Focal therapy aims to provide a durable oncological 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.
A prospective open-label, single-arm multicenter study of men with localized PCa in the Gleason Grade Group (GGG) 1 to 3 was conducted. Men received a single infusion of gold nanoparticles (AuroShells), followed by MR/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.
Forty-six men were enrolled in the study, and 44 men with 45 lesions completed nanoparticles infusion and laser treatment. The mean PSA level at baseline was 9.5 ng/mL, which decreased 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 GGG, maximum-lesion-diameter (MLD) on MRI, prostate volume, and PI-RADS scoring, the MLD was significantly associated with the odds of treatment failure at 12-months (P = .046).
Nanoparticle-directed focal laser ablation of neoplastic prostate tissue resulted in 73% patients with successful treatment at 12-months post-treatment, confirmed by negative MR/US fusion biopsy of the treated lesion and a systematic biopsy.
The Journal of urology. 2024 Sep 03 [Epub ahead of print]
Steven E Canfield, Arvin K George, Joshua S Jue, Sara C Lewis, Matthew S Davenport, Varaha S Tammisetti, Mahir Maruf, Leonardo D Borregalaes, Yara Kadria-Vili, Jon A Schwartz, Jennifer West, Naomi J Halas, Ardeshir R Rastinehad
Division of Urology, Department of Surgery, UTHealth, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, Texas., Department of Urology, Michigan Medicine, University of Michigan, Ann Arbor, Michigan., Smith Institute for Urology at Lenox Hill Hospital, Northwell Health, Zucker School of Medicine at Hofstra/Northwell, New York, New York., Department of Radiology, Mount Sinai, Icahn School of Medicine at Mount Sinai, New York, New York., Department of Radiology, Michigan Medicine, University of Michigan, Ann Arbor, Michigan., Department of Diagnostic and Interventional Imaging, UTHealth, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, Texas., Clinical Research, Nanospectra Biosciences, Inc., Houston, Texas., School of Engineering and Applied Science, University of Virginia, Charlottesville, Virginia., Smalley-Curl Institute and the Department of Electrical and Computer Engineering, Rice University, Houston, Texas.