NCT07141121 Feasibility of Timesaving When Using Histolog Confocal Laser Endomicroscopy for Margin Assessment in Prostatectomy Specimen
| NCT ID | NCT07141121 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2025-05-13 |
| Primary Completion | 2026-05-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 78 participants in total. It began in 2025-05-13 with a primary completion date of 2026-05-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Ashutosh K. Tewari, MD
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT07141121 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07141121 currently recruiting?
Yes, NCT07141121 is actively recruiting participants. Contact the research team at monali.fatterpekar@mountsinai.org for enrollment information.
Where is the NCT07141121 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07141121 clinical trial?
NCT07141121 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Ashutosh K. Tewari, MD at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 78 participants.
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