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

NCT ID: NCT07141121

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-13
• Study Completion Date: 2026-05-13

Brief Summary

This study investigates a new, faster way to find cancer cells on the surface of the prostate during radical prostatectomy surgery. A recently FDA-approved device, called the Histolog Scanner, gives high-resolution imaging of the surface of fresh tissue using ultra-fast confocal microscopy, which allows physicians to make surgical decisions quickly.

Detailed Description

The goal of this time saving feasibility study is to gain early insights into whether Histolog Scanner can maintain the integrity and safety of NeuroSafe margin assessment while alleviating the heavy time burden of NeuroSafe in the US setting before starting a larger clinical trial. This way, patients can be offered optimal nerve sparing without adding to the administrative burden and cost associated with NeuroSafe. What is new about the study is that the researchers intend to do a cost and time economics analysis using United States market prices that will inform discussions in the future about the utility of this device in the United States.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients undergoing robotic-assisted radical prostatectomy

Patients undergo standard of care (SOC) robotic-assisted radical prostatectomy. The patients' removed prostates are then evaluated with the Histolog Scanner. Patients also undergo SOC blood sample collection, rectal examination, MRI, and micro ultrasound imaging, as well as have their medical records reviewed throughout the trial.

Group Type: EXPERIMENTAL

Histolog Scan

Intervention Type: DEVICE

Upon prostate removal, the prostate is taken to the Histolog scanner, dipped in proprietary fluorescent dye, rinsed with saline, and then scanned on five different sides. This involves simply placing the prostate on the surface of the scanner and acquiring images on each side, giving a high-resolution (cellular level) microscopic imaging of the prostate's surfaces. Once images are collected, the prostate is returned to the pathology lab to undergo the NeuroSafe procedure, which is standard of care (SOC).

Interventions

Histolog Scan

Upon prostate removal, the prostate is taken to the Histolog scanner, dipped in proprietary fluorescent dye, rinsed with saline, and then scanned on five different sides. This involves simply placing the prostate on the surface of the scanner and acquiring images on each side, giving a high-resolution (cellular level) microscopic imaging of the prostate's surfaces. Once images are collected, the prostate is returned to the pathology lab to undergo the NeuroSafe procedure, which is standard of care (SOC).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

SamanTree Medical SA

INDUSTRY

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Ashutosh Kumar Tewari

Professor and System Chairman, Department of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashutosh K. Tewari, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Monali Fatterpekar, PhD

Role: CONTACT

monali.fatterpekar@mountsinai.org

(347) 675-8024 ext. +1

Henry W. Jodka, BA

Role: CONTACT

henry.jodka@mountsinai.org

203-939-5115 ext. +1

Facility Contacts

Monali Fatterpekar, PhD

Role: primary

monali.fatterpekar@mountsinai.org

347-675-8024

Henry W Jodka, BA

Role: backup

henry.jodka@mountsinai.org

(203) 939-5115

Other Identifiers

STUDY-24-01611

Identifier Type: -

Identifier Source: org_study_id