Clinical trial · Interventional
PRISM-NLM: Prostatectomy Intraoperative Surgical Margin Assessment With Non-linear Microscopy
NCT07516808CI-TRIAL-00107666not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nonlinear Microscope (NLM) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nonlinear Microscopy
- description
- Enrolled participants will undergo standard-of-care robot-assisted radical prostatectomy surgery utilizing NLM (Nonlinear Microscopy)
- interventionNames
- Device: Nonlinear Microscope (NLM)
Primary outcomes (3)
- measure
- Enrollment Success Rate
- timeFrame
- From screening through informed consent completion (up to Day 0 or baseline visit).
- description
- Enrollment success rate is defined as the proportion of eligible participants enrolled relative to the prespecified enrollment target.
- measure
- Retention Success Rate
- timeFrame
- Up to 30 days post-surgery.
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.