Faster Histolog confocal scanning for checking prostatectomy margins
Feasibility of Timesaving When Using Histolog Confocal Laser Endomicroscopy for Margin Assessment in Prostatectomy Specimen
The Histolog Scanner will be tried during robot-assisted radical prostatectomy to see if it can quickly and safely spot cancer at the prostate edge in patients with intermediate or high-risk prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07141121 on ClinicalTrials.gov |
What this trial studies
This feasibility study uses the Histolog Scanner, an ultra-fast confocal microscope, to image the surface of fresh prostate specimens during robot-assisted radical prostatectomy and compare the time burden to traditional NeuroSafe margin assessment. Surgeons will use the device intraoperatively to guide margin decisions while investigators record time, workflow impact, and margin integrity. The protocol includes an economic analysis using U.S. market prices to estimate potential cost and time savings in the American clinical setting. Results will inform whether a larger clinical trial is warranted to adopt this approach for routine intraoperative margin evaluation.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with treatment-naive, localized or locally advanced D'Amico intermediate or high-risk prostate cancer who are scheduled for robot-assisted radical prostatectomy and can give informed consent.
Not a fit: Patients with low-risk disease, prior pelvic radiation, prior androgen-deprivation or other hormonal/focal prostate treatments are excluded and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could shorten intraoperative margin checks and help surgeons preserve nerves without adding time or cost to surgery.
How similar studies have performed: Confocal imaging for margin assessment is an emerging approach and the Histolog Scanner is recently FDA-cleared with early promising reports, but robust U.S. data on time and cost savings are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Ashutosh K. Tewari, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Monali Fatterpekar, PhD
- Email: monali.fatterpekar@mountsinai.org
- Phone: (347) 675-8024
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.