Validation of Artificial Intelligence-enhanced Stimulated Raman Histopathology for Intraoperative Margin Assessment During Robot-assisted Radical Prostatectomy: Preliminary Results from the ROBOSPEC Study

Abstract

Background and objective: Stimulated Raman histology (SRH) offers promising near-real-time tissue visualization for intraoperative pathology assessment. We present preliminary results from the ROBOSPEC study, with a focus on the accuracy of results obtained via an integrated artificial intelligence (AI) tool. Methods: ROBOSPEC is a prospective, single-arm pilot study involving patients with prostate cancer undergoing robot-assisted radical prostatectomy (RARP). Probes from the RP specimens from the first 18 patients with intermediate-risk or high-risk prostate cancer were collected bilaterally from the dorsolateral sides of the prostate and examined with frozen section with hematoxylin and eosin staining (cryo-HE), SRH imaging (NIO laser imaging system, Invenio Imaging, Santa Clara, CA, USA). A previously published New York University AI algorithm (NYU-AI) that is based on the Inception-ResNet-v2 CNN architecture was used to generate three-color overlays to assist in interpretation. SRH images were reviewed by blinded urologists using this AI-enhanced output. Key findings and limitations: NYU-AI identified positive surgical margins in 22% of patients, with no statistically significant difference in comparison to cryo-HE (p > 0.05). Patient-based analysis yielded sensitivity and a negative predictive value (NPV) of 1.0, specificity of 0.93, and a positive predictive value of 0.75. Sample-based analysis showed similar performance, with specificity of 0.97 and identical sensitivity and NPV. These findings indicate strong diagnostic agreement between NYU-AI and conventional intraoperative pathology. Limitations of the study include the small patient cohort, the single-center design, previous training of the NYU-AI tool on prostate biopsy and periprostatic surgical-bed samples, and the lack of testing of interobserver agreement. Conclusions and clinical implications: Our preliminary findings support the potential of SRH with NYU-AI for intraoperative detection of positive surgical margins during RARP. Implementation of this technique should be further discussed after more studies have been conducted. (c) 2025 The Author(s). Urology. This is an open urgery to remove the prostate. Our preliminary results show be an alternative to the current standard as it provides accu-Published by Elsevier B.V. on behalf of European Association of access article under the CC BY license (http://creativecommons. org/licenses/by/4.0/).