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Clinical Trials in Israel / NCT07516808
Starting soon Not applicable

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

NCT07516808 · tracked via the Priya Life Science Israel tracker
Sponsor
Beth Israel Deaconess Medical Center
Phase
Not applicable
Started
2026-06
Last updated
2026-04-08

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

Nonlinear Microscope (NLM)

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

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
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).

Primary outcome measure(s)

  • Enrollment Success Rate — 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 — 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 — 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.

Trial sites (1)

FacilityCityRegionStatus
Beth Israel Deaconess Medical Center (BIDMC) Boston Massachusetts

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07516808 on ClinicalTrials.gov ↗ ← All trials in Israel