This study will evaluate the use of intraoperative nonlinear microscopy (NLM) for surgical margin assessment during nerve-sparing radical prostatectomy in participants with prostate cancer.
This prospective, single-arm feasibility study is to evaluate the use of intraoperative nonlinear microscopy (NLM) for surgical margin assessment during nerve-sparing robot-assisted laparoscopic radical prostatectomy (RP) in participants with prostate cancer. A nonlinear microscope is a rapid imaging technology that can quickly image the surface of the prostate after it has been removed from the body to see if there is any cancer left behind. The U.S. Food and Drug Administration (FDA) has not approved the NLM device for use in assessing radical prostatectomy surgical specimens but has been approved for other uses. The research study procedures include screening for eligibility and standard of care radical prostatectomy surgery. It is expected about 20 people will participate in this research study. The National Institutes of Health is supporting this research study by providing study funds. The Masssachusetts Institute of Technology (MIT) is supporting this research by providing the nonlinear microscope.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
The nonlinear microscope (NLM) is an imaging device used for intraoperative imaging of prostatectomy specimens to assess surgical margins.
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States
Enrollment Success Rate
Enrollment success rate is defined as the proportion of eligible participants enrolled relative to the prespecified enrollment target.
Time frame: From screening through informed consent completion (up to Day 0 or baseline visit).
Retention Success Rate
Retention success rate is defined as the probability of enrolled participants who completed the required study procedures and the follow-up period.
Time frame: Up to 30 days post-surgery.
Technical and Workflow Feasibility Rate
Feasibility rate is defined as the proportion of enrolled participants undergoing robot-assisted radical prostatectomy for whom intraoperative NLM-based specimen margin evaluation meets all predefined feasibility criteria, including timely actionable pathologic feedback, effective real-time communication, and the ability to perform secondary NVB resection when indicated.
Time frame: On the day of robot-assisted radical prostatectomy (Day 0)
Concordance of Surgical Margin Status Between Intraoperative Nonlinear Microscopy (NLM) and Postoperative Formalin-Fixed Paraffin-Embedded Hematoxylin and Eosin (FFPE H&E) Assessment
Surgical margins will be classified as positive or negative by both intraoperative NLM and postoperative FFPE H\&E, with FFPE H\&E serving as the reference standard. The unit of analysis for concordance will be per side, aligning with the unit of surgical action. Concordance will be evaluated by comparing margin status determinations across corresponding margin locations. Separate concordance estimates will be calculated for initial nerve-sparing excision specimens (typically 1-2 per participant) and for neurovascular bundle secondary resections, which are relatively rare and are expected in approximately 1-2 per 20 participants.
Time frame: Up to 30 days post-surgery.
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