PRISM-NLM: Prostatectomy Intraoperative Surgical Margin Assessment With Non-linear Microscopy

PRISM-NLM: Prostatectomy Intraoperative Surgical Margin Assessment With Non-linear Microscopy

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.

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.

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).