PRISM-NLM: Prostatectomy Intraoperative Surgical Margin Assessment With Non-linear Microscopy
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Enrollment Success Rate
Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years old.
- •Male or assigned male at birth (AMAB).
- •Initial diagnosis of localized PrCa.
- •Undergoing radical prostatectomy at BIDMC as part of their standard of care.
Exclusion Criteria
- •No short-form available in the participant's language.
- •Cognitively unable to provide consent, in the opinion of the investigator.
- •Patients with evidence of unequivocal radiologic bilateral extraprostatic extension (EPE) on most recent MRI results.
- •Patients with \>80 cc prostate volume (larger prostates would require potentially excessive evaluation time).
Arms & Interventions
Nonlinear Microscopy
Enrolled participants will undergo standard-of-care robot-assisted radical prostatectomy surgery utilizing NLM (Nonlinear Microscopy)
Intervention: Nonlinear Microscope (NLM) (Device)
Outcomes
Primary Outcomes
Enrollment Success Rate
Time Frame: From screening through informed consent completion (up to Day 0 or baseline visit).
Enrollment success rate is defined as the proportion of eligible participants enrolled relative to the prespecified enrollment target.
Retention Success Rate
Time Frame: Up to 30 days post-surgery.
Retention success rate is defined as the probability of enrolled participants who completed the required study procedures and the follow-up period.
Technical and Workflow Feasibility Rate
Time Frame: On the day of robot-assisted radical prostatectomy (Day 0)
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.
Secondary Outcomes
- Concordance of Surgical Margin Status Between Intraoperative Nonlinear Microscopy (NLM) and Postoperative Formalin-Fixed Paraffin-Embedded Hematoxylin and Eosin (FFPE H&E) Assessment(Up to 30 days post-surgery.)
Investigators
Peter Chang
Principal Invesitgator
Beth Israel Deaconess Medical Center