NCT07516808

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
13mo left

Started Jun 2026

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Jun 2026Aug 2027

First Submitted

Initial submission to the registry

April 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2027

Last Updated

April 8, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

April 1, 2026

Last Update Submit

April 1, 2026

Conditions

Prostate Cancer

Keywords

Prostate CancerIntraoperative imaging

Outcome Measures

Primary Outcomes (3)

  • 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 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

    Up to 30 days post-surgery.

Study Arms (1)

Nonlinear Microscopy

EXPERIMENTAL

Enrolled participants will undergo standard-of-care robot-assisted radical prostatectomy surgery utilizing NLM (Nonlinear Microscopy)

Device: Nonlinear Microscope (NLM)

Interventions

Nonlinear Microscope (NLM)DEVICE

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

Nonlinear Microscopy

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale or assigned male at birth (AMAB).
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Peter Chang, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Chang, MD

CONTACT

617-667-3739pchang@bidmc.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Invesitgator

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 8, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

August 28, 2026

Study Completion (Estimated)

August 28, 2027

Last Updated

April 8, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data can be shared no earlier than 1 year following the date of publication
Access Criteria
Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu

Locations

US(1)