells
Prostate
Safety
Laser ablation
Blood
Urinalysis
Biopsy
Histamine Antagonists
Laser Therapy
Therapeutics
Fiber lasers
Ablation
Gold
Tumors
Assays
Prostatic Neoplasms
Ablation Techniques
Nanoparticles
Imaging techniques
Temperature

Keywords

  • AuroShell
  • clinical safety
  • focal therapy
  • laser
  • nanoparticles
  • prostate cancer

ASJC Scopus subject areas

  • Toxicology

Cite this

Initial Evaluation of the Safety of Nanoshell-Directed Photothermal Therapy in the Treatment of Prostate Disease. / Stern, Joshua M.; Kibanov Solomonov, Viktor V.; Sazykina, Elena; Schwartz, Jon A.; Gad, Shayne C.; Goodrich, Glenn P.

In: International Journal of Toxicology, Vol. 35, No. 1, 01.01.2016, p. 38-46.

Research output: Contribution to journalArticle

Stern, Joshua M. ; Kibanov Solomonov, Viktor V. ; Sazykina, Elena ; Schwartz, Jon A. ; Gad, Shayne C. ; Goodrich, Glenn P. / Initial Evaluation of the Safety of Nanoshell-Directed Photothermal Therapy in the Treatment of Prostate Disease. In: International Journal of Toxicology. 2016 ; Vol. 35, No. 1. pp. 38-46.
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