Prostate Cancer
Conditions
Keywords
Confocal Microscopy, Histolog Scanner, NeuroSafe, Surgical Margins, Feasibility, Radical Prostatectomy
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.
Interventions
DEVICEHistolog 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).
Sponsors
SamanTree Medical SA
Icahn School of Medicine at Mount Sinai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Surgeries with Histolog Scanner Attributable Time-Saving Greater Than 20 Minutes | Immediately after procedure | Defined as a positive difference of time taken using NeuroSafe technique vs time taken by Histolog scanner in margin assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agreement Between Histolog and Final Histopathology Assessment | Immediately after procedure | The Kappa statistic (Cohen's Kappa) will be used to assess agreement between Histolog and final histopathology assessment. 95% CI will be calculated using the Wilson's method without continuity correction. |
| System Usability Scale (SUS) | Baseline or Day 1 and through study completion, an average of 1 year | System Usability Scale (SUS) ranges between 8-40. Each question asks about ease of use of the Histolog Scanner, and the operator answers each of the 8 questions on a scale of 1 (strongly disagree) to 5 (strongly agree). Any SUS score greater than or equal to 32 will be interpreted as high usability. Operator will be asked to complete after the completion of every 10 procedures and again after the final procedure. |
| Pathologist Usability Scale (PUS) score | Baseline or Day 1 and through study completion, an average of 1 year | Pathologist Usability Scale (PUS) ranges between 6-30. Each question asks about the ease of use of the Histolog Scanner, and the pathologist answers each of the 6 questions on a scale of 1 (strongly disagree) to 5 (strongly agree). Any PUS score greater than or equal to 25 will be interpreted as high pathologist usability. Pathologist will be asked to complete after the completion of every 10 procedures and again after the final procedure. |
| Count and percentage of specimens where the Histolog Dip impacted the ability to make final margin assessments in pathology | Immediately after procedure | Count and percentage of specimens where the Histolog Dip impacted the ability to make final margin assessments in pathology |
Countries
United States
Contacts
Primary ContactMonali Fatterpekar, PhD
Backup ContactHenry W. Jodka, BA
Outcome results
None listed