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

This study is testing a new imaging device called a Nonlinear Microscope (NLM) to see if it can help surgeons better assess surgical margins during prostatectomy (surgery to remove the prostate) for prostate cancer. The NLM quickly images the surface of the removed prostate to check for any remaining cancer. The study aims to see how successful it is to enroll participants, keep them in the study, and if the NLM technology works well within the surgical process. You may be able to join if you are a man, 18 or older, have localized prostate cancer, and are having a radical prostatectomy at BIDMC. About 20 people are expected to participate, but the current recruitment status is unclear.

Study design
This is a single-arm study, meaning all participants receive the same intervention. It aims to enroll about 20 participants.
What's involved
You would undergo screening for eligibility and a standard radical prostatectomy surgery.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for up to 30 days after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07516808

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

Not Yet Recruiting
NAAges 18+InterventionalDiagnostic
Beth Israel Deaconess Medical Center
~20 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:Nonlinear Microscope (NLM)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Enrollment Success Rate
Measured over From screening through informed consent completion (up to Day 0 or baseline visit).
+2 more outcomes measured

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Peter Chang, MD · PRINCIPAL_INVESTIGATOR · Beth Israel Deaconess Medical Center

Who to contact

Peter Chang, MD
[email protected]
617-667-3739
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Enrollment Success RateFrom 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 RateUp 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 RateOn 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.