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Completed
NCT07141121
Feasibility of Timesaving When Using Histolog Confocal Laser Endomicroscopy for Margin Assessment in Prostatectomy Specimen
Conditions: Prostate Cancer
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 78
Sponsor: Icahn School of Medicine at Mount Sinai
Location: Icahn School of Medicine at Mount Sinai New York New York
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.
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.
Source: ClinicalTrials.gov (NCT07141121). StuddyBuddy aggregates publicly available trial information.