PRISM-NLM: Prostatectomy Intraoperative Surgical Margin Assessment With Non-linear Microscopy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Nonlinear Microscope (NLM)

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Chang, MD; Phone Number: 617-667-3739; Email: pchang@bidmc.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center (BIDMC)
      • Contact: Peter Chang, MD; Phone Number: 617-667-3739; Email: pchang@bidmc.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nonlinear Microscopy; Enrolled participants will undergo standard-of-care robot-assisted radical prostatectomy surgery utilizing NLM (Nonlinear Microscopy)	Device: Nonlinear Microscope (NLM); The nonlinear microscope (NLM) is an imaging device used for intraoperative imaging of prostatectomy specimens to assess surgical margins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment Success Rate	Enrollment success rate is defined as the proportion of eligible participants enrolled relative to the prespecified enrollment target.	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.	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.	On the day of robot-assisted radical prostatectomy (Day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 30 days post-surgery.

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: National Cancer Institute (NCI); Massachusetts Institute of Technology
• Investigators: Principal Investigator: Peter Chang, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): August 28, 2027

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Prostate Cancer; Intraoperative imaging
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 25-735; R01CA249151 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes