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

ID#: NCT07141121

Age: 18 years - 66+

Gender: Male

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: May 13, 2025

End Date: May 13, 2026

Contact Information:
Monali Fatterpekar, PhD
(347) 675-8024
Henry W. Jodka, BA
203-939-5115
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:

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.