Prostate Cancer
Conditions
Keywords
Prostate Cancer, Intraoperative imaging
Brief summary
This study will evaluate the use of intraoperative nonlinear microscopy (NLM) for surgical margin assessment during nerve-sparing radical prostatectomy in participants with prostate cancer.
Detailed description
This prospective, single-arm feasibility study is to evaluate the use of intraoperative nonlinear microscopy (NLM) for surgical margin assessment during nerve-sparing robot-assisted laparoscopic radical prostatectomy (RP) in participants with prostate cancer. A nonlinear microscope is a rapid imaging technology that can quickly image the surface of the prostate after it has been removed from the body to see if there is any cancer left behind. The U.S. Food and Drug Administration (FDA) has not approved the NLM device for use in assessing radical prostatectomy surgical specimens but has been approved for other uses. The research study procedures include screening for eligibility and standard of care radical prostatectomy surgery. It is expected about 20 people will participate in this research study. The National Institutes of Health is supporting this research study by providing study funds. The Masssachusetts Institute of Technology (MIT) is supporting this research by providing the nonlinear microscope.
Interventions
DEVICENonlinear Microscope (NLM)
The nonlinear microscope (NLM) is an imaging device used for intraoperative imaging of prostatectomy specimens to assess surgical margins.
Sponsors
Beth Israel Deaconess Medical Center
National Cancer Institute (NCI)
Massachusetts Institute of Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old. * Male or assigned male at birth (AMAB). * Initial diagnosis of localized PrCa. * Undergoing radical prostatectomy at BIDMC as part of their standard of care.
Exclusion criteria
* No short-form available in the participant's language. * Cognitively unable to provide consent, in the opinion of the investigator. * Patients with evidence of unequivocal radiologic bilateral extraprostatic extension (EPE) on most recent MRI results. * Patients with \>80 cc prostate volume (larger prostates would require potentially excessive evaluation time).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment Success Rate | From screening through informed consent completion (up to Day 0 or baseline visit). | Enrollment success rate is defined as the proportion of eligible participants enrolled relative to the prespecified enrollment target. |
| Retention Success Rate | Up to 30 days post-surgery. | Retention success rate is defined as the probability of enrolled participants who completed the required study procedures and the follow-up period. |
| Technical and Workflow Feasibility Rate | On the day of robot-assisted radical prostatectomy (Day 0) | Feasibility rate is defined as the proportion of enrolled participants undergoing robot-assisted radical prostatectomy for whom intraoperative NLM-based specimen margin evaluation meets all predefined feasibility criteria, including timely actionable pathologic feedback, effective real-time communication, and the ability to perform secondary NVB resection when indicated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concordance of Surgical Margin Status Between Intraoperative Nonlinear Microscopy (NLM) and Postoperative Formalin-Fixed Paraffin-Embedded Hematoxylin and Eosin (FFPE H&E) Assessment | Up to 30 days post-surgery. | Surgical margins will be classified as positive or negative by both intraoperative NLM and postoperative FFPE H\&E, with FFPE H\&E serving as the reference standard. The unit of analysis for concordance will be per side, aligning with the unit of surgical action. Concordance will be evaluated by comparing margin status determinations across corresponding margin locations. Separate concordance estimates will be calculated for initial nerve-sparing excision specimens (typically 1-2 per participant) and for neurovascular bundle secondary resections, which are relatively rare and are expected in approximately 1-2 per 20 participants. |
Countries
United States
Contacts
CONTACTPeter Chang, MD
PRINCIPAL_INVESTIGATORPeter Chang, MD
Beth Israel Deaconess Medical Center
Outcome results
None listed