Faculty, Staff and Student Publications

Language

English

Publication Date

12-1-2024

Journal

Journal of Urology

DOI

10.1097/JU.0000000000004222

PMID

39226591

PMCID

PMC12721635

PubMedCentral® Posted Date

9-3-2024

PubMedCentral® Full Text Version

Post-print

Abstract

Purpose: Focal therapy aims to provide a durable oncologic treatment option for men with prostate cancer (PCa), while preserving their quality of life. Most focal therapy modalities rely on the direct tissue effect, resulting in a possible nontargeted approach to ablation. Here, we report the results of the first human feasibility trial utilizing nanoparticle-directed focal photothermal ablation for PCa.

Materials and methods: A prospective, open-label, single-arm, multicenter study of men with localized PCa in Gleason Grade Group 1 to 3 was conducted. Men received a single infusion of gold nanoparticles (AuroShells), followed by magnetic resonance (MR)/ultrasound (US) fusion-guided laser excitation of the target tissue to induce photothermal ablation. MRI was used to assess the effectiveness of prostate tissue ablation at 48 to 96 hours, 3 months, and 12 months post treatment. At 3 months, a targeted fusion biopsy of the lesion(s) was conducted. At 12 months, a targeted fusion biopsy and standard templated biopsy were performed. Treatment success was determined based on a negative MR/US fusion biopsy outcome within the treated area.

Results: Forty-six men were enrolled in the study, and 44 men with 45 lesions completed nanoparticle infusion and laser treatment. Baseline mean PSA levels were 9.5 ng/mL, with a statistically significant decrease of 5.9 ng/mL at 3 months and 4.7 ng/mL at 12 months (P < .0001). The oncologic success rates at 3 and 12 months resulted in 29 (66%) and 32 (73%) of 44 patients, respectively, being successfully treated, confirmed with negative MR/US fusion biopsies within the ablation zone. Among Gleason Grade Group, maximum lesion diameter on MRI, prostate volume, and Prostate Imaging Reporting and Data System scoring, the maximum lesion diameter was significantly associated with the odds of treatment failure at 12 months (P = .046).

Conclusions: Nanoparticle-directed focal laser ablation of neoplastic prostate tissue resulted in 73% of patients with successful treatment at 12 months post treatment, confirmed by negative MR/US fusion biopsy of the treated lesion and a systematic biopsy.

Keywords

Humans, Male, Prostatic Neoplasms, Prospective Studies, Aged, Middle Aged, Feasibility Studies, Gold, Magnetic Resonance Imaging, Ultrasonography, Interventional, Laser Therapy, Metal Nanoparticles, Magnetic Resonance Imaging, Interventional, Treatment Outcome, Neoplasm Grading, Image-Guided Biopsy, Multimodal Imaging, Prostate, prostate cancer, nanoparticles, focal therapy, prostate, ablation, laser, MR/US fusion

Comments

Trial registration: ClinicalTrials.gov NCT02680535.

Published Open-Access

yes

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