This clinical trial tests the feasibility of assessing surgical margins using non-linear microscopy during surgery (intraoperatively) to preserve nerve tissue for patients undergoing surgical removal of the entire prostate gland and surrounding tissue (radical prostatectomy). Non-linear microscopy (NLM) uses an instrument called a nonlinear microscope to detect cancer cells in prostate tissue and other specimens that have been removed from the body. The use of NLM may allow surgeons to better spare nerves near the prostate by providing more information to the surgical team. Leaving these nerves in the body has been shown to lead to better sexual function and bladder control after surgery. Assessing surgical margins intraoperatively with NLM may be a feasible way to preserve nerve tissue for patients undergoing radical prostatectomy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07516808.
Locations matching your search criteria
United States
Massachusetts
Boston
Beth Israel Deaconess Medical CenterStatus: Active
Contact: Peter Chang
PRIMARY OBJECTIVES:
I. Assess the feasibility of participant enrollment for intraoperative margin assessment of prostate specimen using NLM.
II. Assess the feasibility of conducting intraoperative NLM-based specimen margin evaluation with immediate pathologic feedback.
SECONDARY OBJECTIVE:
I. To evaluate the correspondence between NLM surface-imaging-based margin evaluation and standard slice-based formalin-fixed paraffin-embedded (FFPE) histology.
OUTLINE:
Patients undergo standard of care radical prostatectomy surgery with initial full bilateral or unilateral nerve-sparing. Once the prostate specimen is removed from the patient, the specimen is examined using NLM evaluation by the pathologist. Upon completion of the evaluation, the pathologist shares their findings with the surgeon and, if extensive positive margins are found, the surgeon completes a secondary resection of the area.
After completion of study intervention, patients are followed up for up to 30 days.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationDana-Farber Cancer Institute
Principal InvestigatorPeter Chang
