Back to search results

Feasibility of Histolog Confocal Laser Endomicroscopy for Prostatectomy Margin Assessment

This study is testing a new device called the Histolog Scanner to see if it can quickly find cancer cells on the surface of the prostate after it's removed during surgery for prostate cancer. The goal is to make sure all cancer is removed while also preserving nerves that are important for quality of life. The Histolog Scanner uses high-resolution imaging to look at fresh tissue. Researchers want to see if using the Histolog Scanner can save more than 20 minutes of surgery time. You might be able to join if you have localized or locally advanced prostate cancer, are scheduled for robot-assisted radical prostatectomy, and haven't had previous treatment for prostate cancer. The study is currently unclear on its recruitment status and plans to enroll 78 men.

Study design
This is an interventional study planning to enroll 78 participants. It is not specified if it is randomized or blinded.
What's involved
Upon prostate removal, your prostate will be scanned using the Histolog Scanner on five different sides. This involves dipping the prostate in a fluorescent dye, rinsing it, and then scanning it.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured immediately after the procedure, focusing on time-saving.

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

NCT07141121

Feasibility of Timesaving When Using Histolog Confocal Laser Endomicroscopy for Margin Assessment in Prostatectomy Specimen

Recruiting
NAAges 18+Interventional
Icahn School of Medicine at Mount Sinai
~78 participants
Updated 2025-10-07 on ClinicalTrials.gov
What's tested:Histolog Scan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Surgeries with Histolog Scanner Attributable Time-Saving Greater Than 20 Minutes
Measured over Immediately after procedure

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Ashutosh K. Tewari, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Monali Fatterpekar, PhD
[email protected]
(347) 675-8024 · ext. +1
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Localized or locally advanced prostate cancer D'Amico intermediate or high-risk disease.
Indicated for robot-assisted radical prostatectomy
Treatment naive.
Age ≥ 18 years.
Ability to understand and the willingness to sign a written informed consent.

Exclusion

Patients who have received pelvic radiation previously for prostate cancer or any other malignancy.
Patients who have previously received androgen deprivation or other hormonal treatments, or focal therapy of prostate cancer prior to radical prostatectomy.
Patients with D'Amico Criteria low risk prostate cancer.

What this trial measures

  • Proportion of Surgeries with Histolog Scanner Attributable Time-Saving Greater Than 20 MinutesImmediately after procedure

    Defined as a positive difference of time taken using NeuroSafe technique vs time taken by Histolog scanner in margin assessment.