PRISM-NLM: Prostatectomy Intraoperative Surgical Margin Assessment With Non-linear Microscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nonlinear Microscope (NLM).
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device Nonlinear Microscope (NLM)
The nonlinear microscope (NLM) is an imaging device used for intraoperative imaging of prostatectomy specimens to assess surgical margins.
Primary outcome measures
- Enrollment Success Rate [Time frame: From screening through informed consent completion (up to Day 0 or baseline visit).]
- Retention Success Rate [Time frame: Up to 30 days post-surgery.]
- Technical and Workflow Feasibility Rate [Time frame: On the day of robot-assisted radical prostatectomy (Day 0)]
Secondary outcome measures (1)
- Concordance of Surgical Margin Status Between Intraoperative Nonlinear Microscopy (NLM) and Postoperative Formalin-Fixed Paraffin-Embedded Hematoxylin and Eosin (FFPE H&E) Assessment [Time frame: Up to 30 days post-surgery.]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Beth Israel Deaconess Medical Center (BIDMC) — Boston
Identifiers
NCT: NCT07516808 · 25-735 · R01CA249151