Nonlinear Microscopy for Prostate Cancer

Overseen By Peter Chang, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Cognitive impairment, Large prostate, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Day 0

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Peter Chang, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 years old or older.

I am male or was assigned male at birth.

I was first diagnosed with prostate cancer that had not spread.

Exclusion Criteria

I am not able to understand or agree to the study on my own.

Patients with evidence of unequivocal radiologic bilateral extraprostatic extension (EPE) on most recent MRI results

My prostate volume is 80 cc or less.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to Day 0

Treatment

Participants undergo standard-of-care robot-assisted radical prostatectomy surgery utilizing Nonlinear Microscopy (NLM)

Day 0

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including evaluation of surgical margin status concordance

Up to 30 days post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Prostatectomy Intraoperative Surgical Margin Assessment With Non-linear Microscopy

How Is the Trial Designed?

Group I: Nonlinear Microscopy Experimental Treatment 1 Intervention

Enrolled participants will undergo standard-of-care robot-assisted radical prostatectomy surgery utilizing NLM (Nonlinear Microscopy)

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Massachusetts Institute of Technology

Collaborator

Trials

104

Recruited

12,810,000+