Feasibility of Timesaving When Using Histolog Confocal Laser Endomicroscopy for Margin Assessment in Prostatectomy Specimen
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Histolog Scan.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device 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 ca
Primary outcome measures
- Proportion of Surgeries with Histolog Scanner Attributable Time-Saving Greater Than 20 Minutes [Time frame: Immediately after procedure]
Secondary outcome measures (4)
- Agreement Between Histolog and Final Histopathology Assessment [Time frame: Immediately after procedure]
- System Usability Scale (SUS) [Time frame: "Baseline" or "Day 1" and through study completion, an average of 1 year]
- Pathologist Usability Scale (PUS) score [Time frame: "Baseline" or "Day 1" and through study completion, an average of 1 year]
- Count and percentage of specimens where the Histolog Dip impacted the ability to make final margin assessments in pathology [Time frame: Immediately after procedure]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Icahn School of Medicine at Mount Sinai — New York
Identifiers
NCT: NCT07141121 · STUDY-24-01611