Status:
RECRUITING
Feasibility of Timesaving When Using Histolog Confocal Laser Endomicroscopy for Margin Assessment in Prostatectomy Specimen
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
SamanTree Medical SA
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 h...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 13 2026
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT07141121
Start Date
May 13 2025
End Date
May 13 2026
Last Update
October 7 2025
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029