Category: MIS Image Guided/ Focal-cryo/RFA/HIFU: Prostate

MP23-13 - MR/US Fusion Guided Ultra-Focal Gold Silica Nanoshell Directed Laser Ablation of Prostate Tumors: Side effects and functional outcomes from 12 patients. Phase I/II Clinical Trial

Sat, Sep 22
2:00 PM - 4:00 PM

Introduction & Objective :

Multiparametric MRI (mpMRI) has made it possible to visualize, biopsy, and treat specific lesions in the prostate using focal therapy (FT). The rationale behind FT is to achieve cancer control while minimizing side effects associated with surgery and/or radiation. Gold silica nanoshell (GSN) directed laser ablation of prostate tumors is a novel FT modality, currently under investigation


Methods : To be eligible for this trial, patients must have a biopsy confirmed, Gleason ≤ 7 MR visible prostate cancer (PCa) lesion. In addition, PSA must be under 15 or PSA density must be under 0.15, and clinical stage cannot be higher than T2a. On day 1, patients received a 7.5mL/Kg GSN infusion which subsequently accumulated in PCa lesions due defective cancerous endothelium. On day 2, laser ablation of PCa was performed using an electromagnetically tracked MR/US fusion guided transperineal approach. The near-infrared laser wavelength used is converted to heat by the GSN (residing in PCa), while healthy tissue (primarily composed of water and hemoglobin) is affected mildly. This results in focal ablation of PCa, while sparing the rest of the prostate. Side effects within the 30-day postoperative period and change in IPSS and SHIM scores at 3 months follow-up were recorded


Results : We report the results from the first twelve patients enrolled in our institution. The median PSA was 6.15 (range: 0.82-11.96), the median size of the lesions treated was 0.475 (range: 0.06-1.56), and the median duration of the procedure was 224 min (range: 115-345). One patient experienced self-resolving epigastric-subcostal pain during GNS infusion, and did not complete treatment. The remaining 11 patients completed treatment in an outpatient setting. Self-resolving CTCAE grade I/II hematuria was universally experienced by all 11 patients. 4 out of 11 failed the trial of void and a Foley catheter was left in place for 1-2 days (CTCAE grade II). The median IPSS score dropped from 12 (range: 3-19) at baseline to 8 (range:2-10) at 3 months f/u. In sexually active patients, the median SHIM score dropped from 21 (range: 8-25) at baseline to 17 (range: 7-24) at 3 months f/u


Conclusions : GNS laser ablation is a novel treatment modality for localized PCa and demonstrates a favorable side effect profile and improved functional outcomes.  Although these early results are favorable, long term follow-up is needed before drawing any meaningful conclusions

Harry Anastos

The Icahn School of Medicine at Mount Sinai, Department of Urology
New York, New York

Saikrishnaraya Doppalapudi

Newark, New Jersey

Jared Winoker

Resident Physician
The Icahn School of Medicine at Mount Sinai, Department of Urology
New York, New York

Pratik Shukla

The Icahn School of Medicine at Mount Sinai, Department of Radiology
New York, New York

Shivaram Cumarasamy

Icahn School of Medicine at Mount Sinai
New York, New York

John Sfakianos

Assistant Professor of Urology
Icahn School of Medicine at Mount Sinai
New York, New York

Michael R. Carrick

The Icahn School of Medicine at Mount Sinai, Department of Radiology
New York, New York

Cynthia J. Knauer

The Icahn School of Medicine at Mount Sinai, Department of Urology
New York, New York

Bachir Taouli

Professor of Radiology
Icahn School of Medicine at Mount Sinai
New York, New York

Sara C. Lewis

Assistant Professor of Radiology
Icahn School of Medicine at Mount Sinai
New York, New York

Art Rastinehad

The Icahn School of Medicine at Mount Sinai, Department of Urology
New York, New York