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NCT Number: NCT07516808

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, 02215, United States

Location contact

Peter Chang, MD

CONTACT

[email protected]

617-667-3739

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Nonlinear Microscope (NLM)

Device

The nonlinear microscope (NLM) is an imaging device used for intraoperative imaging of prostatectomy specimens to assess surgical margins.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Concordance of Surgical Margin Status Between Intraoperative Nonlinear Microscopy (NLM) and Postoperative Formalin-Fixed Paraffin-Embedded Hematoxylin and Eosin (FFPE H&E) Assessment

    Time frame: Up to 30 days post-surgery.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Chang, MD

CONTACT

[email protected]

617-667-3739

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Massachusetts Institute of Technology
  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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